Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Obesity

Carcinogenesis

Neoplastic Processes

Pancreatic Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Retrospective chart review and sample analysis of both pathologically confirmed Pancreatic Ductal Adenocarcinoma (PDAC) cases and non-Cancer control cases.

Blood samples, tissue samples and data will be collected from all participants as applicable.

Participants will have 40 mL of blood drawn at baseline/pre-treatment. The study team will aim to have this blood collected at the time of standard of care blood draw if possible.

Blood Sample Collection

At the time of tissue biopsy or surgical resection (if applicable) pancreatic tumor tissue, fat, tissue from site of metastasis, and cyst fluid (if applicable) will be collected.

Tissue Sample Collection

Participants will complete a study questionnaire at baseline that includes medical history, lifestyle, and family history information.

Data Collection

Medical images that are obtained during routine care such as computed tomography (CT) scans, magnetic resonance imaging (MRIs) and ultrasounds will be reviewed by the study team throughout the participant's medical care.

Medical Image Collection

Toni Basinski, MS

Jennifer Permuth, PhD, MS

Mokenge Malafa, MD

Dung-Tsa Chen, PhD

Daniel Jeong, MD, MS

John Koomen, PhD

Paul Stewart, PhD

Jamie Teer, PhD

Ghulam Rasool, PhD

Marilyn Bui, MD, PhD

Kun Jiang, MD, PhD

Magdeline D Martin

Shannon Orr, MD

This study will evaluate obesity-mediated mechanisms of pancreatic carcinogenesis in minority populations.

This observational study will evaluate obesity-mediated mechanisms of pancreatic carcinogenesis in minority populations consisting of adult males or females, 18 years of age or older, who self-report as African American (AA) or Non-Hispanic White (NHW), and present to the gastrointestinal (GI) clinic, surgery, or endoscopy at a participating Florida Pancreas Collaborative (FPC) site or University of Mississippi Medical Center (UMMC) with a clinical suspicion or diagnosis of a pancreatic tumor. This study will also include patients who have been previously recruited as part of the FPC study. Our central hypothesis is that adipose tissue (AT) dysfunction contributes to malignant transformation, therapeutic resistance, and poor survival among obese AA pancreatic ductal adenocarcinoma (PDAC) cases and such dysfunction will be characterized by unique biology. The primary objective of this multi-institutional and multidisciplinary translational study is to identify a molecular and imaging profile unique to paired PDAC tumors and AT from AA and harness biological observations to predict therapeutic response and target novel obesity-mediated mechanisms of PDAC development and progression using in vitro, ex vivo, and in vivo techniques and new combinations of drug agents.

Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations

Investigators will compare gene prevalence, type and expression of genetic mutations and radiomic features in African American participants vs Non-Hispanic White participants

Investigators will compare biological properties of Adipose Tissue dysfunction between African American vs Non-Hispanic White participants.

Investigators will compare the biological interactions of Adipose Tissue and PDAC tumor growth between African American vs. Non-Hispanic White participants to develop new and/or targeted drug combinations.

United States Department of Defense

H. Lee Moffitt Cancer Center and Research Institute

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

Antineoplastic Agents

Dermatologic Agents

Dihematoporphyrin Ether

Trioxsalen

Medlight PDT Balloon will be used once to apply the laser light treatment

Medlight PDT Balloon

Endoscopy will be performed to confirm eligibility, apply photodynamic therapy, assess esophageal condition and effectiveness of the therapy

Endoscopy

Endoscopy with collection of esophageal tissue will be performed at screening to confirm eligibility and at Week 13 (final visit) to assess effectiveness

Endoscopy with biopsy

Resting electrocardiogram will be performed at screening (unless one has been performed within 30 days prior to screening) to measure heart function

Electrocardiogram

A chest X-ray will be performed at screening (unless one has been performed within 90 days prior to screening) to provide several pictures of the chest to rule out any lung abnormalities

Chest x-ray

Blood samples for laboratory tests will be taken to assess the overall condition

Blood collection

Esophageal tissue samples will be collected before the porfimer sodium injection and on four separate occasions after the injection (22-26 hour-, 40-50 hour-, 96-120 hour-intervals, and 13 weeks) to measure concentrations of oligomers in a subgroup of 12 patients.

