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Genetic Study of Chronic Lymphocytic Leukemia Families


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N/A
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Open (Enrolling)
Both
Leukemia

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Trial Information

Genetic Study of Chronic Lymphocytic Leukemia Families


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.


Inclusion Criteria:



1. Patients with histologically confirmed CLL who have living 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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Candidate susceptibility genes for familial chronic lymphocytic leukemia (CLL)

Outcome Time Frame:

Data collection over 6 years

Safety Issue:

No

Principal Investigator

Sara Strom, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID03-0117

NCT ID:

NCT00503256

Start Date:

September 2003

Completion Date:

Related Keywords:

  • Leukemia
  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Lymphoma
  • Questionnaire
  • Survey
  • CLL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030