Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT04400903
Eligibility Criteria:
Inclusion Criteria:
* Ability to understand and the willingness to sign an informed consent document
* Own a smartphone that uses Android or Apple iOS operating systems
* Participant must have one of the following:
* Individuals with newly-diagnosed, treatment naive PDAC - all stages (applicable to Stage 1 only), or
* Individuals with at least one of the following family phenotype and age will be included:
* Two or more relatives with PDAC on the same side of the family, where 2 PDAC affected individuals are first-degree related (FDR) AND at least one PDAC-affected individual is an FDR of the subject; Age \>= 50 years OR 10 years before onset in family
* Two affected FDR with PDAC; Age \>= 50 years OR 10 years before onset of an FDR
* Any of BRCA1, BRCA2, PALB2, ATM mutations confirmed pathogenic or likely pathogenic; Age \>= 50 years OR 10 years before onset of an FDR or second-degree relative (SDR)
* Familial atypical multiple mole-melanoma (FAMMM) with confirmed pathogenic or likely pathogenic mutation variants in: p16, CDKN2A; Age \>= 50 years
* Known mutation carrier for STK11 (Peutz-Jeghers syndrome); Age \>= 50 years
* Lynch syndrome (hereditary nonpolyposis colorectal cancer \[HNPCC\]) with confirmed pathogenic or likely pathogenic variants in: MLH1, MSH2, MSH6, PMS2, or EPCAM; Age \>= 50 years OR 10 years before onset of an FDR or SDR
* Hereditary pancreatitis with confirmed PRSS1 pathogenic or likely pathogenic history of pancreatitis; Age \>= 50 years
Exclusion Criteria:
* Any medical conditions that in the opinion of the investigators would compromise participant safety and/or the integrity of the data
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT04400903
Study Brief:
Protocol Section:
NCT04400903