The Accuracy of Host DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening: a Multi-center, Double-blind, Parallel Controlled Clinical Trials
Based on the previous study of NCT04651738, we performed this trial to further confirm the accuracy of host DNA CDO1 and CELF4 methylation for endometrial cancer screening. This study would provide profound basis for the approval of assay kit of DNA methylation in China for endometrial screening. Four hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA CDO1 and CELF4 methylation, and the results will compared with the endometrial histological pathology, which is achieved after collection of cervical cytology, by surgeries including hysteroscopy, dilation and curettage, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The study will enroll at least 7150 patients.
NCT05290922 — Endometrial Cancer
Status: Recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT05290922/
The Accuracy of Host DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening: a Multi-center Cohort Study
Based on the previous study of NCT04651738, we performed this trial to further confirm the accuracy of host DNA CDO1 and CELF4 methylation for endometrial cancer screening in a multi-center cohort. Thirteen hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA CDO1 and CELF4 methylation, and the results will compared with the endometrial histological pathology, which is achieved after collection of cervical cytology, by surgeries including hysteroscopy, dilation and curettage, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The study will enroll at least 10,000 patients.
NCT05290415 — Endometrial Cancer
Status: Recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT05290415/
The Molecular and the Clinical Effects of Preoperative Niraparib in Patients With High-grade Endometrial Cancer: Phase 0 Exploratory Trial
The study will investigate the effect of niraparib on tumor tissue in chemotherapy naïve, newly diagnosed, high-grade endometrial cancer patients. Biomarkers of cognate molecular pathways as well as investigational assays will be used to study the antineoplastic effect of the drug.
NCT05289648 — Endometrial Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT05289648/
A Multicenter, Open-Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib in Combination With Pembrolizumab in Black Participants With Mismatch Repair-Proficient Recurrent Endometrial Cancer
Determine the efficacy of the combination of lenvatinib and pembrolizumab in Black participants
NCT05263492 — Endometrial Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT05263492/
Frequency of Endometrial Cancer Precursors Associated With Lynch Syndrome
Given that there is a significant prevalence of Lynch syndrome among patients with endometrial cancer (about 5% of patients with endometrial cancer), and given there is a known risk of endometrial cancer among patients with endometrial hyperplasia (40% risk of pre-existing occult cancer with endometrial intraepithelial neoplasia), it is hypothesized that a diagnosis of endometrial hyperplasia may herald on-going risk of harboring a Lynch Syndrome gene mutation. The purpose of this study is to examine endometrial hyperplasia specimens and compare the frequency of Lynch Syndrome gene mutations between endometrial hyperplasia and endometrial cancer subjects. This will provide a rationale and opportunity for earlier screening, and reduce colon cancer morbidity and mortality secondary to the Lynch syndrome gene.
NCT05257057 — Endometrial Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT05257057/
Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features: the p53abn-RED Trial, the MMRd-GREEN Trial, the NSMP-ORANGE Trial and the POLEmut-BLUE Trial
The RAINBO umbrella program consists of four clinical trials investigating new adjuvant therapies in endometrial cancer patients. Eligible patients will be assigned to one of the four RAINBO trials based on the molecular profile of their cancer: - p53 abnormal endometrial cancer patients to the p53abn-RED trial - mismatch repair deficient endometrial cancer patients to the MMRd-GREEN trial - no specific molecular profile endometrial cancer patients to NSMP-ORANGE trial - POLE mutant endometrial cancer patients to the POLEmut-BLUE trial
NCT05255653 — Endometrial Cancer
Status: Recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT05255653/
Gonadotropin-releasing Hormone Agonist Combined With Letrozole Compared With Megestrol Acetate or Medroxyprogesterone Acetate Alone as Fertility-sparing Treatment in Early Endometrial Cancer
To see if Gonadotropin-releasing hormone analogue (GnRHa) combined with aromatase inhibitors (AIs) will achieve better complete response rate than megestrol acetate or medroxyprogesterone acetate (MA/MPA) alone as fertility-sparing treatment for patients with early endometrial carcinoma.
NCT05247268 — Endometrial Neoplasm Malignant Stage I
Status: Recruiting
http://inclinicaltrials.com/endometrial-neoplasm-malignant-stage-i/NCT05247268/
Vaginal Estradiol Tablets (Vagifem®) and Endometrial Cancer Risk in the Treatment of Postmenopausal Vaginal Atrophy: A Register-based Cohort Study in Postmenopausal Women
The study will include data from a nationwide Danish cohort of postmenopausal women and the United States of America (US) cohort of postmenopausal women. The Danish nationwide cohort will be established through linkage of Danish national patient registries. The US cohort will be established based on data from US claims database, Truven. The aim of this study is to evaluate whether exposure to Vagifem® increases the rate of endometrial cancer in postmenopausal women.
NCT05243823 — Postmenopausal Vaginal Atrophy
Status: Completed
http://inclinicaltrials.com/postmenopausal-vaginal-atrophy/NCT05243823/
A Prospective Study of the Impact of Uterine Manipulator on Oncological Outcome in Endometrial Cancer Surgery in Early-stage: Pro MUCEI Study
The uterine manipulator is a device commonly used in minimally invasive hysterectomy surgery for endometrial cancer. However, without substantial evidence to support its use, surgeons are required to make decisions about its use based only on their personal choice and surgical experience. A retrospective study demonstrated how uterine manipulator use in early-stage endometrial cancer (FIGO I-II) for minimally invasive surgery was associated with a worse oncologic outcome in patients with uterus-confined endometrial cancer (FIGO I-II) who underwent minimally invasive surgery. The main objective of this study is to prospectively confirm the results obtained retrospectively, assessing the relapse rate in these patients related to the use or not of a uterine manipulator during the endometrial surgery. Secondary, the presence of risk factors that contraindicate the use of the uterine manipulator will also be evaluated.
NCT05242276 — Endometrial Cancer
Status: Recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT05242276/
The Feasibly, Efficacy, and Acceptability of FitEx for Endometrial Cancer Survivors: A Pilot Randomized Controlled Trial of Walking With or Without Yoga
The purpose of this study is to determine whether a physical activity tracking program called FitEx would be useful to endometrial cancer survivors. Each interested endometrial cancer survivor will recruit 1 to 5 additional friends/family members to participate in the intervention with them, forming a team. Each team will be randomized to FitExEC (control group) that receives FitEx for endometrial cancer survivors, or FitExEC+yoga (experimental group) that receives FitEx for endometrial cancer survivors plus yoga cueing. FitExEC is based on FitEx, a program used to encourage adults to improve their fruit and vegetable intake while increasing their physical activity. FitEx works by having participants join a team with their friends and loved ones, so they can support one another in meeting their goals. In this study, teams of endometrial cancer survivors/support members will receive watches that track how much they walk. Each day, participants record how much exercise, how many fruits, and how many vegetables they've eaten that day for a total of 8 weeks. Participants will be encouraged to attend a virtual session 15 minutes per week that will focus on 1-mile worth of exercise points (all control) or 15 minutes of yoga (all experimental) followed by 15 minutes of support (endometrial cancer survivors only [control and experimental survivors in different groups]). Participation in the study lasts roughly 10 weeks, and participants will be followed for 6 months afterward. The investigators think that FitEx may help people with endometrial cancer improve their daily physical activity and slowly improve their health and quality of life. The investigators hypothesize this intervention is feasible and acceptable to Carilion Clinic endometrial cancer survivors.
NCT05233059 — Quality of Life
Status: Completed
http://inclinicaltrials.com/quality-of-life/NCT05233059/