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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT04751435
Eligibility Criteria:
Inclusion Criteria:
Phase 1
* Age ≥ 18 years as per self-report
* Current or previous diagnosis of breast, ovarian, pancreatic, or prostate cancer as per self-report
* Self-identification as Black, Latino, and/or neither Black nor Latino (i.e.,non-Latino, Non black)
* Fluency in English, Haitian Creole, or Spanish as per self-report (for Spanish, we will attempt to recruit a cohort representing a variety of regions where Spanish is spoken, as informed by current data from participating sites, to achieve neutrality in the language) Fluency is defined as an answer of "well" or "very well" on the screening questions for spoken and reading ability.
Phase 2:
* Age ≥ 18 years as per the medical record
* Current or previous diagnosis of breast, colorectal, ovarian, pancreatic, or prostate cancer meeting at least one of the applicable criteria for the cancer type as per the medical record and/or clinician referral:
* Breast cancer criteria:
* any diagnosis age 65 or younger;
* diagnosis of triple negative breast cancer at any age;
* multiple primary breast cancers at any age;
* under consideration for PARP therapy;
* any family history (1st, 2nd, or 3rd degree relatives) of ovarian or pancreas cancer, or 1 relative with breast cancer who meets the above criteria, or 2 relatives with breast cancer at any age; or clinician discretion)
* Colorectal cancer criteria:
* any diagnosis age 50 and below;
* mismatch repair deficient colorectal cancer;
* colorectal cancer at any age with an additional Lynch syndromerelated primary cancer at any age;
* colorectal cancer at any age with a 1st or 2nd degree relative with colorectal cancer at/before age 50;
* colorectal cancer at any age with 2 or more 1st or 2nd degree relatives with a Lynch syndrome-related cancer at any age
* Ovarian cancer criteria:
° invasive ovarian cancer
* Pancreatic cancer criteria:
° pancreatic adenocarcinoma
* Prostate cancer criteria:
* castrate-resistant, metastatic prostate cancer;
* high-risk prostate cancer (pending pathology definition)
* Fluency in English, Haitian Creole, or Spanish as per self-report. Fluency is defined as an answer of "well" or "very well" on the screening questions for spoken ability
* No prior cancer genetic counseling or germline testing for cancer risk as per self-report clinician's note, and/or no clinical documentation
Exclusion Criteria:
Phase 1:
* Individuals of impaired decision-making capacity as per a clinician's or consenting professional's judgment.
* Subjects who indicate level of fluency as "not at all" or "not well".
Phase 2:
* Individuals of impaired decision-making capacity as per a clinician's or consenting professional's judgment.
* Subjects who indicate level of fluency as "not at all" or "not well".
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04751435
Study Brief:
Protocol Section:
NCT04751435