Molecular Basis for Variations in Hereditary Colorectal Cancer Syndromes
4 other identifiers
observational
2,000
1 country
1
Brief Summary
Objectives:
- 1.To examine the variations in clinical features, survival outcomes, family history, and health behavior among proband patients who are known or suspected to have a hereditary colorectal cancer syndrome
- 2.To compare the clinical features, survival outcomes, and health behavior of the proband vs. his/her family members who may or may not be affected by the hereditary colorectal cancer syndrome
- 3.To explore for correlations between germline genetic variations in both the probands and family members with observed variations in the overall disease phenotype across probands and kindreds, within a given syndrome. Disease phenotype is defined to include: (1) clinicopathologic features including patient demographics and oncologic outcomes; (2) clinical manifestations of disease including the timing, spectrum and severity of CRC and extracolonic cancers. Genetic variations may include the specific codon mutated, the type of mutation and sequence alteration (e.g. nonsense, missense etc), chromosomal/gene copy number changes, and gene polymorphisms.
- 4.To explore for correlations between germline genetic variations in both the probands and family members with observed variations in somatic CRC tumor biology, including tumor pathology and other tumor molecular markers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 22, 2012
CompletedFirst Submitted
Initial submission to the registry
August 8, 2016
CompletedFirst Posted
Study publicly available on registry
August 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2027
April 17, 2026
April 1, 2026
15 years
August 8, 2016
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Variations in Clinical Features Compared Between Proband Group and Family Member Group
Comparison made using 1-way ANOVA or Chi-squared tests.
5 years
Secondary Outcomes (1)
Variations in the Overall Disease Phenotype Between Proband Group and Family Member Group
5 years
Study Arms (3)
Consenting Proband Group
Questionnaires completed at baseline. Blood sample taken at baseline. Follow-up questionnaire completed at least 1 time in 5 years.
Family Members (MDA Registered Patients) Group
Health questionnaire completed at baseline. Blood sample taken at baseline. Follow-up questionnaire completed at least 1 time in 5 years.
Family Members (Not MDA Registered Patients) Group
Health questionnaire completed at baseline. Blood sample taken at baseline. Follow-up questionnaire completed at least 1 time in 5 years.
Interventions
Consenting Proband Group: Participants fill out questionnaires about work, family history, medical history, and health habits at baseline. It should take about 20 minutes to complete the questionnaires. Participants also complete a health and lifestyle questionnaire, which contains 20 questions for men and 22 questions for women. Questionnaire should take about 10 minutes to complete. Follow-up questionnaire at least 1 time in 5 years to update medical, cancer, and family history. Family Members (MDA Registered Patients) Group and Family Members (Not MDA Registered Patients) Group: Participants complete a health questionnaire, which collects information about their personal medical history, demographics (age, race, sex, and so on), and questions about their alcohol and tobacco use at baseline. Questionnaire should take about 20 minutes to complete. Participants complete follow-up questionnaire at least 1 time in 5 years to update their medical, cancer, and family history.
About 2-3 tablespoons blood drawn. Participants may give a saliva sample instead.
Eligibility Criteria
Participants that have, or are suspected to have, a hereditary colorectal cancer syndrome registered at MD Anderson and family members.
You may qualify if:
- Probands who meet the following criteria will be eligible:
- Patient must have or is suspected to have a hereditary CRC syndrome
- Patient must be at least 18 years of age at the time of study registration.
- 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:
- First- or second-degree relative of a registered MDACC patient who has met eligibility criteria for a Proband as defined above.
- Family member must be at least 18 years of age at the time of study registration.
- Family member must have sufficient command of the English language and mental capacity to provide consent
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77330, United States
Related Links
Biospecimen
Blood (about 2-3 tablespoons) drawn.
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi-Qian N. You, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- FAMILY BASED
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2016
First Posted
August 11, 2016
Study Start
May 22, 2012
Primary Completion (Estimated)
May 30, 2027
Study Completion (Estimated)
May 30, 2027
Last Updated
April 17, 2026
Record last verified: 2026-04