Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Familial Pancreatic Cancer

Pancreatic cancer patients or family member.

Questionnaire taking about 30-40 minutes to complete.

Questionnaire

Carrie Daniel-MacDougall, PHD

The goal of this research study is to investigate the role of genes that may point to a higher risk of developing pancreatic cancer.

Participants in this study will be part of a pancreatic cancer genetic epidemiology consortium (herein referred to as "PACGENE"), which includes researchers at these institutions: Mayo Clinic; Johns Hopkins University; Creighton University; University of Toronto Mount Sinai Hospital; Dana Farber; and Karmanos Cancer Institute. Participants have either been diagnosed with pancreatic cancer or are family members of pancreatic cancer patients.

Participants will be asked questions by a trained interviewer using an approved questionnaire. The topics will include demographic data (age, race, etc.), exposures, medical history data, family history of cancer and other conditions, and other lifestyle factors. It should take about 30-40 minutes to complete the questionnaire.

Participants in this study will also have about one and a half tablespoons of blood drawn. Blood that is collected will only be used by researchers involved in this study. If obtaining a blood sample is not possible, the study staff will ask for a saliva sample using an ORAGENE kit. Neither participants nor their physicians will receive individual reports of this research. Results will not be placed in the participant's health records. All information will be kept confidential and used only for this research.

There is a rare chance that a research team member could be accidentally exposed to your blood or body fluids. If that occurs, extra blood (about 2 teaspoons) may be drawn to test for infections such as hepatitis and HIV (the AIDS virus). An existing blood sample may be used for these tests instead. You will be told that your blood is being tested and the results of your test. Researchers will ask how you would like to receive the results, such as by phone or certified letter. The test results and your name, address, date of birth, and sex will be recorded in the confidential M. D. Anderson medical records.

If you test positive for hepatitis or HIV, the test results and your name, address, date of birth, and sex will be shared with appropriate health authorities as required by law. You will also be given a list of places in your area so that you can receive further testing and treatment.

For the protection of your privacy, the study staff has obtained a Certificate of Confidentiality from the National Institutes of Health. With this certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the certificate to resist any demands for information that would identify you, except as explained below.

The certificate cannot be used to resist a demand for information from personnel of the United State Government that is used for auditing or evaluation of Federally funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).

You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the certificate to withhold that information.

This is an investigational study. This study will include a total of 1,000 participants recruited at M. D. Anderson.

Pancreatic Cancer Genetic Epidemiology (PACGENE) Study

Data collection from patient response to 30-40 minute questionnaire and blood test.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Gloria Petersen, PhD

Currently, there is no clear legal or ethical guidance about how researchers and IRBs ought to proceed when the research participant in a biobank is deceased and there is clinically relevant information that could be disclosed to family members. This study is designed to test a procedure offering genetic information to family members of research participants who participated in a pancreatic cancer biobank in a Health Insurance Portability and Accountability Act (HIPAA) -compliant design.

To develop, prototype, and evaluate a novel procedure for offering probands' genetic results to family members. The intervention is to offer a deceased research participant's actionable germline genetic research finding, and depending upon the choice made by the next of kin, a disclosure of the research finding by a genetic counselor in a family conference call. Using mixed methods (quantitative and qualitative), the investigators will assess decision making, family communication, and actions and responses in individuals from families in which a proband is known to have a deleterious germline mutation in one of several known cancer susceptibility genes.

Understanding Genetic Incidental Findings in Your Family (UNIFY Study)

Genomic Incidental Findings Disclosure (GIFD) in a Cancer Biobank: An Ethical, Legal and Social Implications (ELSI) Experiment (Protocol for Aim 3 Intervention)

The primary outcome is: relative proportions of individuals who, when offered genetic results of a deceased family member who participated in a biobank study, will decide to learn those results. Uptake will be a binary outcome (Yes/No). We will enumerate the number of invited participants who choose to learn results and who choose not to learn results.

We will measure and compare changes between baseline and 6 months following genetic test disclosure: number of self-reported days per week and exercise duration(minutes).

