Etiology of Multiple Myeloma: A Case-Control Study

NCT00505999 | Unknown

• 2 other identifiers: 2006-0141R25CA057730
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: The overall objective of this project is to identify risk factors associated with the development of multiple myeloma (MM) by integrating epidemiologic, clinical and molecular information. We plan to invite MDACC patients with MM, as well as controls, to participate in this investigative case-control study. Controls will be selected from friends and spouses who accompany patients to the various MDACC clinics and will be matched to the cases on age (±5 years), gender, and ethnicity. We will obtain demographic, risk factor and clinical information along with a blood and buccal sample from all cases and controls. This study could have implications for prevention and subsequent reduction in the incidence of multiple myeloma. Collecting blood and buccal samples will allow us to study the role genetic susceptibility plays in MM risk. The specific aims are:

1. 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 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. 2.To identify risk factors associated with MM by integrating epidemiological, clinical and molecular information using a case-control approach.
3. 3.To evaluate constitutional markers of genetic susceptibility as predictors of MM risk. Gene-environment interactions will be explored.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Etiology; Risk Factors; Healthy Controls; Questionnaire; Survey

Outcome Measures

Primary Outcomes (1)

• 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).

  2 Years

Study Arms (1)

Questionnaire

Patients diagnosed with Multiple Myeloma and healthy controls.

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Questionnaire taking 30-40 minutes to complete.

Also known as: Survey

Questionnaire

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Multiple Myeloma and healthy controls.

You may qualify if:

• Cases: MDACC patients with confirmed MM who consent to complete a risk factor questionnaire and donate a 25ml blood specimen and a buccal sample.
• 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.

You may not qualify if:

• Controls: Previous history of invasive cancer (excluding non-melanoma skin cancer)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

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 Myeloma (MM).

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Michelle Hildebrandt, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2007
• First Posted: July 25, 2007
• Study Start: July 1, 2006
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: January 2, 2020

Record last verified: 2019-12

Locations

US (1)