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Trial record 4 of 368 for:    colorectal | Recruiting | United States

Young-Onset Microsatellite-Stable Colorectal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT02863107
First received: August 8, 2016
Last updated: August 15, 2016
Last verified: August 2016
  Purpose
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 Intervention
Colon Cancer
Rectal Cancer
Behavioral: Questionnaires
Procedure: Blood Draw

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Young-Onset Microsatellite-Stable Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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:
  • 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).

Estimated Enrollment: 1000
Study Start Date: June 2012
Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Detailed Description:

Questionnaires:

If participant agrees to take part in this study, they will fill out some questionnaires about their work, family history, medical history, and health habits. It should take about 10-15 minutes to complete the questionnaires.

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

All of the questionnaires will either be given to participant by the research staff at one of their MD Anderson visits or they will be mailed to participant's home with a postage-paid return envelope to mail them back to the study staff.

Blood or Saliva Collection:

Blood (about 2 tablespoons) will be collected 1 time.

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

Length of Study:

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

If participant is a patient who has completed treatment over 1 year ago, or are a patient, they will also complete a questionnaire at least once 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.

  Eligibility

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.
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.

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02863107

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

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

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 )
Study First Received: August 8, 2016
Last Updated: August 15, 2016

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

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

ClinicalTrials.gov processed this record on May 23, 2017