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Pancreatic Cancer Early Detection Consortium (PRECEDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04970056
Recruitment Status : Recruiting
First Posted : July 21, 2021
Last Update Posted : April 24, 2024
Sponsor:
Information provided by (Responsible Party):
Arbor Research Collaborative for Health

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Pancreas Cancer Pancreas Cyst Pancreatic Ductal Adenocarcinoma Genetic Predisposition

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 Design
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Study Type : Observational
Estimated Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Pancreatic Cancer Early Detection Consortium
Actual Study Start Date : September 18, 2020
Estimated Primary Completion Date : December 31, 2030
Estimated Study Completion Date : December 31, 2030

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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)


Outcome Measures
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Primary Outcome Measures :
  1. Development of PDAC [ Time Frame: Through study completion, an average of 6 years ]
    Diagnosis of PDAC


Biospecimen Retention:   Samples With DNA

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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04970056


Contacts
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Contact: Naveen Fawas, BS 7346654108 naveen.fawaz@arborresearch.org
Contact: John Graff, PhD 7346654108 john.graff@arborresearch.org

Locations
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Sponsors and Collaborators
Arbor Research Collaborative for Health
Investigators
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Study Chair: Diane Simeone, MD UC San Diego Moores Cancer Center
More Information
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Responsible Party: Arbor Research Collaborative for Health
ClinicalTrials.gov Identifier: NCT04970056    
Other Study ID Numbers: PRECEDE
First Posted: July 21, 2021    Key Record Dates
Last Update Posted: April 24, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Pancreatic Cyst
Genetic Predisposition to Disease
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
 Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Disease Susceptibility
Disease Attributes
Pathologic Processes
Cysts