Endometrial AdenocarcinomaNCT01208467
Prognostic Biomarkers in Patients With Endometrial Cancer
An observational study of Endometrial Adenocarcinoma and Recurrent Uterine Corpus Carcinoma, run by Gynecologic Oncology Group at 1 site in United States.
Trial summary
This research study is studying prognostic biomarkers in tissue samples from patients with endometrial cancer. Studying samples of 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Adenocarcinoma, Recurrent Uterine Corpus Carcinoma, Stage I Uterine Corpus Cancer
- What is being tested?
- Laboratory Biomarker Analysis
- How many people
- 2,824 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to May 2014
- 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
Study population: Patients with endometrial cancer
Who may be able to join
- Women who were eligible and evaluable for the GOG-0210 molecular staging protocol in women with endometrial cancer
- Women who were registered during the unrestricted enrollment period (through 9/23/07) will automatically qualify
- Women who were registered during the restricted enrollment period (after 9/23/07) will only be considered if needed
- Women who had histologically confirmed endometrioid endometrial adenocarcinoma regardless of stage or grade
- Women who have defective DNA mismatch repair and are microsatellite instability positive (MSI+ and MSI-low)
- Women who consented to allow their specimens and clinical data to be used for future cancer research
- Women who have sufficient high-quality genomic DNA from tumor available for mutation analysis of ATR
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103
About this study
Official title: Validating The Prognostic Role of ATR Mutation in Patients With Endometrioid Endometrial Cancer
This research study is studying prognostic biomarkers in tissue samples from patients with endometrial cancer. Studying samples of 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.
Read the detailed description
PRIMARY OBJECTIVES:
- To validate the clinicopathologic associations and prognostic significance of ATR mutation in endometrioid endometrial cancer cases with defective DNA mismatch repair.
OUTLINE: This is a multicenter study.
DNA extracted from previously collected tumor samples is analyzed to validate the clinicopathologic associations and prognostic significance of ATR mutation.
- Conditions
- Endometrial Adenocarcinoma, Recurrent Uterine Corpus Carcinoma, Stage I Uterine Corpus Cancer, Stage II Uterine Corpus Cancer, Stage III Uterine Corpus Cancer, Stage IV Uterine Corpus Cancer
- Being tested
- Laboratory Biomarker Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Basic science (DNA analysis) | DNA extracted from previously collected tumor samples is analyzed to validate the clinicopathologic associations and prognostic significance of ATR mutation. Receives: Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
ATR mutation status
Parametric and non-parametric statistical tests will be performed to evaluate the association between ATR mutation status and demographic and clinical data. Product-limit estimates according to Kaplan-Meier method will be calculated and difference between survival according to ATR mutation status will be assessed using a two sided log rank test. The predictive ability of the final model will be assessed using a concordance index (C-statistic).
Measured: 1 month
Microsatellite instability (MSI)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial AdenocarcinomaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,824 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Israel Zighelboim, Principal investigator, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208467
- Sponsor's protocol ID
- GOG-8017
- Other IDs
- NCI-2011-02870, GOG-8017, CDR0000685834, GOG-8017, GOG-8017, U10CA027469
- Status last verified
- Aug 2017
- First submitted
- 23 Sep 2010
- Last updated
- 23 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating The Prognostic Role of ATR Mutation in Patients With Endometrioid Endometrial Cancer
- ClinicalTrials.gov ID
- NCT01208467
- Acronym / sponsor ID
- GOG-8017
- Conditions
- Endometrial Adenocarcinoma, Recurrent Uterine Corpus Carcinoma, Stage I Uterine Corpus Cancer, Stage II Uterine Corpus Cancer, Stage III Uterine Corpus Cancer, Stage IV Uterine Corpus Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,824 participants (estimated)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2010 (actual)
- Primary completion
- May 2014 (actual)
- First posted
- 24 Sep 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.
This research study is studying prognostic biomarkers in tissue samples from patients with endometrial cancer. Studying samples of 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.
Detailed description
PRIMARY OBJECTIVES:
- To validate the clinicopathologic associations and prognostic significance of ATR mutation in endometrioid endometrial cancer cases with defective DNA mismatch repair.
OUTLINE: This is a multicenter study.
DNA extracted from previously collected tumor samples is analyzed to validate the clinicopathologic associations and prognostic significance of ATR mutation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic science (DNA analysis) | – | Other: Laboratory Biomarker AnalysisDNA extracted from previously collected tumor samples is analyzed to validate the clinicopathologic associations and prognostic significance of ATR mutation. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with endometrial cancer
Key inclusion criteria (7 listed)
- Women who were eligible and evaluable for the GOG-0210 molecular staging protocol in women with endometrial cancer
- Women who had histologically confirmed endometrioid endometrial adenocarcinoma regardless of stage or grade
- Women who have defective DNA mismatch repair and are microsatellite instability positive (MSI+ and MSI-low)
- Women who consented to allow their specimens and clinical data to be used for future cancer research
- Women who have sufficient high-quality genomic DNA from tumor available for mutation analysis of ATR
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Basic science (DNA analysis) |
Primary outcome
ATR mutation status
Time frame: 1 month
Parametric and non-parametric statistical tests will be performed to evaluate the association between ATR mutation status and demographic and clinical data. Product-limit estimates according to Kaplan-Meier method will be calculated and difference between survival according to ATR mutation status will be assessed using a two sided log rank test. The predictive ability of the final model will be assessed using a concordance index (C-statistic).
Microsatellite instability (MSI)
Time frame: 1 month
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 Aug 2017.
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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.
Israel Zighelboim principal investigator
Gynecologic Oncology Group
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 Endometrial Adenocarcinoma and Recurrent Uterine Corpus Carcinoma, run by Gynecologic Oncology Group 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 0 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 Aug 2017. 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?
ATR mutation status (time frame: 1 month). The study lists 2 primary outcomes in all. 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 23 Aug 2017.