PRECEDE: Pancreatic Cancer Early Detection Consortium

Sponsor
Arbor Research Collaborative for Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT04970056
Collaborator
(none)
8,000
Enrollment
28
Locations
123.4
Anticipated Duration (Months)
285.7
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

Study Description

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 Design

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

Arms and Interventions

ArmIntervention/Treatment
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 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 above after collection of full family history and/or germline testing

Cohort 5

Individuals 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 and individuals with personal history of PDAC.

Cohort 6

Individuals with pancreatic cyst(s), that are ineligible for Cohorts 1-5.

Outcome Measures

Primary Outcome Measures

  1. Development of PDAC [Through study completion, an average of 6 years]

    Diagnosis of PDAC

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

  3. 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 above after collection of full family history and/or germline testing

Cohort 5 Individuals 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 and individuals with personal history of PDAC.

Cohort 6 Individuals with pancreatic cyst(s), that are ineligible for Cohorts 1-5.

Exclusion Criteria:
  • Individuals not meeting the criteria above.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1UC San Diego Moores Cancer CenterLa JollaCaliforniaUnited States92093
2Cedars-Sinai Medical CenterLos AngelesCaliforniaUnited States90048
3Yale UniversityNew HavenConnecticutUnited States06510
4Mayo Clinic JacksonvilleJacksonvilleFloridaUnited States32224
5University of MiamiMiamiFloridaUnited States33136
6Moffitt Cancer CenterTampaFloridaUnited States33612
7University of Chicago MedicineChicagoIllinoisUnited States60637
8Massachusetts General HospitalBostonMassachusettsUnited States02114
9Umass Memorial Medical CenterWorcesterMassachusettsUnited States01655
10University of MichiganAnn ArborMichiganUnited States48109
11University of Nebraska Medical CenterOmahaNebraskaUnited States68198
12New York University Langone HealthNew YorkNew YorkUnited States10016
13Icahn School of Medicine At Mount SinaiNew YorkNew YorkUnited States10029
14Columbia University Irving Medical CenterNew YorkNew YorkUnited States10032
15University of Rochester Medical CenterRochesterNew YorkUnited States14642
16Oregon Health & Science UniversityPortlandOregonUnited States97239
17University of PennsylvaniaPhiladelphiaPennsylvaniaUnited States19104
18University of Pittsburgh Medical Center (Upmc)PittsburghPennsylvaniaUnited States15232
19MD Anderson CenterHoustonTexasUnited States77030
20Huntsman Cancer InstituteSalt Lake CityUtahUnited States84112
21Inova Schar Cancer InstituteFairfaxVirginiaUnited States22031
22University of WashingtonSeattleWashingtonUnited States98195
23British Columbia Cancer AgencyVancouverBritish ColumbiaCanada
24Uhn Mount Sinai HospitalTorontoOntarioCanada
25McGill University Health CentreMontrealQuebecCanada
26Sheba Medical CenterRamat GanIsrael
27Azienda Ospedaliera Universitaria Integrata VeronaVeronaItaly
28Ramón y Cajal University HospitalMadridSpain

Sponsors and Collaborators

  • Arbor Research Collaborative for Health

Investigators

  • Study Chair: Diane Simeone, MD, New York University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Arbor Research Collaborative for Health
ClinicalTrials.gov Identifier:
NCT04970056
Other Study ID Numbers:
  • PRECEDE
First Posted:
Jul 21, 2021
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022