Epidemiology Controls Using Healthy Participants

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00476632
First received: May 21, 2007
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

The goal of this research study is to identify biologic and lifestyle factors that may increase a person's risk of developing certain types of cancer.

Objectives:

  1. Enroll healthy participants who can serve as controls for approved IRB case-control protocols ID00-098 and ID03-0250.
  2. Obtain detailed risk factor and food frequency questionnaires.
  3. Collect and store blood samples on all participants.

Condition Intervention
Healthy
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Epidemiology Controls Using Healthy Participants

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To identify biologic and lifestyle factors that may increase a person's risk of developing certain types of cancer. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

2 ½ tablespoons of blood drawn.


Estimated Enrollment: 1500
Study Start Date: June 2004
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Control
Person with no history of cancer.
Behavioral: Questionnaire
50 Minute Interview
Other Name: Survey

Detailed Description:

For this study, you will be asked to complete a personal interview. During the interview, you will be asked questions about your demographics (age, sex, etc.), certain environmental exposures, your medical history, family history, your diet, and your smoking and alcohol use histories. It should take around 50 minutes to complete the interview.

You will also have around 2 ½ tablespoons of blood drawn for special tests. These tests will look for any biologic factors associated with certain cancers. The interview and blood draw will be scheduled at the time and place of your convenience. You will not be informed of the results of any of the testing done with your samples.

There is a possibility that you might be contacted in the future about if researchers need clarification on any of information already collected. You are free to refuse any further participation if you wish.

This is an investigational study. Up to 1,500 participants will take part in this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Individuals 18 years or older with no history of cancer.

Criteria

Inclusion Criteria:

  1. Individuals ages 18 and over with no prior cancer
  2. Willing and able to complete an administered questionnaire
  3. Willing and able to donate 30 mL of blood

Exclusion Criteria:

  1. Individuals with prior cancer
  2. Individuals under the age of 18
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476632

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Sara Strom, PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00476632     History of Changes
Other Study ID Numbers: 2004-0112
Study First Received: May 21, 2007
Last Updated: October 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Epidemiology
Questionnaire
Controls

ClinicalTrials.gov processed this record on September 16, 2014