Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02863172 |
| Other study ID # |
PA11-0567 |
| Secondary ID |
2015-00051016-Y1 |
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 22, 2012 |
| Est. completion date |
May 30, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
Yi-Qian N. You, MD |
| Phone |
713-792-6940 |
| Email |
YNYou[@]mdanderson.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
Description:
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.
