Research on early detection of pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Pancreatic Cancer Early Detection Consortium aims to investigate early detection and prevention strategies for pancreatic ductal adenocarcinoma (PDAC) by creating a multisite cohort of individuals at high risk due to family history or genetic predisposition. Participants will undergo regular biosample collection and clinical evaluations to gather data on PDAC risk factors. The study will standardize blood sample collection and processing, with a focus on correlating clinical data with laboratory results over time. This observational study seeks to build a comprehensive resource for ongoing research in this critical area.

Why it matters

Who can join: the full rules

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:

1. 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. 2 affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family
3. 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
4. Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+
5. Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age 35+
6. 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:

1. ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history, age 50+
2. 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
3. 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 6a

Individuals diagnosed with PDAC or pancreatic high-grade dysplasia after enrollment in PRECEDE meeting any of the following criteria:

1. Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
2. 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

Cohort 6b

Individuals with a personal history of PDAC or pancreatic high-grade dysplasia meeting any of the following criteria:

1. Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
2. 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
3. Diagnosed ≤ age 45

Cohort 6c Individuals with newly diagnosed early stage (stage I or stage II) PDAC seen at a PRECEDE site that do not meet the criteria for 6a or 6b.

Cohort 6d Individuals with PDAC seen at a PRECEDE site that do not meet the criteria for 6a, 6b, or 6c.

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.

Where it's running

• Honor Health Research Institute
  Scottsdale, Arizona, United States Recruiting
• Providence Health and Services
  Burbank, California, United States Recruiting
• City of Hope
  Duarte, California, United States Recruiting
• UC San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• UCLA Health
  Los Angeles, California, United States Recruiting

+12 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Naveen Fawas, BS
• Email: naveen.fawaz@arborresearch.org
• Phone: 7346654108

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.