We will measure and compare changes between baseline and 6 months following genetic test disclosure: number of drinks containing alcohol taken per week over previous six months; frequency drinking 6 or more drinks in one occasion in past 6 months (Never; Less than monthly; Monthly; 2 to 3 times per week; 4 or more times per week)

We will measure and compare changes between baseline and 6 months following genetic test disclosure: Current cigarette smoker (Yes/No)

We will measure and compare changes between baseline and 6 months following genetic test disclosure: Quality of sleep (Very good; Fairly good; Fairly bad; Very bad); Number of hours of sleep in a 24 hour period (hours and minutes)

We will measure and compare changes between baseline and 6 months following genetic test disclosure: Number of servings eaten in a typical day (None; 1 or less; 2; 3; 4; 5 or more)

We will measure and compare changes between baseline and 6 months following genetic test disclosure: Number of times consumed per typical week (0; 1 to 5; 6 to 10; 11 to 15; 16 to 20; 21 or more).

The relative proportion of individuals who request and obtain genetic testing on their own by 6 months

Changes in self-reported quality of life on a scale of 0(a bad as it can be) to 10 (as good as it can be)

Changes in self-reported worry of developing cancer on a scale of 1 (not at all or rarely to 4 (almost all the time)

Self-reported rating of regret to learn/not learn their relative's genetic research result using a 5-item scale rating (Strongly agree to Strongly disagree).

University of Minnesota

University of California, San Francisco

Mayo Clinic

Symptoms and General Pathology

Cholangiocarcinoma

Duodenal Neoplasms

Cysts

Precancerous Conditions

Pancreatic Cyst

Gallbladder Neoplasms

Bile Duct Neoplasms

Biliary Tract Neoplasms

Biliary Tract Diseases

Gallbladder Diseases

Bile Duct Diseases

Intestinal Neoplasms

Duodenal Diseases

Intestinal Diseases

Bile Duct Cancer

Gallbladder Cancer

Individuals affected with pancreatic adenocarcinoma, with or without a family history of pancreatic adenocarcinoma.

Individuals affected with bile duct cancer, ampullary cancer, duodenal cancer or gallbladder cancer.

Individuals affected with pancreatic neoplasm, cyst or pre-cancerous lesion, with or without a family history of pancreatic adenocarcinoma.

Individuals at high lifetime risk of pancreatic adenocarcinoma due to familial pancreatic cancer or hereditary cancer predisposition.

Healthy individual at general population lifetime risk of pancreatic cancer and related cancers.

Adeline Cuggia, MSc

George Zogopoulos, MD, PhD

The Quebec Pancreas Cancer Study is a prospective clinic-based study consisting of clinical, family history and epidemiologic data, with accompanying biospecimens, from patients diagnosed with either pancreas cancer, a related cancer or a related pre-cancerous condition, and their families.

The objectives of the QPCS are as follows:

1. To study the epidemiology of pancreas cancer, related cancers and related pre-cancerous conditions, including the risk factors and patient outcomes.
2. To characterize the contribution of known hereditary cancer syndromes to pancreas cancer, related cancers, and related pre-cancerous conditions.
3. To identify new genetic and epigenetic changes associated with hereditary pancreas cancer, related cancers, and related pre-cancerous conditions. DNA contains the instructions used in the development and functioning of living organisms, including humans. Epigenetic changes are changes other than changes in the underlying DNA sequence.
4. To study the tumour biology of pancreas cancer and related pre-cancerous conditions. This may include studying the tumour and the environment surrounding the tumour, as well as blood and/or saliva samples. The studies may include characterization of genetic, genomic, transcriptomic, epigenetic, proteomic, and metabolomic changes.
5. To identify and characterize biomarkers associated with pancreas cancer, related cancers and related pre-cancerous conditions.
6. To determine if there are any epidemiological, clinical and outcome (for example, overall survival) associations with the genetic, genomic, epigenetic, transcriptomic, proteomic, metabolomic or other biologic changes that occur in pancreas cancer, related cancers and related pre-cancerous conditions.

