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Etiology of Multiple Myeloma: A Case-Control Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00505999
First received: July 24, 2007
Last updated: September 26, 2012
Last verified: September 2012
History of Changes
  Purpose

Primary Objectives:

  1. To enroll and obtain, through self-administered questionnaires, risk factor information on all study participants to develop detailed demographic, epidemiologic, and behavioral profiles. This study will accrue 250 Multiple Myeloma (MM) patients from MDACC and 250 healthy controls selected from friends and spouses who accompany patients to the MDACC clinics. Blood (25 ml) and buccal samples will be collected from all participants.
  2. To identify risk factors associated with MM by integrating epidemiological, clinical and molecular information using a case-control approach.
  3. To evaluate constitutional markers of genetic susceptibility as predictors of MM risk. Gene-environment interactions will be explored.

Condition Intervention
Multiple Myeloma
 Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Etiology of Multiple Myeloma: A Case-Control Study

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • The goal of this epidemiological research study is to identify biological and lifestyle factors that may be associated with the development of Multiple Myeloma (MM). [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood and saliva samples that will be used for special tests to look for any biological factors associated with Multiple Myemloma (MM).


Estimated Enrollment: 500
Study Start Date: July 2006
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Questionnaire
Patients diagnosed with Multiple Myeloma and healthy controls.
 Behavioral: Questionnaire
Questionnaire taking 30-40 minutes to complete.
Other Name: Survey

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with Multiple Myeloma and healthy controls.

Criteria

Inclusion Criteria:

  1. Cases: MDACC patients with confirmed MM who consent to complete a risk factor questionnaire and donate a 25ml blood specimen and a buccal sample.
  2. Controls: Friends or spouses of MDACC patients matched on age (±5 years), sex and ethnicity who consent to complete a risk factor questionnaire and donate a 25 ml blood specimen and a buccal sample.

Exclusion Criteria:

  1. Cases: No exclusion criteria.
  2. Controls: Previous history of invasive cancer (excluding non-melanoma skin cancer)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00505999

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Sara Strom, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
The University of Texas M.D.Anderson Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00505999     History of Changes
Other Study ID Numbers: 2006-0141
Study First Received: July 24, 2007
Last Updated: September 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Multiple Myeloma
Etiology
Risk Factors
 Healthy Controls
Questionnaire
Survey

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013