Tissue sample collection

Photodynamic therapy (PDT) uses a combination of a drug, porfimer sodium, and a light from a non heated laser. The activation of the drug is done by lighting of abnormal areas using a fiber optic device. The fiber optic device is a very fine fiber (like a fishing line) that permits transmission of light. The fiber optic device is inserted into a diffusing balloon device to ensure the good positioning of the fiber optic within the esophagus (food pipe). It is thought that the size and the flexibility of a new diffusing balloon device could improve the safety profile of the photodynamic treatment by reducing the risk of narrowing or closure of the food pipe (esophageal stenosis) sometimes occurring after treatment.

This research study will evaluate the safety and effectiveness of PDT with porfimer sodium using a new diffusing balloon device for light application in the removal of high-grade dysplasia (HGD, precancerous change in the food pipe tissue) in Barrett's esophagus (BE). This study will provide advanced knowledge about phototoxicity (reaction similar to sunburn) and esophageal stenosis, main risks with this therapy. It will involve 75 patients with HGD in BE across North America and Europe and will last between 13 and 16 weeks. In addition, concentrations of porfimer sodium in the esophageal tissue will be analyzed in a subgroup of patients.

Patients with biopsy-confirmed HGD in BE will be evaluated to confirm eligibility. Prior to enrollment, all inclusion and exclusion criteria will be verified. Medical procedures including demographic information, medical/surgical history, concurrent medical conditions, physical exam (including vital signs, body weight, height, and skin color), degree of difficulty in swallowing; electrocardiogram, chest X-ray, clinical laboratory testing, concomitant medication intake and other therapy uses will be collected.

All patients will receive one course of PDT consisting of an intravenous injection of 2.0 mg/kg of porfimer sodium over 3-5 minutes followed by one or two endoscopic laser light applications. The first laser light application will be performed within 40-50 hours using a new diffusing balloon catheter. The second laser light application (without a diffusing balloon catheter) will be performed within 96-120 hours on those areas showing an insufficient response to the first application. Follow-ups (Weeks 4 and 13) will include some or all of the following procedures: physical exam; vital signs evaluation; body weight; endoscopy; skin, degree of difficulty in swallowing and esophageal stenosis assessment; and clinical laboratory check. All patients will be asked general open questions about any occurrence of adverse events, change in concurrent medical conditions, use of adjunctive therapy/procedure, and intake of concomitant medication. All patients will undergo rigorous systematic endoscopic biopsy surveillance at Week 13 (final visit).

Tissue concentration of oligomers (component of porfimer sodium) in normal and abnormal esophageal tissues will be determined in a subgroup of 12 patients. These patients will provide esophageal tissue samples before the porfimer sodium injection and on four separate occasions after the injection (22-26 hour-, 40-50 hour-, 96-120 hour-intervals, and 13 weeks).

All patients will be followed for three months.

Safety of Photodynamic Therapy (PDT) in the Ablation of High-grade Dysplasia (HGD) in Barrett's Esophagus (BE)

Multicenter, Prospective, Open-label, Single-arm Phase IIIb/IV Clinical Study on the Safety of Photodynamic Therapy With Porfimer Sodium for Injection for the Ablation of High-grade Dysplasia in Barrett's Esophagus

Complete ablation of high-grade dysplasia (pre-cancerous tissue) will be evaluated by biopsy

Pinnacle Biologics Inc.

Cysts

Pancreatic Cyst

Neoplasms, Cystic, Mucinous, and Serous

Pancreatic Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Retrospective chart review of pathologically-confirmed Intraductal Papillary Mucinous Neoplasm (IPMN) cases

Blood, tumor tissue samples and data will be collected.

Participants will be asked to donate blood at baseline (+/- 30 days of diagnosis date), 4-6 weeks post-surgery, if applicable, and at the time of follow-up (approximately 1 year and approximately 2 years after baseline).

Blood Sample collection

At the time of tissue biopsy and surgical resection (if applicable), pancreatic tumor tissue, muscle, fat, tissue from site of metastasis, and cyst fluid (if applicable) will be collected.

Participants will be asked to complete questionnaires at baseline and at 1 year and 2 year follow-ups.