Blood and/or saliva samples, tumor/tissue samples.

Quebec Pancreas Cancer Study

Create a knowledge and tissue bank for pancreatic cancer, related pre-cancerous lesions, and related cancers, including patient demographics, type of chemotherapy treatments, type of surgical procedures, other procedures, overall survival, progression-free survival, epidemiological risk factors, genetic factors and characteristics of tumour tissue.

George Zogopoulos

Principal Investigator

Shounak Majumder, M.D.

This study is designed to develop a cohort of individuals without pancreatic cancer, but who are at increased risk of developing it due to family history or genetic predisposition. These high-risk individuals will be asked to provide baseline and annual (serial) follow-up blood samples for the duration of the study funding. Mayo Clinic is part of a national Pancreatic Cancer Detection Consortium (PCDC)\[1\] which aims to establish a high-risk cohort with the goal of validating blood biomarkers (discovered/developed outside of this protocol) using the samples collected serially (annually) that predict or detect pancreatic cancer prior to clinical diagnosis.

The high mortality rate of pancreatic cancer is primarily due to the advanced stage at diagnosis in the majority of cases. The five-year survival rate for this cancer is only 9%, the poorest survival rate of any major cancer, making pancreatic cancer the third leading cancer killer that affects both men and women in the United States. Five-year survival can be improved if the cancer is detected earlier.\[2\] It is thus important to apply cancer genetics, risk assessment, and early detection that can identify a population of high-risk individuals who can benefit from early detection.

A key strategy for effective early detection research in pancreatic cancer is to identify and build longitudinal high-risk cohorts and maintain data from baseline to follow up, and biobanking of repeated (annual) non-invasive biospecimen collections. The research to be performed would compare samples of participants who develop cancer over time compared to those who do not. Tests that would be applied to the biospecimen collections would use subsets of participants in designs that would provide the maximum amount of information about the performance of the assays in predicting who has cancer at an early stage \[3,4\].

The collection of biosamples and data for the family-based biobank resource/registry proposed here is partially funded by NCI funded U01 grants, through the PCDC \[1\]. At Mayo Clinic, NCI grant U01 CA210138 is the funding source. The PCDC is committed to developing a longitudinal cohort (registry) of individuals and family members currently without pancreatic cancer, but who are at high risk due to family history of pancreatic cancer or predisposition gene mutation status. High-risk individuals will be recruited at each site, and biospecimens will be logged, stored, administered, and studied by consensus protocols of members of the PCDC. The maintenance of protocols will be maintained by the PCDC Administrative Core at Mayo Clinic. The PCDC cohort will require a long-term investment and will be most successful with multiple contributing sites.

Cohort Study of Pancreatic Cancer Risk

Enumeration of number of new cases of pancreatic cancer and other cancers that incidentally develop from baseline enrollment among those who enroll in the cohort. This number will be a numerator for a risk ratio. The denominator will be person years at risk starting from age 50.

Participants will complete questionnaires seeking demographic, clinical and family history, and exposures at baseline. We will evaluate by association studies (comparing participants with incident cancer to those who do not develop cancer) in order to discover various characteristics that may be associated with development of cancer. Specific characteristics that will be assessed (comparing participants who develop cancer to those who do not) include age at diagnosis of prevalent cancers, sex, personal history of diabetes, and family history (first and second degree) of pancreatic cancer and other cancers.

Biospecimens collected from patients will be used to assess the performance of potential biomarkers in detecting early pancreatic cancer. Two biomarkers that will be evaluated include serum CA19-9, fasting blood glucose and/or hemoglobin A1C. Additional biomarkers will be proposed and approved by scientific review in the future. We will compare samples collected longitudinally (prior to cancer diagnosis) from participants who develop cancer, to participants who do not develop cancer, and estimate test sensitivity and performance.

Adenocarcinoma

Neoplasms, Cystic, Mucinous, and Serous

Pancreatic Intraductal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Hematinics

Pharmaceutical Solutions

Ferrosoferric Oxide

Parenteral Nutrition Solutions

Patients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) yearly for a minimum of 3 scans.

