NCT00340808

Molecular Staging of Endometrial Cancer

Completed Last updated 17 July 2020

What this trial tests

trial in Endometrial Cancer in 5,492 participants. Completed in 16 July 2020.

Timeline

19 March 2004

Primary endpoint
30 June 2020

16 July 2020

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	5,492
Start date	19 March 2004
Primary completion	30 June 2020
Estimated completion	16 July 2020
Sites	1 location across United States

Conditions studied

• Endometrial Cancer — all drugs for Endometrial Cancer →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, female only, with Endometrial Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinicopathologic Significance of Mismatch Repair Defects in Endometrial Cancer: An NRG Oncology/Gynecologic Oncology Group Study.
   McMeekin DS, Tritchler DL, Cohn DE, Mutch DG, et al · · 2016 · cited 147× · PMID 27325856 · DOI 10.1200/jco.2016.67.8722
2. 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.
   Goodfellow PJ, Billingsley CC, Lankes HA, Ali S, et al · · 2015 · cited 140× · PMID 26552419 · DOI 10.1200/jco.2015.63.9518
3. An NRG Oncology/GOG study of molecular classification for risk prediction in endometrioid endometrial cancer.
   Cosgrove CM, Tritchler DL, Cohn DE, Mutch DG, et al · · 2018 · cited 100× · PMID 29132872 · DOI 10.1016/j.ygyno.2017.10.037
4. Overexpression of enhance of Zeste homolog 2 (EZH2) in endometrial carcinoma: An NRG Oncology/Gynecologic Oncology Group Study.
   Krill L, Deng W, Eskander R, Mutch D, et al · · 2020 · cited 25× · PMID 31843273 · DOI 10.1016/j.ygyno.2019.12.003
5. Nonsteroidal Anti-inflammatory Drugs and Endometrial Carcinoma Mortality and Recurrence.
   Brasky TM, Felix AS, Cohn DE, McMeekin DS, et al · · 2017 · cited 25× · PMID 28376204 · DOI 10.1093/jnci/djw251
6. Associations between etiologic factors and mortality after endometrial cancer diagnosis: the NRG Oncology/Gynecologic Oncology Group 210 trial.
   Felix AS, Scott McMeekin D, Mutch D, Walker JL, et al · · 2015 · cited 24× · PMID 26341710 · DOI 10.1016/j.ygyno.2015.08.022
7. Receipt of adjuvant endometrial cancer treatment according to race: an NRG Oncology/Gynecologic Oncology Group 210 Study.
   Felix AS, Cohn DE, Brasky TM, Zaino R, et al · · 2018 · cited 14× · PMID 30096321 · DOI 10.1016/j.ajog.2018.08.002
8. Sex Hormones, Insulin, and Insulin-like Growth Factors in Recurrence of High-Stage Endometrial Cancer.
   Merritt MA, Strickler HD, Hutson AD, Einstein MH, et al · · 2021 · cited 12× · PMID 33622671 · DOI 10.1158/1055-9965.epi-20-1613