Stage I Uterine Corpus CancerNCT01198171
Racial and Genetic Biomarkers of Response in Tissue Samples From Patients With Endometrial Cancer
An observational study of Stage I Uterine Corpus Cancer and Stage II Uterine Corpus Cancer, run by Gynecologic Oncology Group at 1 site in United States.
Trial summary
This research study is studying racial and genetic biomarkers of response 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
- Stage I Uterine Corpus Cancer, Stage II Uterine Corpus Cancer, Stage III Uterine Corpus Cancer
- What is being tested?
- Laboratory Biomarker Analysis and Study of Socioeconomic and Demographic Variables
- How many people
- 243 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Feb 2017
- 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: Patient with endometrial cancer
Who may be able to join
- Histologically confirmed endometrial cancer
- Stage I-IV disease regardless of grade
- Underwent surgical staging including hysterectomy, bilateral oophorectomy, washings, and pelvic lymphadenectomy
- Eligible and evaluated on GOG-0210 clinical trial, a Molecular Staging Study in Endometrial Cancer
- Available frozen or formalin-fixed and paraffin-embedded normal tissue that is free of tumor cells and yields sufficient high-quality normal DNA for testing
- Consented their specimens and clinical data to be collected and used in future studies
- Self-declared African-American or Caucasian race
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: The Relationship of Racial Genetic Admixture With Endometrial Cancer Outcomes
This research study is studying racial and genetic biomarkers of response 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. DNA analysis of tumor tissue may also help doctors predict how well patients will respond to treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- To identify racial categorization as the proportion of genetic background of African-American or European-American women with endometrioid endometrial cancer (EEC).
II. To evaluate the association of racial genetic admixture with clinicopathologic variables and outcomes.
SECONDARY OBJECTIVES:
- To compare the concordance between racial genetic admixture and self-designated race categorization.
OUTLINE: This is a multicenter study. Patients are stratified by race (African-American vs European-American) and disease stage (I vs II vs III vs IV).
DNA from archived frozen normal tissue samples is genotyped for the ancestry informative markers. Clinicopathological and demographic characteristics associated with each sample are also collected.
- Conditions
- 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, Study of Socioeconomic and Demographic Variables
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 of Socioeconomic and Demographic VariablesOther
| Study group | Role | What they receive |
|---|---|---|
| Basic science (DNA analysis) | DNA from archived frozen normal tissue samples is genotyped for the ancestry informative markers. Clinicopathological and demographic characteristics associated with each sample are also collected. Receives: Other: Laboratory Biomarker Analysis; Other: Study of Socioeconomic and Demographic Variables |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinicopathologic and demographic characteristics: characteristics: self-reported race, stage, age, race, parity, body-mass index, stage, grade, depth of invasion, lymph-vascular space invasion, and metastasis
Measured: 1 year
Overall survival
Measured: 1 year
Progression-free survival
Measured: 1 year
Proportion of genetic background that is of African-American descent
Measured: 1 year
Secondary outcomes (1)
Racial genetic admixture score, summarized by race and other clinicopathologic variables
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Uterine Corpus 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
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rodney Rocconi, Principal investigator, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198171
- Sponsor's protocol ID
- GOG-8022
- Other IDs
- NCI-2011-02867, CDR0000684547, GOG-8022, GOG-8022, GOG-8022, P50CA134254, R01CA071754, R21CA133295
- Status last verified
- Aug 2024
- First submitted
- 8 Sep 2010
- Last updated
- 14 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Racial Genetic Admixture With Endometrial Cancer Outcomes
- ClinicalTrials.gov ID
- NCT01198171
- Acronym / sponsor ID
- GOG-8022
- Conditions
- 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
- 243 participants (actual)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2010 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 9 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 racial and genetic biomarkers of response 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. DNA analysis of tumor tissue may also help doctors predict how well patients will respond to treatment.
Detailed description
PRIMARY OBJECTIVES:
- To identify racial categorization as the proportion of genetic background of African-American or European-American women with endometrioid endometrial cancer (EEC).
II. To evaluate the association of racial genetic admixture with clinicopathologic variables and outcomes.
SECONDARY OBJECTIVES:
- To compare the concordance between racial genetic admixture and self-designated race categorization.
OUTLINE: This is a multicenter study. Patients are stratified by race (African-American vs European-American) and disease stage (I vs II vs III vs IV).
DNA from archived frozen normal tissue samples is genotyped for the ancestry informative markers. Clinicopathological and demographic characteristics associated with each sample are also collected.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic science (DNA analysis) | – | Other: Laboratory Biomarker Analysis, Other: Study of Socioeconomic and Demographic VariablesDNA from archived frozen normal tissue samples is genotyped for the ancestry informative markers. Clinicopathological and demographic characteristics associated with each sample are also collected. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with endometrial cancer
Key inclusion criteria (7 listed)
- Histologically confirmed endometrial cancer
- Eligible and evaluated on GOG-0210 clinical trial, a Molecular Staging Study in Endometrial Cancer
- Available frozen or formalin-fixed and paraffin-embedded normal tissue that is free of tumor cells and yields sufficient high-quality normal DNA for testing
- Consented their specimens and clinical data to be collected and used in future studies
- Self-declared African-American or Caucasian race
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) |
| Study of Socioeconomic and Demographic Variables | Other | Basic science (DNA analysis) |
Primary outcome
Clinicopathologic and demographic characteristics: characteristics: self-reported race, stage, age, race, parity, body-mass index, stage, grade, depth of invasion, lymph-vascular space invasion, and metastasis
Time frame: 1 year
Overall survival
Time frame: 1 year
Progression-free survival
Time frame: 1 year
Proportion of genetic background that is of African-American descent
Time frame: 1 year
1 secondary outcome
Racial genetic admixture score, summarized by race and other clinicopathologic variables
Time frame: 1 year
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 14 Aug 2024.
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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.
Rodney Rocconi 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 Stage I Uterine Corpus Cancer and Stage II Uterine Corpus Cancer, 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 14 Aug 2024. 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?
Clinicopathologic and demographic characteristics: characteristics: self-reported race, stage, age, race, parity, body-mass index, stage, grade, depth of invasion, lymph-vascular space invasion, and metastasis (time frame: 1 year). The study lists 4 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 14 Aug 2024.