Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 26 of 484 for:    colon cancer | ( Map: Texas, United States )

Molecular Basis for Variations in Hereditary Colorectal Cancer Syndromes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02863172
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

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

Condition or disease Intervention/treatment
Hereditary Colorectal Cancer Syndrome Behavioral: Questionnaires Procedure: Blood Draw/Saliva Sample

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Molecular Basis for Variations in Hereditary Colorectal Cancer Syndromes
Actual Study Start Date : May 2012
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Consenting Proband Group
Questionnaires completed at baseline. Blood sample taken at baseline. Follow-up questionnaire completed at least 1 time in 5 years.
Behavioral: 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.

Other Name: Surveys

Procedure: Blood Draw/Saliva Sample
About 2-3 tablespoons blood drawn. Participants may give a saliva sample instead.

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.
Behavioral: 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.

Other Name: Surveys

Procedure: Blood Draw/Saliva Sample
About 2-3 tablespoons blood drawn. Participants may give a saliva sample instead.

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.
Behavioral: 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.

Other Name: Surveys

Procedure: Blood Draw/Saliva Sample
About 2-3 tablespoons blood drawn. Participants may give a saliva sample instead.




Primary Outcome Measures :
  1. Variations in Clinical Features Compared Between Proband Group and Family Member Group [ Time Frame: 5 years ]
    Comparison made using 1-way ANOVA or Chi-squared tests.


Secondary Outcome Measures :
  1. Variations in the Overall Disease Phenotype Between Proband Group and Family Member Group [ Time Frame: 5 years ]
    Disease phenotype 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.


Biospecimen Retention:   Samples With DNA
Blood (about 2-3 tablespoons) drawn.


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants that have, or are suspected to have, a hereditary colorectal cancer syndrome registered at MD Anderson and family members.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863172


Contacts
Layout table for location contacts
Contact: Yi-Qian N. You, MD 713-792-6940 YNYou@mdanderson.org

Locations
Layout table for location information
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77330
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Yi-Qian N. You, MD M.D. Anderson Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02863172     History of Changes
Other Study ID Numbers: PA11-0567
2015-00051016-Y1 ( Other Grant/Funding Number: MD Anderson )
2016-00051406 ( Other Grant/Funding Number: Eduardo Vilar-Sanchez, MD, PhD, Germline Precision Prevention in Adolescents )
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Hereditary colorectal cancer syndrome
Questionnaires
Surveys
Blood sample
Saliva sample
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Syndrome
Disease
Pathologic Processes
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases