Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All patients will undergo a biopsy of their metastatic lesion and have a blood sample taken for molecular screening purposes. No drugs are administered or other interventions are performed.

biopsy

Sherene Loi, MD, PhD

Christos Sotiriou, MD, PhD

Martine Piccart, MD, PhD

This pilot study examines the feasibility and turnaround time of performing and obtaining data from a few key molecular assays. These assays will be performed using different laboratories and technologies from core biopsies taken from patients diagnosed with invasive recurrent or metastatic breast cancer. All results will be uploaded, stored and assessed using the IT Molecular Screening Prototype Platform (MSPP). The MSPP will also be evaluated for ease of use to screen patients for participation in future molecularly defined clinical trials in breast cancer.

This study will accept patients with metastatic/recurrent breast cancer disease. The core biopsies must be taken from a metastatic lesion. To note, these patients can be biopsied at any phase of their metastatic disease (at diagnosis, at progression etc).

* The patient will sign a specific Informed Consent Form (ICF).
* The Investigator will access the MSPP, register the patient and enter basic patient clinical data necessary for the verification of the eligibility criteria.
* The patient will prospectively undergo invasive recurrent or metastatic lesions (1 site easily accessible, such as skin, lymph node or liver) core biopsies including the collection of tumor samples consisting of 2 Formalin Fixed Paraffin Embedded (FFPE) Tissues and 1 (2 recommended) fresh frozen samples embedded in Optimal Cutting Temperature (OCT) compound or stored in RNAlater. One whole blood sample (1x10mL) will also be collected.
* The Investigator will record the biological samples via the MSPP bio-tracking system
* The Investigator is responsible for the immediate dispatch of the samples to the designated central laboratories.
* The assays will be performed at the central laboratories. It should be noted that:

  * Two FFPE samples will be sent to IEO, Milan, Italy. One FFPE sample will be stored. The second FFPE will be used to perform pathological tests. The tests include ER, HER2, Ki67 and PTEN status evaluation by immunohistochemistry (IHC) and FISH (for HER2 only); and of PIK3CA hot spot somatic mutations identification by Sanger DNA sequencing. Unstained sections (10x5µm) and extracted DNA, taken from the FFPE tissue core used for the testing, will be sent to IPG and Sanger, respectively, by the central laboratory.
  * The assays performed at IPG and Sanger will consist of targeted breast cancer genes mutations identification by Ion Proton or HiSeq 2000 DNA sequencing respectively. To note, targeted genes screen will also be coupled with identification of other substitutions, short indels and copy number variants (CNVs).
  * One fresh frozen sample embedded in OCT or stored in RNAlater will be sent to IJBordet, Brussels, Belgium, together with the blood sample, for Affymetrix gene expression profiling and for chromosomal and SNP-analysis using the Cytoscan platform (Affymetrix). The blood sample will be stored.
* The central laboratories will upload the processed data that is generated as a result of the central testing onto the MSPP.
* An alert, by e-mail, will be sent to the Investigator when the central results are available. The Investigator will log on to MSPP and obtain the results.
* The residual biological samples and derivatives will be stored in the BIG study Repository for 15 years or the maximum allowed by local regulations whichever is the shortest. If needed, remaining material will be used for future research as high throughput genetic analysis.

It should be noted that the results obtained from the BIG Molecular Screening Feasibility Study will NOT be used for treatment decision-making. Patients should receive anti-cancer therapy as per the patient's treating physicians decision and in accordance with local institutional guidelines. There is no planned follow-up period. The trial will end after all the information from the 30 accrued patients is entered into the MSPP, within a maximum of 2 months after the recruitment of the last patient.

BIG Molecular Screening Feasibility Study

The BIG Molecular Screening Feasibility Study:Testing the IT Infrastructure and Logistics of a Molecular Screening Program

To evaluate the feasibility of implementing a molecular screening program in order to identify molecular traits in patients that may render them eligible for clinical trials using specific targeted agents.

To test the concordance of targeted breast cancer genes mutations testing by different technologies: Life technologies Ion Proton Sequencer (by IPG) versus Illumina Hiseq 2000 (by Sanger).

To evaluate how many of these patients have potential "actionable" mutations that could theoretically render them eligible for the current active targeted trials using FDA approved drugs (as per www.clinicaltrials.gov).

To determine the proportion of core biopsy specimens obtained from invasive recurrent or metastatic lesions from which adequate amounts of high quality DNA and RNA can be extracted.