Patients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) prior to surgery for resection of IPMN.

Patients who undergo chemotherapy prior to resection will have 2 DCE MRI scans; one study scan prior to undergoing neoadjuvant therapy, as well as one study scan following neoadjuvant therapy as part of their pre-operative work up in addition to the standard imaging studies. For patients that do not require chemotherapy treatment prior to resection they will have just one DCE MRI scan prior to surgical resection. Patients currently undergoing neoadjuvant therapy or who have already completed neoadjuvant therapy that were unable to undergo imaging at baseline and are now proceeding to resection will have one DCE MRI scan prior to surgical resection.

Patients undergo a single DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) examination.

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Ferumoxytol

Alexander S. Guimaraes

Alexander Guimaraes

This clinical trial studies an imaging technique known as dynamic contrast enhanced magnetic resonance imaging (DCE MRI) in identifying the presence of pancreatic cancer. DCE MRI is a procedure that takes detailed pictures of functional and structural properties inside the body using magnetic field imaging. These images may better characterize pancreatic cancer in patients at high risk or in patients who may have undergone chemotherapy for pancreatic cancer.

PRIMARY OBJECTIVES:

I. Assess the ability of DCE-MRI to identify the presence of pancreatic cancer in patients at high risk for hereditary pancreatic cancer.

II. Assess the ability of DCE-MRI to identify the presence of pancreatic cancer in patients with cystic lesions of the pancreas.

III. Assess the ability of DCE-MRI to accurately predict tumor margins in patients who have undergone chemotherapy for pancreatic cancer.

IV. Obtain DCE-MRI scans of from healthy volunteers (Group 4), to establish baseline imaging parameters of the normal, non-diseased pancreas for use as a comparator to affected pancreata.

SECONDARY OBJECTIVE:

I. Clinical factors associated with the presence of pancreatic cancer will be assessed in each of the three experimental groups, including disease free survival and overall survival.

II. Additional MRI pulses sequences (e.g. MR fingerprinting, etc.) will be acquired for the assessment of tissue contrast before and after the administration of contrast agents.

OUTLINE: Patients are assigned to 1 of 4 groups.

ARM I (High-risk for familial or hereditary pancreatic cancer): Patients undergo DCE MRI yearly for a minimum of 3 scans.

ARM II (Intraductal papillary mucinous neoplasms \[IPMN\]): Patients undergo DCE MRI prior to surgery for resection of IPMN.

ARM III (Pancreatic cancer): Patients who undergo chemotherapy prior to resection will have 2 DCE MRI scans; one study scan prior to undergoing neoadjuvant therapy, as well as one study scan following neoadjuvant therapy as part of their pre-operative work up in addition to the standard imaging studies. For patients that do not require chemotherapy treatment prior to resection they will have just one DCE MRI scan prior to surgical resection. Patients currently undergoing neoadjuvant therapy or who have already completed neoadjuvant therapy that were unable to undergo imaging at baseline and are now proceeding to resection will have one DCE MRI scan prior to surgical resection.

ARM IV (Healthy volunteers): Patients undergo a single DCE MRI examination.

DCE MRI in Patients With Pancreatic Cancer

The Use of Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE MRI) in the Management of Pancreatic Cancer

Descriptive statistical analysis will be conducted for primary endpoints.

The change of dynamic contrast enhanced magnetic resonance imaging (DCE MRI) parameters from baseline will be correlated with the tumor margins determined by pathological specimen following surgical resection through linear regression model.

Kaplan-Meier method will be used to estimate the survival distribution for disease free survival. The estimated median and 95% confidence interval will be computed.

Kaplan-Meier method will be used to estimate the survival distribution for overall survival. The estimated median and 95% confidence interval will be computed.

Will be assessed as potential confounders or effect modifiers in the model. Will report c-statistics for each model.

The DCE- MRI parameters will be obtained from the pancreases in the control group and will be descriptively analyzed for use as a comparison in other groups.

