Genetic Study of Chronic Lymphocytic Leukemia Families
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Blood Cancer, Leukemia |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 12/15/2018 |
| Start Date: | September 2003 |
| End Date: | September 2019 |
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 relative(s) 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 ClinicalTrials.gov
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
genetic/linkage 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.
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 relative(s) 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 ClinicalTrials.gov
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
genetic/linkage 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.
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, and/or 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 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.
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, and/or 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 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.
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.
Inclusion Criteria:
1. Patients with histologically confirmed CLL who have living or dead relatives affected
with CLL. They must agree to complete a risk factor questionnaire and a family history
questionnaire, and to donate a 50mL blood specimen or a buccal specimen.
2. Relatives of the CLL patients who have CLL or other lymphoproliferative disorders
(i.e., leukemia & lymphoma). They must agree to complete a risk factor questionnaire
and donate a 50mL blood specimen or a buccal specimen. They will need to sign an
authorization to release their medical records so that we can confirm their diagnosis.
3. A sample of unaffected relatives of the CLL patients. They must agree to complete a
risk factor questionnaire and donate a 50mL blood specimen or a buccal specimen.
Exclusion Criteria:
1) No exclusion criteria
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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