Endometrial CancerNCT01119573
Biomarkers in Tissue Samples From Patients With Stage I or Stage III Endometrial Cancer
An observational study of Endometrial Cancer, run by Gynecologic Oncology Group.
Trial summary
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This research study is studying at biomarkers in tissue samples from patients with stage I or stage III endometrial cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- RNA analysis, microarray analysis and reverse transcriptase-polymerase chain reaction
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Jun 2010
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed endometrioid endometrial cancer
- Stage IA, IB, IC, or IIIC disease
- Any grade
- Enrolled and evaluated on GOG-0210 Molecular Staging Study of Endometrial Cancer
- Consented to allow their specimens and clinical data to be collected and stored for future research
- Underwent complete surgical staging, including the following:
- Hysterectomy
- Bilateral oophorectomy
- Washings as well as pelvic lymphadenectomy (sampling of four left and four right pelvic lymph nodes)
- Para-aortic lymphadenectomy (sampling of one left and one right para-aortic lymph node)
- Sufficient high-quality frozen primary tumor for testing with ≥ 75% tumor cellularity and ≤ 10% necrosis
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Micro RNA's Associated With Lymph Node Metastasis in Endometrial Cancer
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is studying at biomarkers in tissue samples from patients with stage I or stage III endometrial cancer.
Read the detailed description
OBJECTIVES:
- To identify microRNA expression patterns associated with lymph node metastasis in samples from patients with endometrial cancer.
OUTLINE: Banked tumor tissue specimens are analyzed for microRNA expression profiling by microarray analysis and reverse transcriptase-PCR assays.
- Conditions
- Endometrial Cancer
- Being tested
- RNA analysis, microarray analysis, reverse transcriptase-polymerase chain reaction, laboratory biomarker analysis
- Keywords
- stage I endometrial carcinoma, stage III endometrial carcinoma
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNA analysisGenetic
microarray analysisGenetic
reverse transcriptase-polymerase chain reactionGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between microRNA expression and lymph node metastasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies 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
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- David S. Miller, MD, Principal investigator, Simmons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119573
- Sponsor's protocol ID
- CDR0000672415
- Other IDs
- GOG-8014
- Status last verified
- May 2010
- First submitted
- 6 May 2010
- Last updated
- 22 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro RNA's Associated With Lymph Node Metastasis in Endometrial Cancer
- ClinicalTrials.gov ID
- NCT01119573
- Acronym / sponsor ID
- CDR0000672415
- Conditions
- Endometrial Cancer
- Keywords
- stage I endometrial carcinoma, stage III endometrial carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2010
- Primary completion
- Jun 2010 (estimated)
- First posted
- 7 May 2010 (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 identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is studying at biomarkers in tissue samples from patients with stage I or stage III endometrial cancer.
Detailed description
OBJECTIVES:
- To identify microRNA expression patterns associated with lymph node metastasis in samples from patients with endometrial cancer.
OUTLINE: Banked tumor tissue specimens are analyzed for microRNA expression profiling by microarray analysis and reverse transcriptase-PCR assays.
Study design
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| RNA analysis | Genetic | – |
| microarray analysis | Genetic | – |
| reverse transcriptase-polymerase chain reaction | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Association between microRNA expression and lymph node metastasis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
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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 S. Miller, MD principal investigator
Simmons Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Gynecologic Oncology Group.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Association between microRNA expression and lymph node metastasis. 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 22 Jun 2010.