A Pilot Study of Non-Hodgkin's Lymphoma: Chemotherapy and Blood Levels of Organochlorines

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001571
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: January 2000

November 3, 1999
March 3, 2008
February 1997
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Complete list of historical versions of study NCT00001571 on ClinicalTrials.gov Archive Site
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A Pilot Study of Non-Hodgkin's Lymphoma: Chemotherapy and Blood Levels of Organochlorines
A Pilot Study of Non-Hodgkin's Lymphoma: Chemotherapy and Blood Levels of Organochlorines

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).

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).

Observational
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  • HIV Infections
  • Lymphoma, AIDS-Related
  • Lymphoma, Non-Hodgkin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2000
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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.

Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001571
970075, 97-C-0075
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National Cancer Institute (NCI)
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National Institutes of Health Clinical Center (CC)
January 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP