Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Molecular Epidemiology of Lymphoma Patients

This study has been withdrawn prior to enrollment.
(No participants recruited, study discontinued.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00488553
First received: June 19, 2007
Last updated: February 23, 2012
Last verified: February 2012
  Purpose

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.

Condition Intervention
Lymphoma
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Molecular Epidemiology of Lymphoma Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To identify biologic (such as genes) and lifestyle factors that may increase a person's risk of developing lymphoma. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Subjects will also provide 30 cc of blood. The blood will be genotyped, and the genotype and epidemiological data will be used to evaluate the role of genomic instability (baseline and induced) in the development of lymphomas.


Enrollment: 0
Study Start Date: August 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cases
Participants of study with newly diagnosed lymphoma.
Behavioral: Questionnaire
Questions about cancer risk factors, medical history, and family history of cancer.
Other Name: Survey
Control
Participants of study from matched control group.
Behavioral: Questionnaire
Questions about cancer risk factors, medical history, and family history of cancer.
Other Name: Survey

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.

  Eligibility

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

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

Criteria

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
  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: NCT00488553

Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Randa El-Zein, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00488553     History of Changes
Other Study ID Numbers: 2006-0281
Study First Received: June 19, 2007
Last Updated: February 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Lymphoma
Epidemiology
Lifestyle Factors
Questionnaire
Survey

Additional relevant MeSH terms:
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 19, 2014