- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00340808
Molecular Staging of Endometrial Cancer
Integration of an Epidemiologic Questionnaire Into Gynecologic Oncology Group Trials: First Project, Protocol 210
This study, sponsored by NCI and the Gynecologic Oncology Group (GOG), will collect tissue samples from women with cancer of the endometrium (lining of the uterus). Researchers will use the samples to learn more about endometrial cancer and develop new treatments and methods of prevention.
Women with endometrial cancer who are suitable candidates for surgery and who have not had prior retroperitoneal surgery or pelvic or abdominal radiation therapy may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, and endometrial biopsy (surgical removal of a small tissue sample) or dilation and curettage (D & C).
Participants will undergo hysterectomy (surgery to remove the uterus) along with removal of both fallopian tubes and ovaries. This is the standard surgical treatment for endometrial cancer. Lymph nodes in the pelvis near the main blood vessel in the abdomen are also removed to determine if the disease has spread to these nodes. If cancer is found involving other sites, the cancer in those areas may also be removed; examination of the tissues will determine if further therapy beyond surgery is needed.
Before surgery, patients will complete a 20-minute questionnaire that includes questions about their background, reproductive history, menstruation and menopause, certain surgeries, birth control pills and hormone replacement therapy, other drugs and medicines, weight and height, smoking, medical history, and family history of cancer.
Some of the tissue removed during surgery, plus a urine sample collected from a catheter bag during surgery, and blood drawn before surgery and at follow-up visits 6 weeks and 3 years after surgery, will be sent to the GOG Tissue Bank in Columbus, Ohio. This bank stores, processes, and distributes biological specimens from patients that agree to participate in studies conducted by the GOG.
Patients will have follow-up visits 6 weeks after surgery, then every 6 months for the next 2 years, followed annually for the next 7 years, for a total 10-year follow-up. The visits will include an examination and questions about health status and treatments received between visits. Patients whose cancer returns or worsens will undergo another tumor biopsy, if possible, at that time.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oklahoma
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Norman, Oklahoma, United States, 73019
- University of Oklahoma
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
- Patients with endometrial carcinoma diagnosed by an endometrial biopsy or dilation and curettage who will undergo full surgical staging; all stages, grades and histologic subtypes will be eligible.
- Patients must be suitable candidates for surgery. Patients may also be entered on GOG-2222 (LAP2).
- Patients who have signed an approved Informed Consent.
- Patients who have met the pre-entry requirements specified in the Study Parameters.
- Patients with a prior malignancy (at least 5 years since diagnosis) with no current evidence of disease.
EXCLUSION CRITERIA:
- Patients not considered suitable candidates for surgery.
- Patients who have had prior retroperitoneal surgery.
- Patients who have received prior pelvic or abdominal radiation therapy.
- Patients who are pregnant.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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endometrial cancer cases
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Breast, colorectal, endometrial, and ovarian cancers
Time Frame: Baseline 1992-1993 with 10 years of follow-up (1992-2003)
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Baseline 1992-1993 with 10 years of follow-up (1992-2003)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Britton L Trabert, Ph.D., National Cancer Institute (NCI)
Publications and helpful links
General Publications
- Hagemann IS, Deng W, Zaino RJ, Powell MA, Gunderson C, Cosgrove C, Mathews C, Pearl ML, Waggoner S, Ghebre R, Lele S, Guntupalli S, Secord AA, Ioffe O, Park K, Rasty G, Singh M, Soslow R, Creasman W, Mutch DG. The presence of an endometrioid component does not alter the clinicopathologic profile or survival of patients with uterine serous cancer: A gynecologic oncology group (GOG/NRG) study of 934 women. Gynecol Oncol. 2021 Mar;160(3):660-668. doi: 10.1016/j.ygyno.2020.12.040. Epub 2021 Jan 8.
- Krill L, Deng W, Eskander R, Mutch D, Zweizig S, Hoang B, Ioffe O, Randall L, Lankes H, Miller DS, Birrer M. Overexpression of enhance of Zeste homolog 2 (EZH2) in endometrial carcinoma: An NRG Oncology/Gynecologic Oncology Group Study. Gynecol Oncol. 2020 Feb;156(2):423-429. doi: 10.1016/j.ygyno.2019.12.003. Epub 2019 Dec 13.
- McMeekin DS, Tritchler DL, Cohn DE, Mutch DG, Lankes HA, Geller MA, Powell MA, Backes FJ, Landrum LM, Zaino R, Broaddus RD, Ramirez N, Gao F, Ali S, Darcy KM, Pearl ML, DiSilvestro PA, Lele SB, Goodfellow PJ. Clinicopathologic Significance of Mismatch Repair Defects in Endometrial Cancer: An NRG Oncology/Gynecologic Oncology Group Study. J Clin Oncol. 2016 Sep 1;34(25):3062-8. doi: 10.1200/JCO.2016.67.8722. Epub 2016 Jun 20.
- Goodfellow PJ, Billingsley CC, Lankes HA, Ali S, Cohn DE, Broaddus RJ, Ramirez N, Pritchard CC, Hampel H, Chassen AS, Simmons LV, Schmidt AP, Gao F, Brinton LA, Backes F, Landrum LM, Geller MA, DiSilvestro PA, Pearl ML, Lele SB, Powell MA, Zaino RJ, Mutch D. Combined Microsatellite Instability, MLH1 Methylation Analysis, and Immunohistochemistry for Lynch Syndrome Screening in Endometrial Cancers From GOG210: An NRG Oncology and Gynecologic Oncology Group Study. J Clin Oncol. 2015 Dec 20;33(36):4301-8. doi: 10.1200/JCO.2015.63.9518. Epub 2015 Nov 9.
- Felix AS, Scott McMeekin D, Mutch D, Walker JL, Creasman WT, Cohn DE, Ali S, Moore RG, Downs LS, Ioffe OB, Park KJ, Sherman ME, Brinton LA. Associations between etiologic factors and mortality after endometrial cancer diagnosis: the NRG Oncology/Gynecologic Oncology Group 210 trial. Gynecol Oncol. 2015 Oct;139(1):70-6. doi: 10.1016/j.ygyno.2015.08.022. Epub 2015 Sep 1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999904144
- 04-C-N144
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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