Brain CancerNCT00505141
Urban Environmental Exposures and Childhood Cancer
An observational study of Brain Cancer and Acute Lymphoblastic Leukemia, run by Georgetown University at 1 site in United States.
Trial summary
The Environmental Protection Agency has recognized that organophosphorus pesticides require close regulation and continued monitoring for human health effects and some (e.g chlorpyrifos) have been phased-out from the consumer market due to the special risk that it posed for children. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Cancer, Acute Lymphoblastic Leukemia
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Feb 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Only newly diagnosed cases of ALL and brain cancers (i.e. diagnosed within the previous 12 months) under the age of 18 years are eligible for this study. These will include live born infants at term or born prematurely, and any cases we are able to ascertain from pediatric hematology records.
- Healthy controls of similar age will be recruited.
- The children must have a parent available to be interviewed who speaks English or Spanish well enough to understand the questionnaire.
Who cannot join
- Subjects with a diagnosis of Down syndrome or other chromosomal disorder, single gene disorder, or recognized multi-organ syndrome will be excluded.
- Non-residents of Maryland, the District of Columbia, and Virginia will be excluded; this will avoid the inclusion of out-of-state case families who traveled a long distance for clinical care, where control sampling would be problematic.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Case-Control Study of Urban Environmental Effects on Childhood Leukemia and Brain Cancer
The Environmental Protection Agency has recognized that organophosphorus pesticides require close regulation and continued monitoring for human health effects and some (e.g chlorpyrifos) have been phased-out from the consumer market due to the special risk that it posed for children. There is growing evidence in support of the association between pesticide exposure and childhood leukemia. Studies of pesticides and their association with childhood cancer have been limited by study designs, self-reporting and lack of biological measurements. While several large studies in California found little evidence of an association between agricultural pesticide use and childhood leukemia, these results are in contrast with the associations observed with household exposures to pesticides. The real association may depend on timing of exposure, type of pesticide, dose and pathway of exposure. Furthermore, some persons may be more susceptible to the effects of specific pesticides due to inherited mutations in their detoxification pathways.
We are conducting a pilot study to test the hypothesis that environmental exposure to pesticides in pregnancy or during the neonatal period, together with genetic susceptibility may lead to childhood ALL or brain cancer. The study is a multicenter, case-control study, based on collaboration between clinical researchers and basic science research to evaluate the risk for childhood cancer in relation to measured levels of pesticides (and their metabolites) and genetic polymorphisms. Biomarkers will be used to examine the risks of chronic low-dose exposures, and to characterize relationships between specific pesticides, childhood cancer and genetic susceptibility.
Hypothesis: Interaction between environmental factors (pesticides) and maternal or child genetic polymorphisms may lead to childhood cancer.
- Conditions
- Brain Cancer, Acute Lymphoblastic Leukemia
- Keywords
- Childhood Brain Cancer, Childhood Acute Lymphoblastic Leukemia
- Medical subject headings
- Brain Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startSep 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Investigators
- Offie P Soldin, Principal investigator, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505141
- Sponsor's protocol ID
- 2004-278
- Status last verified
- Jul 2007
- First submitted
- 20 Jul 2007
- Last updated
- 23 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-Control Study of Urban Environmental Effects on Childhood Leukemia and Brain Cancer
- ClinicalTrials.gov ID
- NCT00505141
- Acronym / sponsor ID
- 2004-278
- Conditions
- Brain Cancer, Acute Lymphoblastic Leukemia
- Keywords
- Childhood Brain Cancer, Childhood Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Feb 2006 (actual)
- First posted
- 23 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Environmental Protection Agency has recognized that organophosphorus pesticides require close regulation and continued monitoring for human health effects and some (e.g chlorpyrifos) have been phased-out from the consumer market due to the special risk that it posed for children. There is growing evidence in support of the association between pesticide exposure and childhood leukemia. Studies of pesticides and their association with childhood cancer have been limited by study designs, self-reporting and lack of biological measurements. While several large studies in California found little evidence of an association between agricultural pesticide use and childhood leukemia, these results are in contrast with the associations observed with household exposures to pesticides. The real association may depend on timing of exposure, type of pesticide, dose and pathway of exposure. Furthermore, some persons may be more susceptible to the effects of specific pesticides due to inherited mutations in their detoxification pathways.
We are conducting a pilot study to test the hypothesis that environmental exposure to pesticides in pregnancy or during the neonatal period, together with genetic susceptibility may lead to childhood ALL or brain cancer. The study is a multicenter, case-control study, based on collaboration between clinical researchers and basic science research to evaluate the risk for childhood cancer in relation to measured levels of pesticides (and their metabolites) and genetic polymorphisms. Biomarkers will be used to examine the risks of chronic low-dose exposures, and to characterize relationships between specific pesticides, childhood cancer and genetic susceptibility.
Hypothesis: Interaction between environmental factors (pesticides) and maternal or child genetic polymorphisms may lead to childhood cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Only newly diagnosed cases of ALL and brain cancers (i.e. diagnosed within the previous 12 months) under the age of 18 years are eligible for this study. These will include live born infants at term or born prematurely, and any cases we are able to ascertain from pediatric hematology records.
- Healthy controls of similar age will be recruited.
- The children must have a parent available to be interviewed who speaks English or Spanish well enough to understand the questionnaire.
Key exclusion criteria (2 listed)
- Subjects with a diagnosis of Down syndrome or other chromosomal disorder, single gene disorder, or recognized multi-organ syndrome will be excluded.
- Non-residents of Maryland, the District of Columbia, and Virginia will be excluded; this will avoid the inclusion of out-of-state case families who traveled a long distance for clinical care, where control sampling would be problematic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Offie P Soldin principal investigator
Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Cancer and Acute Lymphoblastic Leukemia, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2007.