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Oregon Health and Science University

National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK)

OHSU Knight Cancer Institute

Genetic Predisposition to Disease

Disease Susceptibility

Patients that meet the eligibility criteria based on CAPS3 or updated national pancreatic cancer screening guidelines

Screening for pancreatic cancer using EUS or MRI

Screening for pancreatic cancer

Roya Dastjerdi, MD

Roya Dastjerdi, MPH

Mandeep Sawhney, MD,MS,FASGE

Andy Silva-Santisteban, MD

The investigators' goal is to conduct a prospective multicenter study to evaluate the yield and outcomes of screening of pancreas cancer in individuals who are at-risk for pancreatic cancer. We plan to use International Cancer of the Pancreas Screening (CAPS3) Consortium recommendations to standardize study population, screening methodology, and study outcomes.

Methods The investigators' goal is to conduct a prospective multicenter study to evaluate the yield and outcomes of pancreas cancer screening in high-risk individuals. High-risk patients who are undergoing pancreatic cancer screening in accordance with national guidelines at participating study centers will be eligible for the study. Information regarding patient characteristics, findings at screening examination, and patient outcomes will be collected.

Primary Outcome (Primary Aim):

To identify the proportion of patients who meet International Cancer of the Pancreas Screening Consortium screening criteria 3rd update (CAPS Jan 2020), or more updated national guidelines, who are found at the screening to have high-risk pancreatic lesions amenable to treatment (definition of "high-risk lesions amenable to treatment" is provided under the section on study outcomes).

Secondary outcomes (Secondary Aims) will include (details are provided under the section on study outcomes):

1. Proportion of patients diagnosed with any stage pancreatic cancer
2. proportion of patients undergoing pancreatic surgery
3. Cancer-related outcome, defined as a cancer-related death
4. proportion of patients experience harms, defined as any complications/adverse event due to screen related procedures
5. Comparison of cancer outcome, defined cancer-related death, in screen-detected cancer with cancer outcomes reported by the SEERs population-based registry. Study overview Study type: a prospective observational cohort High-risk patients who meet study inclusion criteria at study centers will be identified.

Screening and patient follow-up will be performed at individual study centers per standard clinical practice. Patient characteristics, screening performed and screening results, clinical outcome data will be collected by individual study centers. This data will be stored and analyzed at central study REDCap located at Beth Israel Deaconess Medical Center (BIDMC)

Pancreatic Cancer Screening for At-risk Individuals

Pancreatic Cancer Screening for At-risk Individuals (The Pancreas Scan Study)

Proportion of patients who meet CAPS 3 or updated national screening guidelines criteria who are found at screening to have high-risk pancreatic lesions amenable to treatment. These are defined as the following: Lesions with high-grade dysplasia (HGD), High-grade pancreatic intraepithelial neoplasia (PanIN), Resectable or borderline resectable pancreatic cancer. Pancreatic cancers that were staged T1-3, N0-2, and M0 designated as resectable or borderline resectable. Cancers that were staged as T4 or M1 were considered locally advanced or metastatic and therefore designated as unresectable, Main duct intra-ductal papillary mucinous neoplasm (IPMN)., Branch-duct IPMN with "worrisome features", cyst associated with an abrupt change in main pancreatic duct caliber with pancreatic atrophy, Neuroendocrine tumor ≥ 2 cm.

Proportion of patients who meet CAPS screening eligibility criteria, who are found at screening to have high-risk pancreatic lesions amenable to treatment

Proportion of patients undergoing pancreatic cancer screening who are found to have low or moderate-risk pancreatic lesions. Low or moderate-risk pancreatic lesions pancreatic lesions are defined as:

1. Branch-duct IPMN without HGD
2. Neuroendocrine tumor \< 2 cm
3. dilation of main pancreatic duct \< 8 mm
4. Chronic pancreatitis-like change

Proportion of patients who undergo pancreatic surgery as a result of screening test results following the Fukuoka revised guidelines for the management for high-risk lesions or surgical treatment designated by interdisciplinary medical team

Proportion of patients who undergo "low-yield pancreatic surgery" as a result of screening test results. Low yield pancreatic surgery is defined surgery where surgical pathology does not yield high-risk pancreatic lesions. See primary outcome for definition of high-risk pancreatic lesions.

