Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Pilot Study of Non-Hodgkin's Lymphoma: Chemotherapy and Blood Levels of Organochlorines
This study has been completed.
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001571
  Purpose

Non-Hodgkin's lymphoma (NHL) is the third most rapidly increasing cancer in the United States. HIV-related NHL is responsible for some of the increase since the early 1980s. However, it cannot explain the steady increase in the incidence rates in earlier years, nor the entire increase shown recently. A possible role of environmental exposures is receiving attention. One possibility is that exposure to organochlorines (OCs) may be related to the occurrence of NHL. NCI is currently designing a large population-based case-control study to investigate this hypothesis further by analyzing OC levels in blood collected at the time of interview from cases of NHL and their matched controls. At the time of these interviews, cases in the main case-control study would most likely have already received chemotherapy. If chemotherapy changes the blood levels of OCs, this may lead to misclassification of exposure among cases and eventually to biased risk estimates. The purpose of this pilot study is to estimate the bias due to measuring the serum levels of OCs in cases during or after chemotherapy. Twenty newly diagnosed patients will be recruited for the study. From each patient, four consecutive blood samples, one prior to, two during, and one after chemotherapy, will be collected. Forty pairs of pre-existing cryopreserved serum samples (pre- and post-treatment) taken from the NHL patients who participated in an earlier NCI clinical study will also be included in this study. Samples will be assayed for OC levels. The results will be used to plan and to interpret another large case-control study (the main study).


Condition
HIV Infections
Lymphoma, AIDS-Related
Lymphoma, Non-Hodgkin

MedlinePlus related topics: AIDS Cancer Lymphoma
U.S. FDA Resources
Study Type: Observational
Official Title: A Pilot Study of Non-Hodgkin's Lymphoma: Chemotherapy and Blood Levels of Organochlorines

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

Estimated Enrollment: 20
Study Start Date: February 1997
Estimated Study Completion Date: December 2000
Detailed Description:

Non-Hodgkin's lymphoma (NHL) is the third most rapidly increasing cancer in the United States. HIV-related NHL is responsible for some of the increase since the early 1980s. However, it cannot explain the steady increase in the incidence rates in earlier years, nor the entire increase shown recently. A possible role of environmental exposures is receiving attention. One possibility is that exposure to organochlorines (OCs) may be related to the occurrence of NHL. NCI is currently designing a large population-based case-control study to investigate this hypothesis further by analyzing OC levels in blood collected at the time of interview from cases of NHL and their matched controls. At the time of these interviews, cases in the main case-control study would most likely have already received chemotherapy. If chemotherapy changes the blood levels of OCs, this may lead to misclassification of exposure among cases and eventually to biased risk estimates. The purpose of this pilot study is to estimate the bias due to measuring the serum levels of OCs in cases during or after chemotherapy. Twenty newly diagnosed patients will be recruited for the study. From each patient, four consecutive blood samples, one prior to, two during, and one after chemotherapy, will be collected. Forty pairs of pre-existing cryopreserved serum samples (pre- and post-treatment) taken from the NHL patients who participated in an earlier NCI clinical study will also be included in this study. Samples will be assayed for OC levels. The results will be used to plan and to interpret another large case-control study (the main study).

  Eligibility

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

All NHL patients who have not previously received chemotherapy and who are admitted to the NCI Clinical Center to be enrolled in trails will be eligible for the study.

All histological subtypes and stages.

Any NHL patient who is between the ages of 20 and 74.

Must be able to give informed consent.

No NHL patient HIV positive will be included.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001571

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

Publications:
Study ID Numbers: 970075, 97-C-0075
Study First Received: November 3, 1999
Last Updated: March 3, 2008
ClinicalTrials.gov Identifier: NCT00001571  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cancer
DDT, PCB
Epidemiology
Pesticides
Serum

Study placed in the following topic categories:
Lymphoma, AIDS-related
Sexually Transmitted Diseases, Viral
Immunoproliferative Disorders
Acquired Immunodeficiency Syndrome
Lymphoma, small cleaved-cell, diffuse
Immunologic Deficiency Syndromes
Lymphoma, B-Cell
Virus Diseases
Lymphatic Diseases
Lymphoma, AIDS-Related
HIV Infections
B-cell lymphomas
Sexually Transmitted Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Retroviridae Infections

Additional relevant MeSH terms:
Neoplasms
RNA Virus Infections
Neoplasms by Histologic Type
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009