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 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT05661292
Eligibility Criteria:
Inclusion Criteria:
* Asymptomatic subjects between 50 and 75 years of age-eligible for CRC screening with or without registry at the institute.
Note: concerning symptoms of CRC diagnosis will not be admitted: fresh blood in the stool, black stools, unexplained weight loss (\>10% of usual body weight). Concerning symptoms of Functional Gastrointestinal Disorder (FGID) will be permitted: loss of appetite, diarrhea, constipation, abdominal pain or discomfort.
* Subjects who give their informed consent.
* Subjects who have completed the vaccination schedule against the SARS CoV-2 virus with any of the vaccines approved in Mexico, at least 4 weeks before the colonoscopy.
Exclusion Criteria:
* Personal history of any type of cancer, except basal cell carcinoma or cervical cancer in situ.
* Personal history of colon polyps.
* Personal history of abdominal or pelvic radiation due to previous cancer.
* Relatives with familial adenomatous polyposis (FAP) or hereditary non-polyposis CRC.
* Inflammatory bowel disease (IBD).
* High anesthetic risk (ASA greater than 3 of the classification of the American Society of Anesthesiology).
* Any medical condition that limits life expectancy at the discretion of the investigator.
* Charlson index \> 4.
* Presence of anemia in the last year according to the WHO definition: women \<12 g/dl, men \<13 g/dl.
* Previous colectomy.
* Colonoscopy in the previous 5 years.
* Sigmoidoscopy in the previous 3 years.
* A fecal occult blood test in the past year.
* CT colonography in the previous 10 years.
* Clinical data suggestive of CRC such as hematochezia, melena, weight loss greater than 10% of usual body weight in a 6 months period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT05661292
Study Brief:
Protocol Section:
NCT05661292