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:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT02243267
Eligibility Criteria:
Inclusion Criteria:
5.2 General Eligibility Criteria 5.2.1 Overall Inclusion
1. Adults 18 years of age or older
2. Willing to sign informed consent.
3. Able to tolerate removal of up to 50 ml of blood
5.2.2 Overall Exclusion Criteria
1. Pregnant, lactating
2. Unable to understand English
3. Known HIV/AIDS or Hepatitis C
5.3 Disease or Control Specific Eligibility Criteria 5.3.1 Unaffected Healthy Individuals (Healthy Controls)
1. No prior colorectal neoplasia
2. Undergoing colonoscopy in the next 3-4 months OR had an endoscopically normal colonoscopy within the previous 6 months.
3. Not prepped for colonoscopy at the time of blood draw
4. No personal history of colorectal cancer
5. No personal history of other cancers in the last 5 years (except basal/squamous skin lesions)
5.3.2 Prior non-invasive colorectal neoplasia (Adenoma surveillance)
1. Personal history of one or more adenomas or sessile serrated polyps in colon
2. Undergoing colonoscopy in the next 3-4 months
3. Not prepped for colonoscopy at the time of blood draw
4. No personal history of colorectal cancer
5. No personal history of other cancers in the last 5 years (except basal/squamous skin lesions)
5.3.3 New Diagnosis of Colon Adenocarcinoma (untreated, new colon CA)
1. Newly diagnosed colon adenocarcinoma, any stage
2. No treatment received yet
3. Not prepped for colonoscopy or surgery at the time of blood draw
5.3.4 New Diagnosis of Rectal Adenocarcinoma (untreated, new rectal CA)
1. Newly diagnosed rectal adenocarcinoma, any stage
2. No treatment received yet
3. Not prepped for colonoscopy or surgery at the time of blood draw
5.3.5 Colorectal Cancer (less than 5 years ago) (current/recent CRC)
1. Personal history of colorectal adenocarcinoma within the last 5 years
2. Not prepped for colonoscopy at the time of blood draw
3. No personal history of other cancers in the last 5 years (except basal/squamous skin lesions)
5.3.6 Colorectal Cancer (greater than 5 years ago)(remote history of colorectal cancer)
1. Personal history of colorectal adenocarcinoma greater than 5 years ago
2. Not prepped for colonoscopy at the time of blood draw
5.3.7 Hereditary Cancer syndrome (confirmed or suspected) (genetic risk of colorectal cancer)
1. Personal or family history which meets clinical criteria for genetic evaluation for a hereditary cancer syndrome
2. Not prepped for colonoscopy at the time of blood draw
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02243267
Study Brief:
Protocol Section:
NCT02243267