Soft Tissue SarcomaNCT00611078
Environmental Pollutants and the Risk of Soft Tissue Sarcoma: A Pilot Study
An observational study of Soft Tissue Sarcoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to assess the feasibility of conducting a large hospital based case control study of the role of dioxins and dioxinlike polychlorinated dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs). Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Sarcoma
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jan 2011
- 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 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Soft Tissue Sarcoma at Memorial Sloan Kettering Cancer Center.
Who may be able to join
- Patients with Soft tissue sarcoma at MSKCC are eligible for this study if they meet the following criteria:
- Between 18 and 79 years of age
- were diagnosed within the previous 6 months with primary soft tissue sarcoma of one of the following histologic subtypes: liposarcoma, leiomyoscaroma, MFH, or synovial sarcoma
- are enrolled in protocol 02-060 ("Novel Biochemical and Molecularr Determinants for Soft Tissue Sarcoma"; PI, Dr. Samuel Singer)
- controls will be eligibile for this study if they meet the following criteria
- are b/w 18-79 years of age
- have no prior history of cancer (other than non melanoma skin cancer)
Who cannot join
- Individuals will be excluded if they
- are unable to sign informed consent for medical or other reasons
- do not speak english
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
The purpose of this study is to assess the feasibility of conducting a large hospital based case control study of the role of dioxins and dioxinlike polychlorinated dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs).
- Conditions
- Soft Tissue Sarcoma
- Keywords
- Soft Tissue Sarcoma, environment, pollutants, 04-088
- Medical subject headings
- Sarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
enrollment of 60 participants
Measured: Conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startSep 2004
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Lawrence Engel, Ph.D., Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611078
- Sponsor's protocol ID
- 04-088
- Status last verified
- Jan 2011
- First submitted
- 25 Jan 2008
- Last updated
- 20 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Pollutants and the Risk of Soft Tissue Sarcoma: A Pilot Study
- ClinicalTrials.gov ID
- NCT00611078
- Acronym / sponsor ID
- 04-088
- Conditions
- Soft Tissue Sarcoma
- Keywords
- Soft Tissue Sarcoma, environment, pollutants, 04-088
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 8 Feb 2008 (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 purpose of this study is to assess the feasibility of conducting a large hospital based case control study of the role of dioxins and dioxinlike polychlorinated dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Soft Tissue Sarcoma at Memorial Sloan Kettering Cancer Center.
Key inclusion criteria (7 listed)
- Patients with Soft tissue sarcoma at MSKCC are eligible for this study if they meet the following criteria:
- Between 18 and 79 years of age
- were diagnosed within the previous 6 months with primary soft tissue sarcoma of one of the following histologic subtypes: liposarcoma, leiomyoscaroma, MFH, or synovial sarcoma
- are enrolled in protocol 02-060 ("Novel Biochemical and Molecularr Determinants for Soft Tissue Sarcoma"; PI, Dr. Samuel Singer)
- controls will be eligibile for this study if they meet the following criteria
Key exclusion criteria (3 listed)
- Individuals will be excluded if they
- are unable to sign informed consent for medical or other reasons
- do not speak english
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
enrollment of 60 participants
Time frame: Conclusion of the study
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 20 Jan 2011.
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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.
Lawrence Engel, Ph.D. principal investigator
Memorial Sloan Kettering Cancer 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 Soft Tissue Sarcoma, run by Memorial Sloan Kettering Cancer Center 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 7 inclusion and 3 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 20 Jan 2011. 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.
What does the primary outcome measure?
enrollment of 60 participants (time frame: Conclusion of the study). It is what the study was designed to measure, not a finding.
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 20 Jan 2011.