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Trial record 6 of 391 for:    colorectal | Recruiting Studies | United States

Young-Onset Microsatellite-Stable Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02863107
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this laboratory research study is to learn more about genetic factors that may influence the risk for developing colorectal cancer at a young age.

Condition or disease Intervention/treatment
Colon Cancer Rectal Cancer Behavioral: Questionnaires Procedure: Blood Draw

Detailed Description:


If you agree to take part in this study, you will fill out some questionnaires about your work, family history, medical history, and health habits. If you have already answered these questionnaires when you were registered as a patient at MD Anderson, the study staff will give you a copy and review your answers with you for any updates or if you have any questions. It should take about 10-15 minutes to complete the questionnaires.

You will complete another questionnaire about your experience as a cancer survivor. These questions will be about your quality of life, well-being, concerns you may have, as well as the types of health care and follow-up care you are receiving. It should take about 20-25 minutes to complete this questionnaire.

You may be given the questionnaires electronically on REDcap (a secure, web-based application used to collect data for research studies that you can access from your phone, tablet, or computer), over the phone (either with a member of the study staff asking questions or by using an electronic response system called IVR), at home through the mail, or in person by a member of the research staff at one of your MD Anderson visits.

If mailed, a postage-paid return envelope will be provided for the return of the questionnaire.

Blood or Saliva Collection:

Blood (about 2 tablespoons) will be collected 1 time. If possible, this blood will be drawn at a scheduled routine blood draw, so that an additional needle stick is not required. However, if it cannot be scheduled during a planned blood draw, an additional needle stick will be needed.

If you are unwilling or unable to give a blood sample, a saliva sample will be collected instead. While you are at MD Anderson, a saliva collection kit will be given to you.

Length of Study:

If you are an active patient who has undergone treatment at MD Anderson Cancer Center within the past year, you will receive additional questionnaires 6 and 12 months after you have completed treatment, and then every year for up to 5 years.

This is an investigational study.

Up to 1,000 patients and family members will take part in this study. All will be enrolled at MD Anderson.

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Young-Onset Microsatellite-Stable Colorectal Cancer
Actual Study Start Date : June 2012
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Colorectal Cancer
Questionnaires completed at registration in study or at baseline, and once a year for 5 years. Blood (about 2 tablespoons) collected 1 time.
Behavioral: Questionnaires
Participants complete questionnaires about work, family history, medical history, and health habits. Questions are about quality of life, well-being, concerns they may have, as well as the types of health care and follow-up care they are receiving.
Other Name: Surveys
Procedure: Blood Draw
About 2 tablespoons blood collected 1 time.

Primary Outcome Measures :
  1. Genomes of Participants Diagnosed with Young-Onset Microsatellite Stable (MSS) Colorectal Cancers (CRCs) vs. Later Onset Microsatellite Stable (MSS) Colorectal Cancers (CRCs) [ Time Frame: 5 years ]
    Comparisons between the young and the older cohorts performed.

Secondary Outcome Measures :
  1. Polymorphism Variants and/or New Mutations of Participants Diagnosed with Young-Onset Microsatellite Stable (MSS) Colorectal Cancers (CRCs) vs. Later Onset Microsatellite Stable (MSS) Colorectal Cancers (CRCs) [ Time Frame: 5 years ]
    Test for differences between the young-onset vs. later-onset cohorts for each polymorphism variant or mutation genotype.

Biospecimen Retention:   Samples With DNA
Participants have a one-time collection of whole blood (up to 40cc).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Colorectal cancer participant at MD Anderson.

Inclusion Criteria:

  1. MDACC patients who have adenocarcinoma of the colon or rectum, diagnosed between ages 18 through 50 (young-onset), or diagnosed at age 65 or older (later-onset), who had microsatellite status testing (by either immunohistochemistry or PCR testing or germline testing or a combination thereof).
  2. Patient must have sufficient command of the English language and mental capacity to provide consent.

Family members who meet the following criteria will be eligible:

  1. Be a parent, sibling or child (first degree blood relative) of a registered MDACC patient meeting eligibility criteria above.
  2. Have sufficient command of the English language and mental capacity to provide consent.
  3. Family member must be at least 18 years of age at the time of study registration.

Exclusion Criteria:

  1. Patient must NOT have known or suspected clinical diagnosis of a hereditary polyposis syndrome including hereditary adenomatous polyposis syndromes, hereditary nonadenomatous polyposis syndromes, and hereditary nonpolyposis syndromes.
  2. Patient's adenocarcinoma must NOT be microsatellite high or unstable (defined by loss of expression of at least one DNA mismatch repair genes MLH1, MSH2, MSH6, PMS2 by immunohistochemistry, and/or >30% allelic shift by microsatellite PCR testing).
  3. Patient must NOT have a known germline mutation in DNA mismatch repair genes (MLH1, MSH2, MSH6, PMS2), APC, or MYH genes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863107

Contact: Yi-Qian N. You, MD 713-792-6940

United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Yi-Qian N. You, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02863107     History of Changes
Other Study ID Numbers: PA11-0566
2015-00051016-Y1 ( Other Grant/Funding Number: Y. Nancy You, MD MHSc, Young Microsatellite stable colorectal cancer, G.S. Hogan GI cancer Research Grant, MD Anderson )
2016-00051406 ( Other Grant/Funding Number: Eduardo Vilar-Sanchez, MD, PhD, Germline Precision Prevention in Adolescents )
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by M.D. Anderson Cancer Center:
Colon Cancer
Rectal Cancer
Blood draw

Additional relevant MeSH terms:
Colorectal Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases