Young-Onset Microsatellite-Stable Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02863107|
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : August 21, 2018
|Condition or disease||Intervention/treatment|
|Colon Cancer Rectal Cancer||Behavioral: Questionnaires Procedure: Blood Draw|
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|
|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|
Questionnaires completed at registration in study or at baseline, and once a year for 5 years. Blood (about 2 tablespoons) collected 1 time.
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.
- 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.
- 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
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|
|Principal Investigator:||Yi-Qian N. You, MD||M.D. Anderson Cancer Center|