NCT02863107

Young-Onset Colorectal Cancer

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 818 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study investigates the genetic factors that may influence the risk of developing colorectal cancer at a young age. Finding genetic markers for colorectal may help identify patients who are at risk of colorectal cancer. Studying individuals and families at high risk of cancer may help identify cancer genes and other persons at risk.

Detailed description

PRIMARY OBJECTIVES: I. To define the clinical phenotype of young-onset versus (vs.) later onset colorectal cancer (CRC), including clinicopathologic characteristics, tumor molecular markers, family history, and associated lifestyle/environmental factors. II. To examine germline genetic alterations in patients with young-onset (diagnosed between age 18 and 50), CRC and those of their first-degree relatives, in comparison to those in patients with later-onset (diagnosed at age 51 or older) CRC. III. To determine the frequency of the mutations and pattern of inheritance of the mutations identified above in this patient population. IV. To correlate molecular findings to clinical endpoints of survival and disease recurrence and/or progression in patients with young-onset vs. later-onset CRC. V. To compare the treatments received by patients with young-onset vs. later-onset CRC and their subsequent survivorship experiences. OUTLINE: PATIENTS: Patients complete questionnaires over 30-50 minutes about work, family history, medical history, health habits, and experience as a cancer survivor (quality of life, well-being, concerns, types of health care, and follow-up care received). Active patients, who have undergone treatment at MD Anderson Cancer Center within the past year, complete additional questionnaires at enrollment, 6 months, 12 months after treatment completion, and then every years for up to 6 years. Also, active patients who are consented to the study more than 5 years from surgery, they may complete the survivorship questionnaire once. Patients medical records are also reviewed. FAMILY MEMBERS: Participants complete questionnaires over 10-15 minutes. Participants also undergo collection of blood or saliva samples once.

Conditions

• Colon Adenocarcinoma
• Colorectal Carcinoma
• Rectal Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood or saliva samples
OTHER	Medical Chart Review	Review of medical charts
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Complete questionnaires

Timeline

• Start date: 2012-06-07
• Primary completion: 2030-08-31
• Completion: 2030-08-31
• First posted: 2016-08-11
• Last updated: 2026-04-16

Locations

5 sites across 1 country: United States