Kaposi's Sarcoma AIDS RelatedNCT00587912
AIDS and Cancer Specimen Bank (ACSB)
An observational study of Kaposi's Sarcoma AIDS Related and Kaposi's Sarcoma Classical, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to obtain clinical specimens from pathologists and physicians involved in the diagnosis and care of patients with AIDS and non-AIDS associated malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kaposi's Sarcoma AIDS Related, Kaposi's Sarcoma Classical, Non-Hodgkin's Lymphoma
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1997to Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The Source of specimens will include patients screened for participation on protocols conducted by the AIDS Malignancy Consortium, as well as other patients with HIV infection and cancer who are not eligible for participation in AMC trials, and patients without HIV who have malignancies associated with HIV or with immunosuppression.
Who may be able to join
- Patient > 18 years of age
- Suspected or confirmed AIDS-Associated malignancy with or without HIV infection
- Will obtain fresh tissue and/or biological fluids
- Patient signed the correct version of the informed consent
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to obtain clinical specimens from pathologists and physicians involved in the diagnosis and care of patients with AIDS and non-AIDS associated malignancies.
The National Cancer Institute has set up a Bank for tissues and biological fluids from HIVpositive and HIV-negative individuals in order to have specimens available for scientists studying malignancies associated with HIV disease.
Read the detailed description
The overall goal of the AIDS and Cancer Specimen Bank is to obtain clinical specimens from pathologists and physicians involved in the diagnosis and care of patients with AIDS and non- AIDS associated malignancies. These specimens will be banked and linked to a clinical data set so that experimental results obtained by analysis of specific specimens can be linked to relevant clinical data. Contents of the ACSB will be made available to researchers through an application to the National Cancer Institute. Strict patient confidentiality protection guidelines are in place for all specimens in the ACSB. The objective of this protocol is to obtain clinical specimens from potential participants in clinical trials conducted by the AIDS Malignancies Consortium, and from other patients with and without HIV infection, who have AIDS-Associated malignancies.
- Conditions
- Kaposi's Sarcoma AIDS Related, Kaposi's Sarcoma Classical, Non-Hodgkin's Lymphoma, HEMATOPOIETIC SYSTEM, Cancer, AIDS
- Keywords
- Kaposi's Sarcoma AIDS Related, Kaposi's Sarcoma Classical, Non-Hodgkin's Lymphoma, HEMATOPOIETIC SYSTEM, Cancer, AIDS
- Medical subject headings
- AIDS-related Kaposi sarcoma, Lymphoma, Non-Hodgkin, Neoplasms, Acquired Immunodeficiency Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify and improve access to tumor tissue, biological specimens, and associated clinical outcome data that could be utilized for research by the research community at-large on the pathogenesis of HIV and non-HIV associated malignancies.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startJun 1997
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kaposi's Sarcoma AIDS RelatedStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), George Washington University, University of Hawaii, University of California, San Francisco, Kaiser Permanente
- Investigators
- David Straus, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587912
- Sponsor's protocol ID
- 97-043
- Status last verified
- Apr 2011
- First submitted
- 24 Dec 2007
- Last updated
- 21 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIDS and Cancer Specimen Bank (ACSB)
- ClinicalTrials.gov ID
- NCT00587912
- Acronym / sponsor ID
- 97-043
- Conditions
- Kaposi's Sarcoma AIDS Related, Kaposi's Sarcoma Classical, Non-Hodgkin's Lymphoma, HEMATOPOIETIC SYSTEM, Cancer, AIDS
- Keywords
- Kaposi's Sarcoma AIDS Related, Kaposi's Sarcoma Classical, Non-Hodgkin's Lymphoma, HEMATOPOIETIC SYSTEM, Cancer, AIDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), George Washington University, University of Hawaii, University of California, San Francisco, Kaiser Permanente
- Study start
- Jun 1997
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 8 Jan 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 obtain clinical specimens from pathologists and physicians involved in the diagnosis and care of patients with AIDS and non-AIDS associated malignancies.
The National Cancer Institute has set up a Bank for tissues and biological fluids from HIVpositive and HIV-negative individuals in order to have specimens available for scientists studying malignancies associated with HIV disease.
Detailed description
The overall goal of the AIDS and Cancer Specimen Bank is to obtain clinical specimens from pathologists and physicians involved in the diagnosis and care of patients with AIDS and non- AIDS associated malignancies. These specimens will be banked and linked to a clinical data set so that experimental results obtained by analysis of specific specimens can be linked to relevant clinical data. Contents of the ACSB will be made available to researchers through an application to the National Cancer Institute. Strict patient confidentiality protection guidelines are in place for all specimens in the ACSB. The objective of this protocol is to obtain clinical specimens from potential participants in clinical trials conducted by the AIDS Malignancies Consortium, and from other patients with and without HIV infection, who have AIDS-Associated malignancies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Source of specimens will include patients screened for participation on protocols conducted by the AIDS Malignancy Consortium, as well as other patients with HIV infection and cancer who are not eligible for participation in AMC trials, and patients without HIV who have malignancies associated with HIV or with immunosuppression.
Key inclusion criteria (4 listed)
- Patient > 18 years of age
- Suspected or confirmed AIDS-Associated malignancy with or without HIV infection
- Will obtain fresh tissue and/or biological fluids
- Patient signed the correct version of the informed consent
Key exclusion criteria (1 listed)
- N/A
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
Identify and improve access to tumor tissue, biological specimens, and associated clinical outcome data that could be utilized for research by the research community at-large on the pathogenesis of HIV and non-HIV associated malignancies.
Time frame: 3 years
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 21 Apr 2011.
- Memorial Sloan-Kettering web siteLink provided by the sponsor.
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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.
David Straus, MD 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 Kaposi's Sarcoma AIDS Related and Kaposi's Sarcoma Classical, 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 4 inclusion and 1 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 21 Apr 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?
Identify and improve access to tumor tissue, biological specimens, and associated clinical outcome data that could be utilized for research by the research community at-large on the pathogenesis of HIV and non-HIV associated malignancies. (time frame: 3 years). 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 21 Apr 2011.