Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT02863172

Conditions

Hereditary Colorectal Cancer Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Questionnaires

Blood Draw/Saliva Sample

Study Details

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

Conditions

Hereditary Colorectal Cancer Syndrome

Study ID

NCT02863172

Start date

May 22, 2012

Status verified date

Apr, 2026

Completion date

May 30, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Probands who meet the following criteria will be eligible:

1. Patient must have or is suspected to have a hereditary CRC syndrome
2. Patient must be at least 18 years of age at the time of study registration.
3. 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. First- or second-degree relative of a registered MDACC patient who has met eligibility criteria for a Proband as defined above.
2. Family member must be at least 18 years of age at the time of study registration.
3. Family member must have sufficient command of the English language and mental capacity to provide consent

Exclusion Criteria:

N/A

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Questionnaires

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.

Blood Draw/Saliva Sample

About 2-3 tablespoons blood drawn. Participants may give a saliva sample instead.

Primary outcome measure

  • Variations in Clinical Features Compared Between Proband Group and Family Member Group [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Yi-Qian N. You, MD

713-792-6940YNYou@mdanderson.org

Locations

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77330

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

  • Hereditary colorectal cancer syndrome
  • Questionnaires
  • Surveys
  • Blood sample
  • Saliva sample

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-17.