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Home > "A" Clinical Trials Conditions > 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
A Pilot Study of Non-Hodgkin's Lymphoma: Chemotherapy and Blood Levels of Organochlorines
For Condition: HIV Infections,Lymphoma, AIDS-Related,Lymphoma, Non-Hodgkin
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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).
Details: 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:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 20
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 970075; 97-C-0075
Study Start Date: February 7, 1997
Record last reviewed: January 1, 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001571
Other Hiv Infections Studies:
1. A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of Low Dose MN rsgp120/HIV-1 (Genentech) in Combination with QS21 Adjuvant or Alum in Healthy Adults
2. Safety and Antifungal Activity of Recombinant Interferon-gamma 1b (rIFN-gamma 1b) Given with Standard Therapy in Patients with Cryptococcal Meningitis
3. The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients
4. A Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease
5. A Study of HIV-Disease Development in Aging
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A Pilot Study of Non-Hodgkin's Lymphoma: Chemotherapy and Blood Levels of Organochlorines
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