Molecular Basis for Variations in Hereditary Colorectal Cancer Syndromes

Conditions

• Hereditary Colorectal Cancer Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Questionnaires — BEHAVIORAL
  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 — PROCEDURE
  About 2-3 tablespoons blood drawn. Participants may give a saliva sample instead.

Study Details

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

Key Dates

Start date

May 22, 2012

Status verified

Apr 2026

Primary completion

May 30, 2027

Completion

May 30, 2027

Study Design

Enrollment

2,000 participants (estimated)

Arms

• Arm: Consenting Proband Group
  Questionnaires completed at baseline. Blood sample taken at baseline. Follow-up questionnaire completed at least 1 time in 5 years.
• Arm: 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.
• Arm: 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.

Primary Outcome Measure

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

Central Contacts

• Yi-Qian N. You, MD
  713-792-6940
  [email protected]

Locations (1)

Find similar trials in Houston, TX