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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00503256 |
Purpose
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'), researchers have identified CLL patients who have one or more living relative(s) affected with CLL or other leukemias or lymphomas. Researchers plan to invite probands (MDACC 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. Researchers will obtain demographic and clinical information along with specimens (blood and 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.
| Condition | Intervention |
|---|---|
|
Leukemia |
Behavioral: Questionnaire |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | Genetic Study of Chronic Lymphocytic Leukemia Families |
Blood and cheek cell sample collection that will be used for special tests to look for genes that may play a role in the development of CLL.
| Estimated Enrollment: | 2000 |
| Study Start Date: | September 2003 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Chronic lymphocytic leukemia (CLL) Patients and Relatives.
|
Behavioral: Questionnaire
Questionnaires each taking 60 minutes to complete.
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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.
You will also be asked to provide a sample of cheek cells by swishing mouthwash and spiting it 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. 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. All information will be kept confidential and used only for this research. 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 350 participants will be enrolled by M. D. Anderson researchers. A total of 2000 participants will be enrolled in this multicenter study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patients diagnosed with chronic lymphocytic leukemia (CLL) and their living unaffected or affected relatives.
Inclusion Criteria:
Relatives of the MDACC CLL patients who have CLL or other lymphoproliferative disorders (i.e., leukemia
Exclusion Criteria:
1. Inability to consent.
Contacts and Locations| Contact: Sara Strom, PhD | 713-792-3020 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Sara Strom, PhD | |
| Principal Investigator: | Sara Strom, PhD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Sara Strom, PhD/Associate Professor ) |
| Study ID Numbers: | ID03-0117 |
| Study First Received: | July 16, 2007 |
| Last Updated: | April 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00503256 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Chronic Lymphocytic Leukemia Leukemia Lymphoma |
Questionnaire Survey CLL |
|
Lymphatic Diseases Leukemia Chronic Lymphocytic Leukemia Leukemia, Lymphoid Immunoproliferative Disorders |
Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic Lymphoproliferative Disorders Leukemia, B-Cell Lymphoma |
|
Lymphatic Diseases Leukemia Neoplasms Leukemia, Lymphoid Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Leukemia, Lymphocytic, Chronic, B-Cell Lymphoproliferative Disorders Leukemia, B-Cell |
