SarcomaNCT00900341
Studying Tumor Tissue Samples From Patients With Soft Tissue Sarcoma
An observational study of Sarcoma, run by University of Arizona at 1 site in United States.
Trial summary
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at tumor tissue samples from patients with soft tissue sarcoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma
- What is being tested?
- DNA analysis, gene expression analysis and protein expression analysis
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Jun 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing surgical treatment for soft tissue sarcomas removal or core needle biopsy for medically indicated diagnostic or therapeutic purposes.
DISEASE CHARACTERISTICS:
- Meets one of the following criteria:
- Patients with soft tissue sarcoma (STS) undergoing evaluation, treatment, and/or follow-up at the Arizona Cancer Center or University Medical Center
- Patients undergoing surgical treatment for STS removal or core needle biopsy for medically indicated diagnostic or therapeutic purposes
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724-5024
About this study
Official title: LABORATORY STUDIES OF SOFT TISSUE SARCOMAS
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at tumor tissue samples from patients with soft tissue sarcoma.
Read the detailed description
OBJECTIVES:
- To develop a pilot program for the collection, archiving, and experimental analyses of soft tissue sarcomas (STS).
- To obtain STS tumors from cancer patients undergoing tumor removal or core needle biopsies.
- To evaluate cellular and molecular factors involved in STS oncogenesis by studying samples derived from human tumor specimens.
- To develop an accompanying bioinformatics database of the demographics of STS patients from which tumor specimens are derived for experimental study.
OUTLINE: Tumor tissue samples are analyzed for gene and protein expression by cDNA microarray analysis, RT-PCR, immunohistochemistry, in vitro transformation assays, RNA interference, and Western blot or immunoprecipitation.
- Conditions
- Sarcoma
- Being tested
- DNA analysis, gene expression analysis, protein expression analysis, reverse transcriptase-polymerase chain reaction, western blotting
- Keywords
- adult soft tissue sarcoma, childhood soft tissue sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
gene expression analysisGenetic
protein expression analysisGenetic
reverse transcriptase-polymerase chain reactionGenetic
western blottingGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of molecular targets that would improve the diagnosis, prognosis, and/or treatment of STS
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startAug 2005
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lee D. Cranmer, MD, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900341
- Sponsor's protocol ID
- 05-0509-04
- Other IDs
- P30CA023074, UARIZ-HSCA0535, UARIZ-17879
- Status last verified
- Mar 2014
- First submitted
- 9 May 2009
- Last updated
- 21 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LABORATORY STUDIES OF SOFT TISSUE SARCOMAS
- ClinicalTrials.gov ID
- NCT00900341
- Acronym / sponsor ID
- 05-0509-04
- Conditions
- Sarcoma
- Keywords
- adult soft tissue sarcoma, childhood soft tissue sarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2005
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 May 2009 (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.
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at tumor tissue samples from patients with soft tissue sarcoma.
Detailed description
OBJECTIVES:
- To develop a pilot program for the collection, archiving, and experimental analyses of soft tissue sarcomas (STS).
- To obtain STS tumors from cancer patients undergoing tumor removal or core needle biopsies.
- To evaluate cellular and molecular factors involved in STS oncogenesis by studying samples derived from human tumor specimens.
- To develop an accompanying bioinformatics database of the demographics of STS patients from which tumor specimens are derived for experimental study.
OUTLINE: Tumor tissue samples are analyzed for gene and protein expression by cDNA microarray analysis, RT-PCR, immunohistochemistry, in vitro transformation assays, RNA interference, and Western blot or immunoprecipitation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing surgical treatment for soft tissue sarcomas removal or core needle biopsy for medically indicated diagnostic or therapeutic purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA analysis | Genetic | – |
| gene expression analysis | Genetic | – |
| protein expression analysis | Genetic | – |
| reverse transcriptase-polymerase chain reaction | Genetic | – |
| western blotting | Genetic | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Identification of molecular targets that would improve the diagnosis, prognosis, and/or treatment of STS
Time frame: 3 months
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 Mar 2014.
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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.
Lee D. Cranmer, MD, PhD principal investigator
University of Arizona
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 Sarcoma, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2014. 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?
Identification of molecular targets that would improve the diagnosis, prognosis, and/or treatment of STS (time frame: 3 months). 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 Mar 2014.