Data collection

Arun Khazanchi, MD

Nipun B Merchant, MD, FACS

Jennifer B Permuth, PhD, MS

Daniel Jeong, MD

Jennifer Permuth, PhD

The Florida Pancreas Collaborative wants to partner with individuals who are known to have, or are suspected to have a pancreatic lesion, tumor, cyst, mass, cancer, or pancreatitis and are undergoing diagnosis and treatment at a participating institution. The goals of this project are to build a large database of information obtained from blood, tissue, medical images, surveys and information from routine care to develop noninvasive diagnostic approaches that could be used as decision-making tools to effectively personalize clinical care.

Whole Blood, Plasma, Serum, Tumor tissue from biopsy or surgery, Muscle and fat tissue from surgery, cyst fluid, cytology supernatant, peripheral blood monocular cells (PMBCs)

Using Radiogenomics to Predict Malignant Potential of Intraductal Papillary Mucinous Neoplasms of the Pancreas

Using Radiogenomics to Noninvasively Predict the Malignant Potential of Intraductal Papillary Mucinous Neoplasms (IPMNs) of the Pancreas and Uncover Hidden Biology

Preoperative CT images will be evaluated for a retrospective cohort of at least 254 pathologically-confirmed IPMN cases (approximately 190 malignant characterized by high-grade dysplasia or invasion and approximately 64 benign characterized by low- or moderate-grade dysplasia). 3D-radiomic features will be extracted with the new Quantitative Imaging Decision Support (QIDS)™ platform (Healthmyne, Inc.) and associations will be evaluated with pathology.

Investigators will develop the first prototype preoperative 'omics'-based nomograms to predict IPMN pathology by integrating radiomic features, the MGC, and other covariates. Emphasis will be placed on developing nomograms for individuals whose IPMNs appear to have 'worrisome' radiologic features which are very challenging to manage.

Investigators will conduct the first radiogenomic analyses of IPMNs by evaluating the relationship between radiomic features and tissue and circulating levels of candidate biomarkers.

Overall survival is defined as time from surgery to death from any cause.

Progression free survival is defined as time from surgery to either pancreatic cancer recurrence or death.

National Cancer Institute (NCI)

University of Florida

University of Miami

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Carcinoma in Situ

Breast Carcinoma In Situ

Breast Diseases

Skin Diseases

patients will have tissue procured after a standard of care procedure, a one time blood draw performed, and optional rectal swab

Tissue sample collected following standard of care procedure patient was already scheduled to have

Tissue Sample collection

A one time sample of blood will be collected on day of standard of care procedure

optional rectal swab may be collected on day of standard of care procedure

Rectal Swab

Nicole Simone, MD

Nicole Simone

Tissue will be procured during a standard of care procedure the patient will already be scheduled to undergo. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow Up will only consist of chart review to determine date of recurrence, metastases, and/or death

Prospective Breast Cancer Biospecimen Collection

Collected biospecimens will be analyzed using current laboratory techniques to identify the presence of breast cancer biomarkers such as estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2).

Genomic profile will be based on laboratory analysis of the collected tumor tissue biospecimens to identify how genes interact with the tumor and its environment.

Thomas Jefferson University

Heart and Blood Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Musculoskeletal Diseases

Behaviors and Mental Disorders

Ear, Nose, and Throat Diseases

Diabetes Mellitus

Diabetes Mellitus, Type 2

Overweight

Hyperlipoproteinemias

Hyperlipidemias

Intestinal Diseases

Body Weight

Hypertension

Gastroesophageal Reflux

Weight Loss

Apnea

Sleep Apnea Syndromes

Rheumatic Diseases

Collagen Diseases

Pain

Obesity, Morbid

Musculoskeletal Pain

Somatoform Disorders

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Overnutrition

Nutrition Disorders

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

Deglutition Disorders

Dyslipidemias

Lipid Metabolism Disorders

Muscular Diseases

Neurologic Manifestations

Mental Disorders

Psychotic Disorders

Connective Tissue Diseases

Hormones

Subjects who have had bariatric surgery for obesity - primary and revision. Bariatric surgical procedures include laparoscopic adjustable gastric banding (LAGB), laparoscopic sleeve gastrectomy (LSG), Roux-en-Y gastric bypass (RYGB), bilio-pancreatic diversion (BPD) with or without duodenal switch (BPD-DS).

Subjects who have had endoscopic bariatric therapies for obesity - primary and revision. Bariatric endoscopic procedures include ablation techniques, intragastric balloons, submucosal tunneling procedures (PSAM, GEM, G-POEM), tissue plication platforms (POSE, ROSE), endoluminal sleeves and endoscopic suturing devices (ESG).

Subjects who follow lifestyle modification and/or anti-obesity medications for treatment of obesity with no previous surgical intervention for obesity. Medical therapies include weight loss diets or anti-obesity medications.

Blood Collection

Urine Collection

Tissue (gastric, duodenum, jejunum and ileum - number of biopsies will be 3-4 from each site, ranging in size from 4-7mm) - These samples collected will be extra biopsies that are taken for research purposes during a clinically planned endoscopy for which biopsies are being planned.

Michele B Ryan, MS

Michele B. Ryan, MS

Pichamol Jirapinyo, MD, MPH

The goal of this observational study has the purpose of collecting biological samples from obese patients undergoing evaluation for weight loss by means of medical or endoscopic therapies; and of post bariatric surgery patients presenting with short- and long-term surgical complications. The aim is to enhance the overall understanding of the mechanisms leading to obesity, weight loss, failure to lose weight, and weight regain following treatment. Additional goals are to determine the efficacy of endoscopic and surgical procedures, to identify potential therapeutic targets and disease biomarkers that predict response to therapy.

The prevalence of obesity in the U.S. has reached unacceptably high numbers over the past three decades. Approximately 68% of the American population over the age of 20 is overweight, while 35.7% meet criteria for obesity (CDC). Obesity has become a leading cause of morbidity, mortality and reduced quality of life; and places patients at high risk for several chronic conditions, including: diabetes (DM), hypertension (HTN), hyperlipidemia (HL), sleep apnea, GERD, musculoskeletal disorders and cancer. In addition, obesity imposes a major burden in the American healthcare system, with an estimated annual cost of 147 billion U.S. dollars.

Treatment of obesity is challenging. Preventive measures and medical therapy have not been effective in fighting this epidemic. Diet and exercise, though logical, are hindered by high recidivism and a propensity to regain weight to pre-weight loss levels. Anti-obesity drugs are largely ineffective and limited by safety and side-effects profile. Even bariatric surgery, which provides significant and rapid weight loss, is still followed by substantial weight regain over time. In addition, surgery is associated with a 1% mortality risk, 5-25% 1-year morbidity, and is not readily accessible. Fewer than 1% of eligible obese patients undergo surgery each year. In face of all these challenges, there is an urgent need to better understand the pathophysiology of obesity and the effects of current weight loss interventions. This knowledge will provide a new framework for the development of more effective preventive measures and therapies.

The pathophysiology of obesity is complex. Weight gain results from an energy imbalance; that is, when energy intake is higher than expenditure. In this context, obesity has been attributed to a shift in diet toward increased consumption of energy-dense foods, and to sedentary lifestyle. However, little is known about the physiological mechanisms underlying this trend, which are thought to be regulated by genetic, metabolic and neurobehavioral factors. Even less is understood on how increased adiposity leads to the development of many metabolic disorders, including DM. Surprisingly, these mechanisms can be reversed by bariatric procedures, which in addition to weight loss, have dramatic beneficial effects on metabolic disorders such as DM, HTN, and HL. Therefore, surgery has become an important study tool to enhance our understanding of the pathophysiology of obesity. The collection of biological samples from patients before and after weight loss therapies, including endoscopic and surgical procedures, will provide the basis for a series of studies that will focus on investigating:

* the mechanisms that lead to obesity, particularly appetite and gut regulatory peptides;
* the clinical, physiological, hormonal and metabolic changes imposed by medical, surgical and endoscopic procedures to treat obesity;
* the mechanisms of weight regain following bariatric surgery;
* the mechanism of failure to lose weight following endoscopic or surgical procedures;
* the effects of endoscopic procedures on weight regain following bariatric surgery;
* biomarkers that predict response to medical, endoscopic and surgical therapies;
* biomarkers that predict weight regain or therapeutic failures;
* novel therapeutic targets for the treatment of obesity.

Medical therapies include weight loss diets or anti-obesity medications. Bariatric endoscopic procedures include ablation techniques, intragastric balloons, submucosal tunneling procedures (PSAM, GEM, G-POEM), tissue plication platforms (POSE, ROSE), endoluminal sleeves and endoscopic suturing devices (ESG).

