Early Cancer Detection Consortium

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Individuals from the following groups who present for clinical evaluation and assessment of PDAC risk at Max Super speciality hospital 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 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

None

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development and establishment of evidencebased practice standards for genetic testing and surveillance in individuals with a family history of PDA and carriers of gene mutations linked to PDA risk <br/ ><br>Implementation of standardized protocols that guide healthcare professionals in identifying and managing high risk individuals <br/ ><br>Development of comprehensive risk models that accurately estimate PDA risk aiding clinicians in personalized risk assessment and guiding clinical decision-makingTimepoint: 10 years

Secondary Outcome Measures

Name	Time	Method
Implementation of standardized protocols that guide healthcare professionals in identifying & managing high risk individuals <br/ ><br>Development of comprehensive risk models that accurately estimate PDA risk aiding clinicians in personalized risk assessmentTimepoint: 10 years