- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001571
A Pilot Study of Non-Hodgkin's Lymphoma: Chemotherapy and Blood Levels of Organochlorines
March 3, 2008 updated by: National Cancer Institute (NCI)
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).
Study Overview
Status
Completed
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).
Study Type
Observational
Enrollment
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cantor KP, Blair A, Everett G, Gibson R, Burmeister LF, Brown LM, Schuman L, Dick FR. Pesticides and other agricultural risk factors for non-Hodgkin's lymphoma among men in Iowa and Minnesota. Cancer Res. 1992 May 1;52(9):2447-55.
- Gammon MD, Wolff MS, Neugut AI, Terry MB, Britton JA, Greenebaum E, Hibshoosh H, Levin B, Wang Q, Santella RM. Treatment for breast cancer and blood levels of chlorinated hydrocarbons. Cancer Epidemiol Biomarkers Prev. 1996 Jun;5(6):467-71.
- Hoffman W. Organochlorine compounds: Risk of non-Hodgkin's lymphoma and breast cancer? Arch Environ Health. 1996 May-Jun;51(3):189-92. doi: 10.1080/00039896.1996.9936015.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 1997
Primary Completion
December 6, 2022
Study Completion
December 1, 2000
Study Registration Dates
First Submitted
November 3, 1999
First Submitted That Met QC Criteria
December 9, 2002
First Posted (Estimate)
December 10, 2002
Study Record Updates
Last Update Posted (Estimate)
March 4, 2008
Last Update Submitted That Met QC Criteria
March 3, 2008
Last Verified
January 1, 2000
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 970075
- 97-C-0075
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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