Bariatric surgical procedures include laparoscopic adjustable gastric banding (LAGB), laparoscopic sleeve gastrectomy (LSG), Roux-en-Y gastric bypass (RYGB), bilio-pancreatic diversion (BPD) with or without duodenal switch (BPD-DS).

* Blood (serum will be extracted and stored at -80⁰C),
* Urine (stored at -80⁰C),
* Tissue (gastric, duodenum, jejunum and ileum - number of biopsies will be 3-4 from each site, ranging in size from 4-7mm) - These samples collected will be extra biopsies that are taken for research purposes during a clinically planned endoscopy for which biopsies are being planned.
* Data from medical records will be collected including: age, gender, vitals, weight, bmi, graphs, medical history, surgical history, endoscopy reports, radiology reports, labs, demographics, medications, problem list. Investigators do plan to continue collecting data into the future.

Biological Sample Repository for Gastrointestinal Disorders

MGB and non-MGB investigators may request samples (any of the samples listed in this protocol) from this tissue repository. This request will be made after establishing a formal collaboration with investigators in this protocol. Requests will be made in the form of a written document stating the title and purpose of the project, as well as which experimental procedures will be done with the repository samples. In addition to a written request, collaborators will have to share their approved IRB protocol with the investigators in this repository.

Blood (10 ml) will be collected from the enrolled subjects, serum will be extracted and stored at -80 degrees for up to 10 years.

Urine (5 ml) will be collected via free catch method and stored at -80 degrees C for up to 10 years.

Tissue samples (gastric, duodenum, jejunum and ileum - number of biopsies will be 3-4 from each site, ranging in size from 4-7mm) will be collected during a scheduled endoscopic examination. Biopsy tissue will be collected with a large capacity biopsy forceps and deposited into a conical vial containing a freshly prepared balanced salt solution including a HEPES buffer at the bedside, using 5mL of buffered salt solution per 5-10 mm3 of tissue biopsy, at 4 degrees C. Tissue will be stored at -80⁰C until they are "used up" or for up to 10 years from collection.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations	NCT05687188	Pancreatic Canc...	Blood Sample Co... Tissue Sample C... Data Collection Medical Image C...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Safety of Photodynamic Therapy (PDT) in the Ablation of High-grade Dysplasia (HGD) in Barrett's Esophagus (BE)	NCT01209013	Barrett Esophag...	Medlight PDT Ba... Endoscopy Endoscopy with ... Electrocardiogr... Chest x-ray Blood collectio... Tissue sample c...	18 Years -	Pinnacle Biologics Inc.
Using Radiogenomics to Predict Malignant Potential of Intraductal Papillary Mucinous Neoplasms of the Pancreas	NCT04275557	Pancreatic Canc... Pancreatic Cyst	Blood Sample co... Tissue sample c... Data collection	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Prospective Breast Cancer Biospecimen Collection	NCT04074720	Breast Cancer Invasive Breast... Carcinoma in Si...	Tissue Sample c... Blood Sample Co... Rectal Swab	18 Years -	Thomas Jefferson University
Biological Sample Repository for Gastrointestinal Disorders	NCT05874726	Obesity Obesity, Morbid Obesity, Primar... Gastro-Intestin... Overweight and ... Overweight Overweight or O... Diabetes Type 2 Diabetes Mellit... Diabetes Mellit... Hypertension Hyperlipidemias Sleep Apnea GERD Gastroesophagea... Musculoskeletal... Cancer	Blood Collectio... Urine Collectio... Tissue Sample C...	18 Years -	Brigham and Women's Hospital
Using Radiogenomics to Predict Malignant Potential of Intraductal Papillary Mucinous Neoplasms of the Pancreas	NCT04275557	Pancreatic Canc... Pancreatic Cyst	Blood Sample co... Tissue sample c... Data collection	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Biological Sample Repository for Gastrointestinal Disorders	NCT05874726	Obesity Obesity, Morbid Obesity, Primar... Gastro-Intestin... Overweight and ... Overweight Overweight or O... Diabetes Type 2 Diabetes Mellit... Diabetes Mellit... Hypertension Hyperlipidemias Sleep Apnea GERD Gastroesophagea... Musculoskeletal... Cancer	Blood Collectio... Urine Collectio... Tissue Sample C...	18 Years -	Brigham and Women's Hospital

Spots Global Cancer Trial Database for tissue sample collection