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Home > "C" Clinical Trials Conditions > Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer  Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer
Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer
For Condition: Lymphoma,Leukemia
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will try to discover how genetic and environmental factors contribute to the development of blood or lymph node cancer and related conditions. Individuals of any age with a personal and family history of a hematologic (blood or lymph node) cancer of an unusual type, pattern, or number may be eligible for this study. Of particular interest are chronic lymphocytic leukemia, Waldenstrom's macroglobulinemia, non-Hodgkin's lymphoma, Hodgkin disease, and mixed hematologic and lymphoproliferative, meaning different LPDs appearing within a family (i.e. a family with 2 sisters with CLL) and lymphoproliferative diseases. Participants will have the following procedures: - Fill out one or two questionnaires about their personal and family medical history - Provide written consent for researchers to review their medical records and pathology materials related to their care and those of deceased relatives with blood or lymph node cancer, tumors, or other related illnesses for whom they are the legally authorized representative - Donate a blood or cheek cell sample or a lock of hair to be used for genetic studies. In addition, patients may also be evaluated at the NIH Clinical Center for a complete medical history and physical examination, routine blood tests, urinalysis, and possibly some of the following tests: - X-rays, ultrasound and magnetic resonance imaging (MRI) studies to detect tumors or changes in tumors or other types of changes in specific tissues - MRI is a diagnostic test that uses strong magnetic fields and radiowaves to examine body tissues. The subject lies on a table that is moved into a large tunnel-like machine (the scanner) for about 45 minutes to 1 hour. - Cell surface marker test - White blood cells (or lymph nodes or bone marrow, if available) are tested to confirm the diagnosis of cancer and rule out other closely related conditions. The test is also done on family members to look for early changes that can indicate a risk of cancer in the family. - Skin biopsy - The area of skin to be biopsied is numbed with a local anesthetic and a 1/4-inch piece of skin is removed with a cookie cutter-like instrument. The wound is then covered with a band aid. - Bone marrow test - An area over the bony part of the lower back is numbed with a local anesthetic. A needle is then inserted and a few teaspoons of blood from the bone is withdrawn, along with a tiny sliver of bone. This provides information about the ability of the bone marrow to produce blood cells. - Leukapheresis - This is a procedure for collecting large quantities of white blood cells. Whole blood is withdrawn through a needle placed in an arm vein, similar to donating blood, and channeled into a machine that separates it into its components. The white cells are removed and the rest of the blood is returned to the donor through a needle in the other arm. - Fluorescein angiography - A yellow dye injected into an arm vein travels to the blood vessels in the eyes. Pictures of the retina-a thin layer of tissue that lines the back of the eye-are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. When the tests are finished, a doctor will discuss the results with the participant and the need, if any, for clinical follow-up.
Details: This is a clinical, epidemiologic, genetic and laboratory study of individuals and families at high risk of hematologic and lymphoproliferative cancer designed to investigate genetic susceptibility and environmental exposures which may alter cancer risk. Families with multiple members who have an unusual pattern or number of leukemia/lymphomas are evaluated clinically. The evaluation conducted is specific for the type of family being studied and is targeted toward defining affection status of each individual for genetic epidemiologic studies. Genetic and environmental risk factor information specific for the tumor type(s) is obtained. Individuals with, or at high risk of hematologic cancer because of their personal, familial, or environmental histories are identified by health care worker referral or by personal inquiry (i.e. self-referral). Relevant etiologic risk factor information is documented through review of pathology specimens and medical, vital, and genealogical records. Selected individuals and family members are asked to complete questionnaires and to undergo physical examinations specific for the tumor of interest (for definition of affection status) and to donate biologic specimens in a search for clues to cancer etiology and mechanisms of leukemogenesis/lymphogenesis. No anti-cancer therapy is administered. Therapeutic interventions are limited to counseling, education for cancer prevention, risk reduction, and early detection. Referral for evaluation by other ongoing NCI Treatment protocols will be made when appropriate. Genetic testing for specific mutations predictive of disease does not currently exist for any of the malignancies in this group. In the future, if such testing becomes available and other criteria are met (Clinical Laboratory Improvement Amendment approved test available, reasonable risk estimates can be derived, risk notification procedures developed) a separate protocol and consent procedure will be developed. Once enrolled, study participants are monitored prospectively for the development of outcomes of interest, typically by mail or telephone contact. In selected instances, subjects may return to the Clinical Center periodically for study-specific follow-up examinations. Although we do not offer specific anti-cancer therapy as part of this protocol we provide assistance so that study participants who require treatment for problems that develop during the course of the study are referred to appropriate health providers and we are available to provide advice and consultation related to the management of the familial cancer syndrome.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: On referral, persons of any age will be considered for inclusion in the study because of either: A family or personal medical history of hematologic/ lymphoproliferative malignancy of any unusual type, pattern, or number; or, Known or suspected factor(s) predisposing to hematologic malignancy, either genetic and/or congenital factors (birth defects, metabolic phenotype, chromosomal anomalies or Mendelian traits associated with tumors), environmental exposure (medications, occupation, radiation, diet, infectious agents, etc.), or unusual demographic features (very young age of onset multiple tumors, etc.). Personal and family medical history must be verified through questionnaires, interviews, and review of pathology slides and medical records. For familial neoplasms, two or more living affected cases among family members are generally required, although in selected instances exceptions may be made, e.g., for WM, one cases plus a living 1st degree relative with an autoimmune condition will qualify a family for further investigations. Familial aggregation of any hematologic cancer(s) is eligible for study, our current active accrual efforts fall into 5 categories 1. Chronic lymphocytic leukemia (CLL) 2. Waldenstrom's macroglobulinemia (WM) 3. Non-Hodgkin's Lymphoma (NHL) 4. Hodgkin disease (HD) 5. Mixed hematologic and lymphoproliferative diseases EXCLUSION CRITERIA: Referred individuals for whom reported diagnosis cannot be verified. Referred individuals who decline informed consent.
Total Enrollment: 3000
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 020210; 02-C-0210
Study Start Date: June 19, 2002
Record last reviewed: June 3, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039676
Other Leukemia Studies:
1. PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma
2. Chemotherapy Plus Radiation Therapy and Biological Therapy in Treating Patients With Hematologic Cancer
3. Physician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage Cancer
4. Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer or Aplastic Anemia
5. Beta Alethine in Treating Patients With Low-Grade Lymphoma
Related Studies:
Other Leukemia Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer
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