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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 : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date August 8, 2016
First Posted Date August 11, 2016
Last Update Posted Date May 29, 2019
Actual Study Start Date June 2012
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 15, 2016)
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.
Original Primary Outcome Measures
 (submitted: August 8, 2016)
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 by using the Wilcoxon rank-sum test for continuous variables and Chi-squared or Fisher's exact tests for categorical variables as appropriate.
Change History Complete list of historical versions of study NCT02863107 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 15, 2016)
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.
Original Secondary Outcome Measures
 (submitted: August 8, 2016)
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 ]
Chi-squared test used to test for differences between the young-onset vs. later-onset cohorts for each polymorphism variant or mutation genotype.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Young-Onset Microsatellite-Stable Colorectal Cancer
Official Title Young-Onset Microsatellite-Stable Colorectal Cancer
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.
Detailed Description

Questionnaires:

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Participants have a one-time collection of whole blood (up to 40cc).
Sampling Method Non-Probability Sample
Study Population Colorectal cancer participant at MD Anderson.
Condition
  • Colon Cancer
  • Rectal Cancer
Intervention
  • 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.
Study Groups/Cohorts 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.
Interventions:
  • Behavioral: Questionnaires
  • Procedure: Blood Draw
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 8, 2016)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2023
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Yi-Qian N. You, MD 713-792-6940 YNYou@mdanderson.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02863107
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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor M.D. Anderson Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Yi-Qian N. You, MD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date May 2019