Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00505999
Status:
UNKNOWN
Last Update Posted:
2020-01-02
First Post:
2007-07-24
Brief Title:
Etiology of Multiple Myeloma A Case-Control Study
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Etiology of Multiple Myeloma A Case-Control Study
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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 doctors 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 andor 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 doctors 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
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 andor 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 doctors 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 andor 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 doctors 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R25CA057730 | NIH | None | httpsreporternihgovquickSearchR25CA057730 |