To evaluate the technical failure rate (FR) for every single tests (ER, HER2, KI67, PTEN, GEP, CNV and targeted genes screen) using core biopsies.

To evaluate the ability of the MSPP (IT platform) to sort patients to several simulated protocols based on pathological and molecular tests results.

To evaluate the ease of use of the MSPP (IT platform)

Breast International Group

Jules Bordet Institute

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Invitation letter to the screening program with the FIT test

Prior notification to the new entrants, followed by an invitation letter to the screening program with the FIT test

Invitation letter to visit its own GP who will deliver the FIT test

The individuals eligible for the colorectal cancer screening program will receive at home an invitation letter to participate to the program along with a FIT test. The follow-up will be similar to the standard of care, i.e. reminder letters at 5 and 10 months if there is no participation, and reminders if no coloscopy after a positive FIT test

Dispatch of the screening test along the invitation letter to the national colorectal cancer screening program

Dispatch of a notification, one month prior the dispatch of the screening test along the invitation letter. This intervention is among the new entrants to the national program

Sending of a prior notification to the new entrants of the national program

Maurice TANGUY, MD

Myriam GUERBAZ SOMMI, MD

Jean BOTO KEKY, MD

This is a randomized controlled trial comparing the effect on participation rates to colorectal cancer screening between an intervention arm (invitation letter to the screening program including a FIT test with or without prior notification) and a control arm with the standard of care (invitation letter to visit the GP who will deliver the FIT test).

The participation to the national screening program for colorectal cancer in France is low. In order to improve the performances of its organized program, the National Cancer Institute is planning to modify the invitation procedure. This is a pilot project and if an improvement in the program performances is reported, the invitation procedure may be scaled up.

Eligible individuals for colorectal cancer screening will be identified by the Regional Cancer Screening Coordinating Centre and randomized into the intervention or control arms. They will be followed for FIT test submission to the central laboratory (participation to screening). Those who did not send their test will receive reminder letters. Those who had a positive FIT test will be followed up for coloscopy referral, and result of the coloscopy. Comparison of the participation rates to screening program and to coloscopy among those with a positive FIT test will be compared between the two study arms.

This is a three-arm study with a parallel study design

Evaluation of a New Invitation Procedure to the French Organized Colorectal Cancer Screening Program

Evaluation of the Home Delivery of the Screening Kit, and Impact of a Prior Notification Among New Participants to the National Organized Colorectal Cancer Screening Program (Among New Participants Only)

Comparison of the participation rate to the screening program between the intervention and the control arms

Comparison of the referral rates to coloscopy between the intervention and the control arms

Comparison of the participation rates to the screening program between the individuals aged 50-52 of the Intervention1 and the Intervention sub-study arms

International Agency for Research on Cancer

Symptoms and General Pathology

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Syndrome

Adenocarcinoma

Pancreatic Neoplasms

Melanoma

Melanoma, Cutaneous Malignant

Nevus

Dysplastic Nevus Syndrome

Nevus, Pigmented

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevi and Melanomas

Skin Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Pancreatic Cancer

Familial Pancreatic Cancer

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.

Adenoma

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Chrysarobin

Patients will be offered an annual FIT and colonoscopy will be performed if fecal hemoglobin concentration is ≥10µg / g of feces. After performing a colonoscopy the FIT will be sent to the patient:

* After one year if the unscheduled colonoscopy has been incomplete or a lesion requiring endoscopic surveillance has been completely resected.
* After five years if the colonoscopy has evaluated the entire mucosa, it is normal or with lesions that do not require endoscopic surveillance (1-2 non-advanced adenomas).

Annual FIT

First surveillance colonoscopy will be performed in three-year time. If an advanced adenoma or at least three non-advanced adenomas are detected, colonoscopy will be repeated after 3 years. In contrast, if colonoscopy is normal or 1-2 non-advanced adenomas are detected, colonoscopy will be repeated after 5 years.

Endoscopic surveillance.

Joaquín Cubiella, MD PhD

Colorectal cancer (CRC) screening programs have been implemented to reduce the burden of the disease. When an advanced colonic lesions is detected, it is recommended to perform endoscopic surveillance with different intervals between explorations. Although the reduction in CRC incidence, endoscopic surveillance is producing a considerable increase in the number of colonoscopies. However, participation in CRC screening programs based on the fecal immunochemical test (FIT) could be a non inferior alternative to endoscopic surveillance.

Based on this hypothesis, the research group have designed a randomized clinical trial within the population CRC screening programs to compare FIT surveillance to endoscopic surveillance in patients with advanced lesions resected.

Colorectal cancer (CRC) is one of the most common malignancies in western countries. CRC screening programs have been implemented in order to reduce the burden of the disease. Screening programs in Spain are based on the biennial detection of fecal hemoglobin with a fecal immunochemical test (FIT) and a diagnostic colonoscopy if positive. The detection of at least one advanced adenoma or serrated lesion defines a high risk situation for metachronous CRC. This group of patients is recommended to perform endoscopic surveillance with different intervals between explorations. Endoscopic surveillance reduces mortality only 1.7% and increases the number of colonoscopies by 62% with an additional cost of € 68,000 for an increase of 0.9 years of life. Moreover, colonoscopy is a procedure associated with potentially serious side effects.

A recently British study shows that with a cut-off of 10 µg/g, FIT has a higher sensitivity and specificity for CRC with a significant cost reduction compared to colonoscopy surveillance. Additionally, most of the population prefers non-invasive faecal tests rather than colonoscopy.

Based on this evidence, the research group have designed a multicenter, randomized clinical trial to compare the 10 year CRC incidence after resection of advanced colonic lesions detected within CRC screening programs between endoscopic surveillance and participation in CRC screening programs based on FIT.

Apart from this purpose, the investigators will also assess the values and preferences regarding surveillance and risk of CRC. Further, the research group will evaluate the relationship between Mediterranean diet and physical activity with the detection of advanced adenomas and CRC.

Patients will be identified in population CRC secreening programs of Galicia, the Basque Country, the Region of Valencia and Murcia. We will considered individuals aged 50 to 65 years with at least one advanced adenoma (tubulovillous or villous histology, high grade dysplasia or ≥ 10mm), and / or at least three non-advanced adenomas detected and resected completely within the population-based CRC screening program.

Patients will be randomly allocated to perform an annual FIT and colonoscopy if fecal hemoglobin concentration is ≥10µg/g, or to perform endoscopic surveillance. Patients will be also stratified into two groups: ≥5 adenomas or an adenoma ≥20mm and the rest of patients.

Patients will be followed for a period of 10 years.

Polyprev: Study to Compare Fecal Immunochemical Test With Endoscopic Surveillance After Advanced Adenoma Resection in Fecal Immunochemical Test Colorectal Cancer Screening Programs.

Polyprev Study: Randomized, Multicenter, Controlled Trial Comparing Fecal Immunochemical Test With Endoscopic Surveillance After Advanced Adenoma Resection in Fecal Immunochemical Test Colorectal Cancer Screening Programs.

It is the main outcome of the study. Invasive CRC is defined as colonic adenocarcinoma that invades the submucosa. Adenocarcinomas in situ and intramucosal carcinomas will not be considered as invasive CRC.

Interval CRC is defined as the CRC detected between two organized surveillance (FIT or colonoscopy).

The deaths and their cause will be collected: associated with CRC, associated with adverse effects of screening or unrelated.

Advanced colonic lesions will be defined as advanced adenomas (at least 10mm, hairy histology or high grade dysplasia) or advanced serrated lesions (at least 10mm or with dysplasia).

According to the methodology of the information systems of the screening programs, three categories will be defined: non-participation, irregular participation, regular participation.

Adverse effects associated with surveillance are defined as complications that require hospitalization. Those related to the surgical treatment of benign colonic lesions will be included as adverse effects.

Detection of CRC, adenoma and advanced serrated lesion will be collected at 3 years of follow-up.

We will use the International Physical Activity. Questionnaire (IPAQ) to mesure physical activity.

We will use the Mediterranean Lifestyle index (MEDLIFE) to measure overall adherence to the Mediterranean lifestyle.

We will use a survey with vignette questions to evaluate the values and preferences of the subjects regarding surveillance.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
BIG Molecular Screening Feasibility Study	NCT02094742	Metastatic Brea...	biopsy	18 Years -	Jules Bordet Institute
Evaluation of a New Invitation Procedure to the French Organized Colorectal Cancer Screening Program	NCT05589675	Colorectal Canc...	Dispatch of the... Sending of a pr...	50 Years - 74 Years	International Agency for Research on Cancer
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.
Polyprev: Study to Compare Fecal Immunochemical Test With Endoscopic Surveillance After Advanced Adenoma Resection in Fecal Immunochemical Test Colorectal Cancer Screening Programs.	NCT04967183	Colorectal Canc...	Annual FIT Endoscopic surv...	50 Years - 65 Years	Fundacin Biomedica Galicia Sur

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