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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT01102556
Eligibility Criteria:
Inclusion Criteria:
* Individuals who have been diagnosed with pancreatic cancer or suspicion of pancreatic cancer, a pre-neoplastic lesion in the pancreas who are 18 years or older
* Individuals identified to be high risk for developing pancreatic cancer who are 18 years or older based on the following criteria:
* The modified clinical Bethesda criteria for hereditary nonpolyposis colorectal cancer (HNPCC), which are as follows: individuals with 2 HNPCC-associated cancers (colon, endometrial, small bowel, hepatobiliary, pancreatic, genitourinary, or gastric), including synchronous or metachronous lesions; individuals with colon cancer and a first degree relative with an HNPCC-associated tumor and/or colonic adenoma (1 cancer diagnosed at age \<45 years and the adenoma diagnosed at age \<40 years); individuals with colon or endometrial cancer diagnosed at \<50 years; individuals with right-sided colon cancer having an undifferentiated pattern (solid/cribiform) or signet cell histopathology diagnosed at \<45 years; or individuals with adenomas diagnosed at \<40 years.
* Those with a personal or family history of other pancreatic cancer associated syndromes including: Peutz-Jeghers syndrome, familial pancreatic cancer syndrome, familial breast cancer syndrome associated with BReast CAncer genes 1 or 2 (BRCA-2 or BRCA-1), hereditary pancreatitis, familial atypical multiple mole melanoma, and others.
* Patients in a family with a genetically determined cancer predisposition syndrome.
* Patients with a personal history of a gastrointestinal malignancy at age \<45 years.
* Individuals at high-risk based on personal or family history, but not related to a known pancreatic cancer syndrome include the following: those with a personal history of pancreatic cancer, or a pre-neoplastic pancreatic lesion; those with a family history of two or more individuals with cancer, at least one of which is reported to be a gastrointestinal malignancy; a history of early onset (\<50 years) gastrointestinal cancer in the individual or a family member; a history of multiple primary cancers, at least one of which is a gastrointestinal primary, or a family member of an individual meeting this criterion.
Exclusion Criteria:
* Inability to obtain informed consent for study enrollment.
* Under the age of 18 years old.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01102556
Study Brief:
Protocol Section:
NCT01102556