Proportion of patients who undergo non- pancreatic surgery as a result of screening test results.

Proportion of patients who experienced any complications or adverse events due to screen-related procedures as Endoscopic Ultrasound (EUS), Magnetic resonance cholangiopancreatography (MRCP) or others that have been designated by attending in the GI department. Complications and adverse events will be aggregated to be reported as one value (complications/adverse events). Complications, defined as adverse events that emphasize direct causality between medical care and the adverse outcome or event. Adverse event, defined as an event that may or may not be preventable or result from a medical error

Wake Forest University Health Sciences

Washington University School of Medicine

Zucker School of Medicine at Hofstra/Northwell

University of Arkansas

Rush University Medical Center

Central Arkansas Veterans Healthcare System

W.G. Bill Hefner Medical Center

Beth Israel Deaconess Medical Center

Co-Director for GI Endoscopy & Director for Endoscopy Research, BIDMC

Skin and Connective Tissue Diseases

Diseases and Abnormalities at or Before Birth

Syndrome

Melanoma

Melanoma, Cutaneous Malignant

Nevus

Dysplastic Nevus Syndrome

Nevus, Pigmented

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Carcinoma

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Neuroendocrine Tumor

Neuroepithelioma

Rolf Ehrnström

PanFAM-1 is a clinical study for early detection of pancreatic cancer in high-risk groups. The goals of the study are to assess the performance and diagnostic accuracy of the IMMray™ PanCan-d test compared to standard-of-care imaging.

PanFAM-1 is a prospective, multi-center, investigational study, designed to assess the performance of the IMMray™ PanCan-d test in early detection of pancreatic ductal adenocarcinoma (PDAC) in high-risk populations. Specifically, the IMMray PanCan-d test uses state of the art machine learning algorithms to condense the multiple fluorescence data points generated by the test to a simple yes/no result. Thus, a highly complex statistical model uses the multi-dimensional nature of the test to generate a score, which is called a decision value. The score is compared to the established cut-off value for the test to inform the operator whether the patient sample is positive or negative for PDAC. This study will validate and evaluate the performance of the IMMray PanCan-d test in comparison to standard of care imaging approaches that are currently used in PDAC disease surveillance. Subjects in this study will be recruited from several European and North American research sites that have a PDAC surveillance program or established protocol for monitoring individuals considered to be at a high-risk for developing pancreatic cancer. Any subject that shows disease progression while on-study will be removed from the study to receive standard of care per institutional guidelines. Overall, this study poses minimal risk to subjects. The PanFAM-1 study is an adaptive study design over two approximately 18 month intervals, which are separated by an interim analysis to evaluate diagnostic accuracy of the IMMray PanCan-d test. This study is an observational period in which blood collections from eligible subjects will be evaluated using the IMMray PanCan-d test. Subjects will undergo scheduled imaging assessment and clinical evaluation consistent with the resarch sites' PDAC surveillance program. Subject data derived from the IMMray PanCan-d test during this portion of the study will be delayed from time of initial blood collection until the samples are analyzed. The analysis will compare IMMray PanCan-d test results for each subject to corresponding imaging assessments performed as part of standard of care PDAC surveillance. The study will only proceed to the interventional period if the interim analysis indicates that the diagnostic accuracy of the IMMray PanCan-d test is capable of detecting PDAC in high-risk subjects with the same or better ability as standard of care imaging. If at any time imaging assessments are considered positive for clinical disease then, regardless of IMMray PanCan-d test results, subjects will be managed according to institutional guidelines. All scheduled blood collections for purposes of this study will be halted and subjects will be removed from the study upon confirmation of PDAC.

