Young-Onset Colorectal Cancer

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02863107
Study type	Observational
Source	M.D. Anderson Cancer Center
Contact
Status	Active, not recruiting
Phase
Start date	June 7, 2012
Completion date	August 31, 2030

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.