Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 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 | |
| NCI-2020-07461 | Other Identifier | Clinical Trials Reporting Program (CTRP) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Objectives:
Participants:
Questionnaires:
If participant agrees to take part in this study, participant will fill out a some questionnaires about participant's work, family history, medical history, and health habits. If participant has already answered these questionnaires when participant was registered as a patient at MD Anderson, the study staff will give participant a copy and review participant's answers with participant for any updates or if participant has any questions. It should take about 20 minutes to complete the questionnaires.
Participant will also complete a health and lifestyle questionnaire, which contains 20 questions for men and 22 questions for women. This questionnaire should take about 10 minutes to complete.
Participant may be given the questionnaires electronically on REDcap (a secure, web-based application used to collect data for research studies that participant can access from participant's phone, tablet, or computer), over the phone (either with a member of the study staff asking questions or by using an electronic response system called IVR), at home through the mail, or in person by a member of the research staff at participant's MD Anderson visit. If mailed, a postage-paid return envelope will be provided for the return of the questionnaire.
Blood or Saliva Sample:
Blood (about 2-3 tablespoons) will be drawn. If possible, the blood will be drawn during an already scheduled blood draw to avoid additional needle sticks.
If participant is unwilling or unable to give a blood sample, participant may give a saliva sample instead. If participant is at MD Anderson, a saliva kit will be given to participant. If participant is not at MD Anderson, the kit will be mailed to participant with instructions for collecting the saliva sample and a prepaid envelope will be included to return the sample to the study staff.
The blood or saliva sample will be sent to the research laboratory of the study chairs at MD Anderson for testing.
Residual Tissue Collection:
If participant has tissue from procedures performed at MD Anderson, this tissue may be requested from participant's previous procedures for testing. If participant has had procedures done at another institution, participant may be asked to sign a waiver to allow the tissue from the outside institution to be sent to MD Anderson for testing.
Follow-Up Questionnaires:
Participant will also fill out a follow-up questionnaire at least 1 time in 5 years to update participant's medical, cancer, and family history. Each questionnaire will take approximately 20 minutes to complete.
Withdrawing from the Study:
Participant may withdraw from participation in this study at any time. If participant decides participant wants to stop taking part in this study, data collected about participant and data taken from the blood or saliva samples participant has provided up to the time participant withdraws will remain in study database and will be used for the purposes of the study.
Length of Study:
Participant's active participation on this study will be over after the blood, tissue, and/or saliva samples have been collected and participant has completed all of the questionnaires.
This is an investigational study.
Up to 2,000 patients and/or family members will take part in this study. All will be enrolled at MD Anderson.
Family Members:
Questionnaire:
Participant will complete a health questionnaire, which will collect information about participant's personal medical history, demographics (age, race, sex, and so on), and questions about participant's alcohol and tobacco use. This questionnaire should take about 20 minutes to complete.
Participant may be given the questionnaires electronically on REDcap (a secure, web-based application used to collect data for research studies that participant can access from participant's phone, tablet, or computer), over the phone (either with a member of the study staff asking questions or by using an electronic response system called IVR), at home through the mail, or in person by a member of the research staff at participant's family member's MD Anderson visit.
If mailed, a postage-paid return envelope will be provided for the return of the questionnaire.
Blood or Saliva Sample:
If participant agrees to take part in this study and participant is able to come to MD Anderson, blood (about 2-3 tablespoons) will be drawn.
If participant is unwilling or unable to give a blood sample, participant may give a saliva sample instead. If participant is at MD Anderson, a saliva kit will be given to participant. If participant is not at MD Anderson, the kit will be mailed to participant with instructions for collecting the saliva sample and a prepaid envelope will be included to return the sample to the study staff.
The blood or saliva sample will be sent to the research laboratory of the study chairs at MD Anderson for testing.
Outside Tissue Collection:
If participant has had a procedure done at a hospital, surgical center, or doctor's office outside of MD Anderson, participant may optionally be asked to sign a waiver to allow tissue stored at the outside hospital, surgical center, or doctor's office to be sent to researchers at MD Anderson.
Follow-Up Questionnaires:
Participant will also fill out a follow-up questionnaire at least 1 time in 5 years to update participant's medical, cancer, and family history. Each questionnaire will take approximately 20 minutes to complete.
Withdrawing from the Study:
Participant may withdraw from participation in this study at any time. If participant decides participant wants to stop taking part in this study, data collected about participant and data taken from the blood or saliva samples participant has provided up to the time participant withdraws will remain in study database and will be used for the purposes of the study.
Length of Study Participant's active participation on this study will be over after the blood, outside tissue and/or saliva samples have been collected and participant has completed all of the questionnaires.
This is an investigational study. Up to 2,000 patients and/or family members will take part in this study. All will be enrolled at MD Anderson.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Variations in Clinical Features Compared Between Proband Group and Family Member Group | Comparison made using 1-way ANOVA or Chi-squared tests. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Variations in the Overall Disease Phenotype Between Proband Group and Family Member Group | 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. | 5 years |
Not provided
Inclusion Criteria:
Probands who meet the following criteria will be eligible:
Family members who meet the following criteria will be eligible:
Exclusion Criteria:
N/A
Not provided
Not provided
Not provided
Participants that have, or are suspected to have, a hereditary colorectal cancer syndrome registered at MD Anderson and family members.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi-Qian N. You, MD | Contact | 713-792-6940 | YNYou@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Yi-Qian N. You, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77330 | United States |
Not provided
| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood (about 2-3 tablespoons) drawn.
|
|
| Blood Draw/Saliva Sample | Procedure | About 2-3 tablespoons blood drawn. Participants may give a saliva sample instead. |
|
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |