Melanoma Clinical Trial

Pancreatic Cancer Early Detection Consortium

Summary

The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family history of PDAC and/or individuals carrying pathogenic/likely pathogenic germline variants (PGVs) in genes linked to PDAC risk for longitudinal follow up.

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Full Description

The main objective of the PRECEDE Consortium is to build a shared resource to drive research in critical areas necessary for early detection and prevention of PDAC.

The PRECEDE Consortium is an observational prospective cohort study, with single or serial biosample collection (every 6-12 months) in defined high-risk groups.

A standardized procedure for collection and processing of human blood for the PRECEDE Consortium will be applied to all blood samples collected as part of the study. Barcoded samples will be stored at the clinical centers, using the specific labels for the PRECEDE study and corresponding data will be entered into the study database.

Clinical data and outcomes will be obtained from institutional databases or clinical records to correlate patient information with laboratory results from biospecimens obtained for research. Patients will be followed by their attending physician and receive the standard follow-up care after the procedure in which biospecimen was obtained. It is the intent that biospecimens will be made available to all consortium investigators.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Individuals from the following groups who present for clinical evaluation and assessment of PDAC risk at any of the participating sites can be offered participation in the PRECEDE database:

Cohort 1

Individuals without history of PDAC meeting any of the following criteria:

2+ relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject; age 50+ or ≤10 years younger than earliest PDAC in family at time of diagnosis.
2 affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family
BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant AND 1 first or second degree relative with PDAC; age 50+ or 10 years younger than earliest PDAC in family
Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+
Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age 35+
Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis; age 40+

Cohort 2

Individuals without history of PDAC meeting any of the following criteria:

ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history, age 50+
2+ relatives with PDAC on the same side of family, any degree of relation, not meeting other criteria above; age 50+ or 10 years younger than earliest PDAC in family
1 first degree relative with PDAC ≤ age 45; age up to 10 years younger than PDAC diagnosis in family member

Cohort 3 Individual meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2)

Cohort 4 Individuals without history of PDAC presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort.

Cohort 5 Individuals without history of PDAC who are not otherwise engaged in pancreas surveillance at a participating site may be invited to participate in the PRECEDE database and to donate a biosample (e.g. blood, saliva, and/or buccal swab) for discovery studies. This may include relatives of individuals in Cohorts 1-4,6, and the Cyst Cohort.

Cohort 6

Individuals with a personal history of PDAC meeting any of the following criteria:

Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11
Diagnosed ≤ age 45

Cyst Cohort Individuals with a personal history of a pancreatic cystic neoplasm not meeting any criteria for Cohorts 1-3 or 6 (no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk)

Exclusion Criteria:

Individuals not meeting the criteria above.

Study is for people with:

Melanoma

Estimated Enrollment:

8000

Study ID:

NCT04970056

Recruitment Status:

Recruiting

Sponsor:

Arbor Research Collaborative for Health

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There are 23 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States More Info
Anita Menchaca
Contact
[email protected]
James Lin
Principal Investigator
Greg Idos
Principal Investigator
UC San Diego Moores Cancer Center
La Jolla California, 92093, United States More Info
Shirley Sarno
Contact
[email protected]
Andy Lowy
Principal Investigator
Joy Liau
Principal Investigator
Cedars-Sinai Medical Center
Los Angeles California, 90048, United States More Info
Liliana Bancila
Contact
310-423-3872
[email protected]
Srinivas Gaddam
Principal Investigator
Yale University
New Haven Connecticut, 06510, United States More Info
Scott Merenda
Contact
[email protected]
James Farrell
Principal Investigator
Mayo Clinic Jacksonville
Jacksonville Florida, 32224, United States More Info
Guillermo Pradieu
Contact
[email protected]
Yan Bi
Principal Investigator
Michael Wallace
Principal Investigator
University of Miami
Miami Florida, 33136, United States More Info
Elena Cortizas
Contact
[email protected]
Anna Yabloch
Contact
[email protected]
Dan Sussman
Principal Investigator
Nipun Merchant
Principal Investigator
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Jenny Permuth
Principal Investigator
University of Chicago Medicine
Chicago Illinois, 60637, United States More Info
Sonia Kupfer
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Danielle Lynch
Contact
[email protected]
Daniel Chung
Principal Investigator
Umass Memorial Medical Center
Worcester Massachusetts, 01655, United States More Info
Cara Gregoire
Contact
[email protected]
James Lindberg
Principal Investigator
University of Michigan
Ann Arbor Michigan, 48109, United States More Info
Sarah Volk
Contact
[email protected]
Erika Koeppe
Contact
[email protected]
Elena Stoffel
Principal Investigator
Rich Kwon
Principal Investigator
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States More Info
Suzanne Wessling
Contact
[email protected]
Kelsey Klute
Principal Investigator
New York University Langone Health
New York New York, 10016, United States More Info
Jessica Everett
Contact
[email protected]
Jennifer Chun Kim
Contact
[email protected]
Diane Simeone, MD
Principal Investigator
Icahn School of Medicine At Mount Sinai
New York New York, 10029, United States More Info
Arielle Labiner
Contact
[email protected]
Aimee Lucas
Principal Investigator
Columbia University Irving Medical Center
New York New York, 10032, United States More Info
Tiffany Lam
Contact
[email protected]
Fay Kastrinos
Principal Investigator
University of Rochester Medical Center
Rochester New York, 14642, United States More Info
Krystle Bittner
Contact
[email protected]
Darren Carpizo
Principal Investigator
Vivek Kaul
Principal Investigator
Oregon Health & Science University
Portland Oregon, 97239, United States More Info
Dove Keith
Contact
[email protected]
Aaron Grossberg
Principal Investigator
Brett Sheppard
Principal Investigator
Rosie Sears
Principal Investigator
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States More Info
Danny Clay
Contact
[email protected]
Bryson Katona
Principal Investigator
University of Pittsburgh Medical Center (Upmc)
Pittsburgh Pennsylvania, 15232, United States More Info
Beth Dudley
Contact
[email protected]
Randy Brand
Principal Investigator
MD Anderson Center
Houston Texas, 77030, United States More Info
Florencia McAllister
Contact
[email protected]
Florencia McAllister
Principal Investigator
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States More Info
Jo Anson
Contact
[email protected]
Joanne Jeter
Principal Investigator
Inova Schar Cancer Institute
Fairfax Virginia, 22031, United States More Info
Stephanie Van Bebber
Contact
571-472-4724
[email protected]
Raymond Wadlow, MD
Principal Investigator
University of Washington
Seattle Washington, 98195, United States More Info
Lisa Ann Lai
Contact
[email protected]
Teri Brentnall
Principal Investigator
British Columbia Cancer Agency
Vancouver British Columbia, , Canada More Info
Andrew Wong
Contact
[email protected]
Intan Schrader
Principal Investigator
Uhn Mount Sinai Hospital
Toronto Ontario, , Canada More Info
Ayelet Borgida
Contact
[email protected]
Steven Gallinger
Principal Investigator
McGill University Health Centre
Montreal Quebec, , Canada More Info
Adeline Cuggia
Contact
[email protected]
George Zogopoulos
Principal Investigator
Sheba Medical Center
Ramat Gan , , Israel More Info
Maria Raitses
Contact
[email protected]
Talia Golan
Principal Investigator
Ido Laish
Principal Investigator
Eitan Friedman
Principal Investigator
Azienda Ospedaliera Universitaria Integrata Verona
Verona , , Italy More Info
Salvatore Paiella
Contact
[email protected]
Erica Secchettin
Contact
[email protected]
Salvatore Paiella
Principal Investigator
Ramón y Cajal University Hospital
Madrid , , Spain More Info
Julie Earl
Contact
[email protected]
Julie Earl
Principal Investigator
University of Liverpool
Liverpool , , United Kingdom More Info
Annabelle Boughey
Contact
[email protected]
Bill Greenhalf
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Estimated Enrollment:

8000

Study ID:

NCT04970056

Recruitment Status:

Recruiting

Sponsor:


Arbor Research Collaborative for Health

How clear is this clinincal trial information?

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