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Chronic and Late Effects of Non-Hodgkin's Lymphoma and Its Treatment in Long Term Survivors
This study has been completed.
First Received: November 3, 1999   Last Updated: March 3, 2008   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001301
  Purpose

Non-Hodgkin's lymphoma has been studied in the Pediatric Branch for at least 20 years, during which time a number of different treatment protocols have been used. Approximately 110 patients have apparently been cured of their lymphoma. The present protocol has no therapeutic component, but is designed to document the late effects that may have been encountered by our patients, either as a consequence of the disease or its treatment. In essence, patients who consent to participate will be asked a series of questions pertaining to the quality of their life and possible medical problems that they may be encountering. In addition, they will receive a complete physical examination and undergo non-invasive investigations designed to identify the presence of unsuspected late effects. Investigators in the Eye Clinic, Dental Clinic, Audiology, Cardiology and Endocrinology departments will participate in the protocol. As a part of the study, blood samples will be obtained to investigate the possibility that predisposing genetic factors may be identifiable in the patients normal cells (e.g., p53 mutations, evidence of DNA instability). If such abnormalities are detected, blood samples from family members will also be examined to determine whether the defect was inherited.


Condition
Lymphoma, Non-Hodgkin

Study Type: Observational
Official Title: Chronic and Late Effects of Non-Hodgkin's Lymphoma and Its Treatment in Long Term Survivors

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 107
Study Start Date: August 1992
Estimated Study Completion Date: April 2000
Detailed Description:

Non-Hodgkin's lymphoma has been studied in the Pediatric Branch for at least 20 years, during which time a number of different treatment protocols have been used. Approximately 110 patients have apparently been cured of their lymphoma. The present protocol has no therapeutic component, but is designed to document the late effects that may have been encountered by our patients, either as a consequence of the disease or its treatment. In essence, patients who consent to participate will be asked a series of questions pertaining to the quality of their life and possible medical problems that they may be encountering. In addition, they will receive a complete physical examination and undergo non-invasive investigations designed to identify the presence of unsuspected late effects. Investigators in the Eye Clinic, Dental Clinic, Audiology, Cardiology and Endocrinology departments will participate in the protocol. As a part of the study, blood samples will be obtained to investigate the possibility that predisposing genetic factors may be identifiable in the patients normal cells (e.g., p53 mutations, evidence of DNA instability). If such abnormalities are detected, blood samples from family members will also be examined to determine whether the defect was inherited.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Patients with a histologic diagnosis of small noncleaved cell (undifferentiated) (SNCL), lymphoblastic (LL), and large cell lymphoma (LCL) who were treated according to National Cancer Institute Pediatric Branch non-Hodgkin's lymphoma protocols 74-0, 75-6, 76-5, 77-04, 85-C-67, and 89-C-41A, and who have been in continuous remission for one year or longer following completion of treatment.

Patients who have relapsed and been successfully re-treated are not excluded, except for patients with lymphoblastic lymphoma who have been re-treated according to acute lymphoblastic leukemia protocols.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001301

Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
Study ID Numbers: 920242, 92-C-0242
Study First Received: November 3, 1999
Last Updated: March 3, 2008
ClinicalTrials.gov Identifier: NCT00001301     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Adverse Effects
Burkitt's Lymphoma
Diffuse Large Cell Lymphoma
Extended Remission
Health Status
Lymphoblastic Lymphoma
Molecular Studies

Additional relevant MeSH terms:
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on November 27, 2009