Validation of Advanced Colorectal Neoplasm Risk Categories in a Prospective Cohort in Mexico

Launched by INSTITUTO NACIONAL DE CIENCIAS MEDICAS Y NUTRICION SALVADOR ZUBIRAN · Dec 13, 2022

Keywords

ClinConnect Summary

This clinical trial is looking to improve colorectal cancer screening in Mexico by developing a tool that can help identify individuals at the highest risk for advanced colorectal neoplasia (ACN), which can lead to cancer. Currently, there is no national screening program in Mexico, and many people do not have access to colonoscopies. The study aims to create a risk calculator that is tailored for the Mexican population, allowing healthcare providers to focus screening efforts on those who need it most, rather than screening everyone.

To participate in the trial, individuals must be asymptomatic adults aged 50 to 75 who are eligible for colorectal cancer screening. They must also have completed their COVID-19 vaccination at least four weeks before the colonoscopy. However, those with certain medical histories, such as previous cancers or significant gastrointestinal issues, cannot participate. If you join the study, you can expect to undergo a colonoscopy, which is a procedure that allows doctors to examine the inside of the colon for any abnormalities. This research is important as it aims to create a more effective and efficient approach to colorectal cancer screening in Mexico, ultimately helping to save lives.

Gender

ALL

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.

Trial Officials