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CompletedNCT00001571Updated Mar 4, 2008

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

An observational study in HIV Infections, Lymphoma, AIDS-Related and Lymphoma, Non-Hodgkin, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2008-03-04.

Sponsored by National Cancer Institute (NCI) · Observational

Study type
Observational
Enrollment
20
Sex
All
01

Study summary

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).

Read the 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).

02

Conditions studied

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

Keywords

  • Cancer
  • DDT, PCB
  • Epidemiology
  • Pesticides
  • Serum
03

In context

HIV Infections

4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 20 is below the median of 200 across 731 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,554 studies on the registry; 334 are open to participants now.

Of its 407 completed or terminated interventional studies of FDA-regulated products, 370 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.

05

Study design

Enrollment
20 participants
06

Study locations

1 site
  • National Cancer Institute (NCI)
    Bethesda, Maryland 20892, United States
07

References and documents

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. PubMed 1568215 ↗
  • 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. PubMed 8781744 ↗
  • 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. PubMed 8687239 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 1997 and a completion of Dec 2000. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 1999
First posted
Dec 10, 2002
Start
Feb 1997
Completion
Dec 2000
Last update
Mar 4, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Mar 4, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00001571
First posted
Dec 10, 2002
Start date
Feb 1997
Completion
Dec 2000
Last update
Mar 4, 2008
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2000. You cannot join it, but the record below documents what was studied.

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