Molecular Epidemiology of Lymphoma Patients

February 23, 2012 updated by: M.D. Anderson Cancer Center

Primary Objectives:

  1. To enroll and obtain, through questionnaires, risk factor information on all study participants to develop detailed demographic, epidemiologic and behavioral profiles.
  2. To assess the influence of relevant epidemiologic covariates such as age, gender, smoking and family history of cancer on the panel of susceptibility biomarkers.
  3. To evaluate the role of genomic instability in development of lymphomas.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This study will include individuals diagnosed with lymphoma and individuals with no history of cancer. Half of the participants in this study will have lymphoma, and half will have no history of cancer. Information from both groups will be compared to help researchers try to learn which factors may lead to the development of lymphoma.

If you agree to take part in this study, you will be asked to complete a questionnaire at M. D. Anderson. In this questionnaire, you will be asked about your demographics (such as your age, sex, etc.), certain environmental exposures (such as pollution), your medical history, family history, diet, and your past and present smoking and alcohol use habits. This questionnaire should take about 50 minutes to complete.

You will also have about 2 ½ tablespoons of blood drawn for special tests. These tests will look for any biologic factors (such as changes in your DNA) that may be linked to lymphoma. You will not be informed of the results of any of the testing done with your blood samples.

Your participation will be over in this study once your blood has been drawn.

This is an investigational study. Up to 800 participants will take part in this study. All will be enrolled at M. D. Anderson.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants in this study will include 400 with newly diagnosed lymphoma and 400 matched controls.

Description

Inclusion Criteria:

  1. Cases only: Newly diagnosed, previously untreated patients with lymphoma as the primary cancer.
  2. Age 18 years and older.
  3. Willing to donate 30ml of blood.
  4. Willing to complete a self-administered questionnaire.
  5. Controls only: No prior cancer.

Exclusion Criteria:

  1. Cases only: Prior history of cancer other than lymphoma.
  2. Unable to speak or read English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
Participants of study with newly diagnosed lymphoma.
Behavioral: Questionnaire
Questions about cancer risk factors, medical history, and family history of cancer.
Other Names:
  • Survey
Control
Participants of study from matched control group.
Behavioral: Questionnaire
Questions about cancer risk factors, medical history, and family history of cancer.
Other Names:
  • Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To identify biologic (such as genes) and lifestyle factors that may increase a person's risk of developing lymphoma.
Time Frame: 4 Years
4 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Randa El-Zein, MD, PhD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

June 19, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (Estimate)

June 20, 2007

Study Record Updates

Last Update Posted (Estimate)

February 24, 2012

Last Update Submitted That Met QC Criteria

February 23, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-0281

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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