Clinical trial NCT00505999: Etiology of Multiple Myeloma: A Case-Control Study
Official title: Etiology of Multiple Myeloma: A Case-Control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Etiology
Risk Factors
Healthy Controls
Questionnaire
Survey
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-07-25
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Multiple Myeloma and healthy controls.

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. 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. 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.

Detailed description: Informed Consent For Control Subjects:

In this study, researchers are trying to learn about factors that may be associated with MM.

For this study, you will be asked to complete a questionnaire. The questionnaire asks questions about your demographics (for example, age and sex), any chemicals you may have been exposed to, your medical history, family history of cancer, your diet, and your history of smoking and/or alcohol use. It should take around 30-40 minutes to complete the questionnaire.

Blood (about 2-3 tablespoons) will be drawn. You will spit into a collection container in order to provide a sample of your saliva. The blood and saliva samples will be used for special tests to look for any biological factors associated with MM.

If you live in Houston or the surrounding area, study personnel can arrange to collect the samples at the time and place of your convenience. If you do not live in the Houston area, sample collection instructions and supplies will be mailed to you. The blood sample may be drawn at your doctor's office, or at a clinic or hospital of your choice. All mailing costs will be paid by the study. No travel to M. D. Anderson will be required.

You will be considered off-study after the data that is collected has been processed.

This is an investigational study. Up to 500 participants will take part in this study. All will be enrolled at M. D. Anderson.

Informed Consent for Patients:

In this study, researchers are trying to learn about factors that may be associated with MM.

For this study, you will be asked to complete a questionnaire. The questionnaire asks questions about your demographics (for example, age and sex), any chemicals you may have been exposed to, your medical history, family history of cancer, your diet, and your history of smoking and/or alcohol use. It should take around 30-40 minutes to complete the questionnaire.

Blood (about 2-3 tablespoons) will be drawn. You will spit into a collection container in order to provide a sample of your saliva. The blood and saliva samples will be used for special tests to look for any biological factors associated with MM.

If you live in Houston or the surrounding area, study personnel can arrange to collect the samples at the time and place of your convenience. If you do not live in the Houston area, sample collection instructions and supplies will be mailed to you. The blood sample may be drawn at your doctor's office, or at a clinic or hospital of your choice. All mailing costs will be paid by the study. No travel to M. D. Anderson will be required.

Neither you nor your doctor will receive the results of these tests, and they will not be put in your medical record.

You will be considered off study after the data that is collected has been processed.

This is an investigational study. Up to 500 participants will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility 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)

Primary outcomes:
measure: 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).
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Michelle Hildebrandt, PhD
role: PRINCIPAL_INVESTIGATOR
References: