Etiology of Multiple Myeloma: A Case-Control Study
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
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:
- 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.
- To identify risk factors associated with MM by integrating epidemiological, clinical and molecular information using a case-control approach.
- To evaluate constitutional markers of genetic susceptibility as predictors of MM risk. Gene-environment interactions will be explored.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Cases: No exclusion criteria.
- •Controls: Previous history of invasive cancer (excluding non-melanoma skin cancer)
结局指标
主要结局
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).
时间窗: 2 Years
次要结局
未报告次要终点