Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503256
Status:
UNKNOWN
Last Update Posted:
2019-05-09
First Post:
2007-07-16
Brief Title:
Genetic Study of Chronic Lymphocytic Leukemia Families
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Genetic Study of Chronic Lymphocytic Leukemia Families
Status:
UNKNOWN
Status Verified Date:
2019-05
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:
The goal of this research is to identify genes that may be related to the risk of developing CLL
Objectives
The objective of this study to investigate possible candidate susceptibility genes for familial chronic lymphocytic leukemia CLL by identifying and recruiting high-risk families Through our ongoing study of familial aggregation in CLL kindreds protocol 2003-0498 Genetic Study of Chronic Lymphocytic Leukemia we have identified CLL patients who have one or more living or dead relatives affected with CLL or other leukemias or lymphomas We will also identify patients in high-risk families from referrals from leukemia clinicians and from self-referrals from patients who learn about our study from the ClinicalTrialsgov website We plan to invite probands patients diagnosed with CLL and their family members with other leukemias and lymphomas and a sample of unaffected relatives to participate in a geneticlinkage study We will obtain demographic and clinical information along with specimens blood or buccal samples from all participants These families will be part of the Genetic Epidemiology of CLL Consortium a multicenter multidisciplinary consortium based at the Mayo Clinic Cancer Center under the direction of Susan Slager PhD This is funded from NCI through a subcontract with Mayo Clinic
Genotypic data will be analyzed at Mayo Clinic and coded de-identified data will be shared with the NIH Genome-Wide Association Studies GWAS data repository
Objectives
The objective of this study to investigate possible candidate susceptibility genes for familial chronic lymphocytic leukemia CLL by identifying and recruiting high-risk families Through our ongoing study of familial aggregation in CLL kindreds protocol 2003-0498 Genetic Study of Chronic Lymphocytic Leukemia we have identified CLL patients who have one or more living or dead relatives affected with CLL or other leukemias or lymphomas We will also identify patients in high-risk families from referrals from leukemia clinicians and from self-referrals from patients who learn about our study from the ClinicalTrialsgov website We plan to invite probands patients diagnosed with CLL and their family members with other leukemias and lymphomas and a sample of unaffected relatives to participate in a geneticlinkage study We will obtain demographic and clinical information along with specimens blood or buccal samples from all participants These families will be part of the Genetic Epidemiology of CLL Consortium a multicenter multidisciplinary consortium based at the Mayo Clinic Cancer Center under the direction of Susan Slager PhD This is funded from NCI through a subcontract with Mayo Clinic
Genotypic data will be analyzed at Mayo Clinic and coded de-identified data will be shared with the NIH Genome-Wide Association Studies GWAS data repository
Detailed Description:
This study does not involve taking any medications
You will be asked to provide study personnel with authorization to request medical records from your physician the hospital andor from other health care facilities where you were diagnosed with cancer The information gathered will be used to help verify the diagnosis Study personnel may also need to contact you in the future by phone mail or e-mail in order to ask questions about the status of your health
For this research study you will be asked to have around 4 tablespoons of blood drawn from a vein in your arm or you will also be asked to provide a sample of cheek cells by spitting into a collection container The blood and cheek cell samples will be used for special tests to look for genes that may play a role in the development of CLL You will also be asked to complete a family history questionnaire and a risk factor questionnaire The family history questionnaire and the risk factor questionnaire will each take 60 minutes to complete You will need to contact your family members before you send the completed family history questionnaire back to the study staff You must ask for their permission to send the study staff their contact information Family members with CLL or other leukemias or lymphomas as well as a sample of your unaffected family members will then be contacted by study personnel about participating in the study
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
All blood and cheek cells collected will only be used by researchers involved in this study Genetic information from the analysis of your blood and cheek cells will be included in a repository of genetic information at the National Institutes of Health but no personal identifying information will be sent All information will be kept confidential Neither you nor your doctor will receive the results of these tests and they will NOT be put in your medical record
This is an investigational study Up to 450 participants will be enrolled by M D Anderson researchers A total of 4000 participants will be enrolled in this multicenter study
You will be asked to provide study personnel with authorization to request medical records from your physician the hospital andor from other health care facilities where you were diagnosed with cancer The information gathered will be used to help verify the diagnosis Study personnel may also need to contact you in the future by phone mail or e-mail in order to ask questions about the status of your health
For this research study you will be asked to have around 4 tablespoons of blood drawn from a vein in your arm or you will also be asked to provide a sample of cheek cells by spitting into a collection container The blood and cheek cell samples will be used for special tests to look for genes that may play a role in the development of CLL You will also be asked to complete a family history questionnaire and a risk factor questionnaire The family history questionnaire and the risk factor questionnaire will each take 60 minutes to complete You will need to contact your family members before you send the completed family history questionnaire back to the study staff You must ask for their permission to send the study staff their contact information Family members with CLL or other leukemias or lymphomas as well as a sample of your unaffected family members will then be contacted by study personnel about participating in the study
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
All blood and cheek cells collected will only be used by researchers involved in this study Genetic information from the analysis of your blood and cheek cells will be included in a repository of genetic information at the National Institutes of Health but no personal identifying information will be sent All information will be kept confidential Neither you nor your doctor will receive the results of these tests and they will NOT be put in your medical record
This is an investigational study Up to 450 participants will be enrolled by M D Anderson researchers A total of 4000 participants will be enrolled in this multicenter study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None