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Early Cancer Detection Consortium

PRECEDE: The Pancreatic Cancer Early Detection Consortium - Precede

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/03/064152
Enrollment
8000
Registered
2024-03-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C759- Malignant neoplasm of endocrine gland, unspecified

Interventions

Intervention1: NIL: NIL

Sponsors

Arbor research collaborative for Health
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
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 Implementation of standardized protocols that guide healthcare professionals in identifying and managing high risk individuals Development of comprehensive risk models that accurately estimate PDA risk aiding clinicians in personalized risk assessment and guiding clinical decision-makingTimepoint: 10 years

Secondary

MeasureTime frame
Implementation of standardized protocols that guide healthcare professionals in identifying & managing high risk individuals Development of comprehensive risk models that accurately estimate PDA risk aiding clinicians in personalized risk assessmentTimepoint: 10 years

Countries

India

Contacts

Public ContactDr Poorvee Mathur

Max Super Speciality Hospital Saket New Delhi

nikhil@maxhealthcare.com9540946808

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026