Pancreatic Cancer Early Detection Consortium (PRECEDE)

• ClinicalTrials.gov Identifier: NCT04970056
• Recruitment Status: Recruiting
• First Posted: July 21, 2021
• Last Update Posted: April 24, 2024
• Sponsor: Arbor Research Collaborative for Health
• Information provided by (Responsible Party): Arbor Research Collaborative for Health

Tracking Information

• First Submitted Date: April 21, 2021
• First Posted Date: July 21, 2021
• Last Update Posted Date: April 24, 2024
• Actual Study Start Date: September 18, 2020
• Estimated Primary Completion Date: December 31, 2030 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 19, 2021)

Development of PDAC [ Time Frame: Through study completion, an average of 6 years ]

Diagnosis of PDAC

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pancreatic Cancer Early Detection Consortium
• Official Title: Pancreatic Cancer Early Detection Consortium
• Brief 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.

Detailed 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Other
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

A standardized procedure for collection and processing of human blood will be applied to all blood samples collected as part of the study. Barcoded samples will be stored at the clinical centers, and corresponding data will be entered into the study database. Any protocol deviations should also be recorded by each center.

60mL of blood is collected at baseline, 120mL annually, and 60mL at other events.

Eligible individuals who are not seen in person for a clinic visit, who express interest in enrollment after initial contact, will be sent a copy of the IC document and a saliva collection kit by mail. Individuals in Cohort 5 may alternatively submit saliva or buccal swab samples without a clinic visit. Participants will return the signed consent and saliva sample.

• Sampling Method: Non-Probability Sample

Study Population

The study will accrue subjects who present for risk assessment at one of the participating sites based on history of:

• one or more family members with PDAC
• a pathogenic or likely pathogenic germline variant in a gene linked to PDAC risk
• personal history of PDAC with PGV in genes of research interest and/or part of a Familial Pancreatic Cancer kindred

Condition

• Pancreas Cancer
• Pancreas Cyst
• Pancreatic Ductal Adenocarcinoma
• Genetic Predisposition

• Intervention: Not Provided

Study Groups/Cohorts

• 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 FDR 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:

  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
• 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)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 19, 2021): 8000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2030
• Estimated Primary Completion Date: December 31, 2030 (Final data collection date for primary outcome measure)

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:

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 6

Individuals with a personal history of PDAC 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

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Naveen Fawas, BS; 7346654108; naveen.fawaz@arborresearch.org

Contact: John Graff, PhD; 7346654108; john.graff@arborresearch.org

• Listed Location Countries: Canada, Hungary, Iceland, Israel, Italy, Singapore, Spain, Taiwan, United Kingdom, United States

Administrative Information

• NCT Number: NCT04970056
• Other Study ID Numbers: PRECEDE
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Arbor Research Collaborative for Health
• Original Responsible Party: Same as current
• Current Study Sponsor: Arbor Research Collaborative for Health
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Diane Simeone, MD; UC San Diego Moores Cancer Center

• PRS Account: Arbor Research Collaborative for Health
• Verification Date: April 2024