A Study of IMMray™ PanCan-d Test for Early Detection of Pancreatic Cancer in High-risk Groups

A Prospective, Multi-center Investigational Study of IMMray™ PanCan-d Diagnostic Assay for Early Detection of Pancreatic Ductal Adenocarcinoma in High-risk Populations

Demonstrate that the IMMray PanCan-d test is equal or better than the reference standard imaging procedures for early detection of PDAC in asymptomatic high risk individuals

Point Estimates and 95% confidence intervals

Immunovia, Inc.

Pancreatitis

Pancreatitis, Chronic

Chronic Disease

Disease Attributes

Hereditary Pancreatitis

Chronic Graft Versus Host Disease

Individual with ten fold higher risk to develop pancreatic cancer.

Matthias Löhr, Professor

Marco del Chiaro, Ass prof.

Marco del Chiaro, ass prof.

Matthias Lohr, Professor

Marco del Chiaro, ass. prof.

Early detection of pre-cancerous lesions or early stage pancreatic cancer seems to have a positive impact in survival for patients with an increased genetic risk to develop pancreas cancer.

In this study, following the indication of the swedish guidelines, consecutive patients with a family history for pancreas cancer underwent a clinical surveillance Magnetic Resonance Imaging (MRI) based. The results of this study were analyzed looking in the patients files collected during the screening period.

Pancreatic cancer is the 4th cause of cancer related deaths in USA and in many of the Western Countries. The incidence of the disease is almost corresponding to the mortality rate. For this reason pancreatic cancer can be considered a global lethal disease. Even if treatments have improved, the resection rate in patients suffering from ductal adenocarcinoma remain around 30% and the 5 years survival rates is below 20%. Because of the low incidence of pancreatic cancer in the general population, a population-based screening is not cost/effective. Anyway in the last two decades, data from literature demonstrate that pancreatic cancer can be the phenotypic expression of some know genetic syndromes and the existence of a familial risk to develop pancreatic cancer. In particular for this last condition, called familial pancreatic cancer (FPC), an increased risk is associated with the number of family member affected. In prospective epidemiological studies, is demonstrated that a positive family history of pancreatic cancer is present in about 10% of all consecutive probands. The identification of a population at risk, the suggestions that an early surgical treatment of pancreatic cancer can improve the prognosis and, in particular, the identifications of pre-neoplastic lesions as PanIN and IPMN associated to the natural history of FPC, contributed to the development on National and International guidelines for the surveillance of the individual at increased risk. Even do, today, no consensus is reached on inclusion criteria for a clinical surveillance program, screening modalities and target lesions. Traditionally individual with a 10 fold relative risk to develop pancreatic cancer were considered suitable for a screening program. However, more recently, the CAPS group suggested to include in a surveillance program individuals with a 5 fold higher relative risk. Early pancreatic cancer, IPMN and PanIN lesions are considered the target lesions of a clinical screening, however the concrete possibility to detect PanIN lesions during a surveillance program remain debatable and uncertain.The imaging modality technique used in the existing programs are, alone or in combination, magnetic resonance (MR), computed tomography (CT), endoscopic ultrasound (EUS), endoscopic retrograde cholagiopancreatography (ERCP). Anyway a tendency to use low aggressive modalities as MR and EUS is emerging by the recent recommendations. The results of the clinical studies are quite uncertain and difficult to compare due to different screening modalities and inclusion criteria. The yield of FPC screening programs published in literature range from 50 to 1.3%. The cost/effectiveness of a surveillance program for FPC is not already demonstrated.

The aim of this study is to analyze the preliminary result of a prospective clinical surveillance program for individuals at risk for pancreatic cancer using a low aggressive, MR based, screening.

Patients enrollment Patients with an increased "genetic" risk to develop pancreatic cancer will be enrolled in a MR surveillance program at Karolinska University Hospital.

The patients were enrolled in the study from 3 different ways: relative of probands treated for pancreas cancer at karolinska University Hospital and with a positive family history of pancreatic cancer or with a positive anamnesis of an associated genetic syndrome, subjects, with a "genetically" increased risk, referred to us from other swedish centers, subjects referred to us by general partitioners.

Inclusion criteria for the screening All the individuals with a 10 fold higher relative risk in respect to the general population to develop pancreatic cancer will be included in the study. In case of suspected known genetic syndromes, only patients with detected corresponding gene mutations will be enrolled.

Screening modalities All patients fulfilling the inclusion criteria will be enrolled in the clinical study after a specific informed consent. Basically a complete familial and personal anamensis (including the pedegree) and a clinical examination will be obtained from all the patients. A blood sample will be collected into a bio-bank at Karolinska University Hospital. An MR/MRCP with secretin will be performed for all the patients. If the result of the MR are negative (no findings detected) a one year screening, with the same modalities is recommended. Only patients with some anomaly at the MR will undergo EUS with or without FNA and/or MDCT scan. Patients with a positive anamnesis suggestive for a known genetic syndrome will be offered specific genetic tests (BRCA1/2, SPINK1, PRSS1, p16, STK11) and respective genetic counselling.

Target lesions of the screening Due to the low specificity and sensibility of the available technique in order to detect PanIN lesions, the lobulocentric atrophy areas are not considered a target of our screening. Macroscopic pre-neoplastic lesions (IPMN) or pancreatic solid mass are considered the only lesions suitable for detection and screening.

Quality Control Study of MR Based Screening of Individual With Increased Risk for Pancreas Cancer.

Quality Control Study of MR Based Screening of Individual With Increased Risk for Pancreas Cancer

MRI accuracy in detection precancerous pancreatic lesions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pancreatic Cancer Genetic Epidemiology (PACGENE) Study	NCT00526578	Pancreatic Canc...	Questionnaire	18 Years -	M.D. Anderson Cancer Center
Understanding Genetic Incidental Findings in Your Family (UNIFY Study)	NCT02560896	Familial Pancre...		18 Years -	Mayo Clinic
Understanding Genetic Incidental Findings in Your Family (UNIFY Study)	NCT02560896	Familial Pancre...		18 Years -	Mayo Clinic
Quebec Pancreas Cancer Study	NCT04104230	Pancreas Cancer Pancreatic Canc... Pancreas Neopla... Pancreas Cyst Pancreatic Prec... Familial Pancre... Hereditary Canc... Bile Duct Cance... Ampullary Cance... Duodenal Cancer Gallbladder Can...		18 Years -	McGill University Health Centre/Research Institute of the McGill University Health Centre
Cohort Study of Pancreatic Cancer Risk	NCT04247503	Familial Pancre...		18 Years -	Mayo Clinic
DCE MRI in Patients With Pancreatic Cancer	NCT02070705	Familial Pancre... Pancreatic Aden... Pancreatic Intr...	Dynamic Contras... Ferumoxytol	18 Years - 85 Years	OHSU Knight Cancer Institute
Pancreatic Cancer Screening for At-risk Individuals	NCT05006131	Pancreatic Canc...	Screening for p...	18 Years - 90 Years	Beth Israel Deaconess Medical Center
Quebec Pancreas Cancer Study	NCT04104230	Pancreas Cancer Pancreatic Canc... Pancreas Neopla... Pancreas Cyst Pancreatic Prec... Familial Pancre... Hereditary Canc... Bile Duct Cance... Ampullary Cance... Duodenal Cancer Gallbladder Can...		18 Years -	McGill University Health Centre/Research Institute of the McGill University Health Centre
A Study of IMMray™ PanCan-d Test for Early Detection of Pancreatic Cancer in High-risk Groups	NCT03693378	Pancreatic Duct... Familial Pancre... FAMMM - Familia...		-	Immunovia, Inc.
Quality Control Study of MR Based Screening of Individual With Increased Risk for Pancreas Cancer.	NCT02078245	Hereditary Panc... Hereditary Panc...	MRI	18 Years -	Karolinska University Hospital
Cohort Study of Pancreatic Cancer Risk	NCT04247503	Familial Pancre...		18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for familial pancreatic cancer