Optimising Cardiovascular Health in Endometrial Cancer Survivors
Women successfully treated for endometrial cancer remain at higher risk of dying than women without a history of the disease, predominately due to an excess risk of cardiovascular disease. Our previous work has shown that endometrial cancer survivors are more likely to have undiagnosed and undertreated cardiovascular risk factors than the general population, despite being seen regularly by medical professionals. This study aims to determine the impact of optimising modifiable cardiovascular risk factors in endometrial cancer survivors on their quality of life and to identify barriers to lifestyle modifications.
NCT05216913 — Cardiovascular Diseases
Status: Active, not recruiting
http://inclinicaltrials.com/cardiovascular-diseases/NCT05216913/
Randomized Phase III Trial in MMR Deficient Endometrial Cancer Patients Comparing Chemotherapy Alone Versus Dostarlimab in First Line Advanced/Metastatic Setting
Phase 3, randomized, multicentre study to evaluate the efficacy and safety of dostarlimab versus carboplatin-paclitaxel in patients with MMR deficient relapse or advanced endometrial cancer.
NCT05201547 — Endometrial Cancer
Status: Recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT05201547/
Endometrial Cancer Recurrence in Patients Taking Metformin
Given the early literature available and its biological plausibility as an inhibitor of the mammalian target of rapamycin (mTOR) protein, it is hypothesized that women with endometrial cancer who take metformin for non-cancer related reasons have a lower cancer recurrence rate compared to women not taking metformin. The primary goal of this study is to determine whether metformin use is associated with a decrease in the rate of endometrial cancer recurrence. Secondary objectives are to assess whether women with endometrial cancer taking metformin have longer progression free survival and overall survival than those that do not take metformin.
NCT05192850 — Recurrent Endometrial Carcinoma
Status: Active, not recruiting
http://inclinicaltrials.com/recurrent-endometrial-carcinoma/NCT05192850/
The Role of Real-time Appearance of Lymphatic Flow in the Detection of Bilateral Sentinel Lymph Node With Fluorescence Imaging Technique in Endometrial Cancer
Purpose of the study Primary treatment of clinical early stage endometrial cancer is total hysterectomy, bilateral salpingo-oophorectomy, and lymph node dissection for staging. It was stated in the National Comprehensive Cancer Network (NCCN) guideline that sentinel lymph node biopsy can be performed as an alternative to systematic lymphadenectomy, including high-risk endometrial cancer histologies (2). In a study, the rate of bilateral sentinel lymph node detection in sentinel lymph node mapping using the cervical injection technique of indocyanine green was found to be 73.3%. After re-injection of cervical indocyanine green in patients whose sentinel lymph node could not be detected, the rate of detection of bilateral sentinel lymph nodes increased to 94.5% (4). However, repeated cervical injection causes a waste of time. In our clinic, sentinel lymph node mapping method is applied using indocyanine green for lymph node dissection for staging purposes, since the robotic system has a fluorescent imaging system in patients operated with robotic surgery for endometrial cancer. In accordance with the literature, our bilateral sentinel lymph node detection rate was 75%. During cervical indocyanine green injection in our last 6 patients, the lymphatic channels in the pelvic region were followed simultaneously with the injection and indocyanine injection was performed until the channels were seen transperitoneally. Bilateral lymphatic channels were seen in all of these patients, and sentinel lymph nodes were found bilaterally in all of them. The aim of the planned study is to compare the traditional cervical indocyanine green injection and indocyanine injection until the lymphatic channels are visualized for bilateral detection of sentinel lymph nodes in patients with clinical early stage endometrial cancer. Material-Method The number of patients planned to be included in the study was calculated as 24 patients in both groups, with an alpha error value of 5% and a statistical power above 80% when the bilateral sentinel lymph node detection rate was 75% in the traditional method and 99% in the study group (SPH analytics 2021).
NCT05191212 — Sentinel Lymph Node
Status: Recruiting
http://inclinicaltrials.com/sentinel-lymph-node/NCT05191212/
Randomized Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Therapy for Women With Early Stage Endometrioid Adenocarcinoma
This is a prospective, multicenter, randomized phase III trial among women with endometrioid adenocarcinoma with high-intermediate and intermediate risk features to investigate the role of integrated genomic-pathologic classification to determine if participants should receive no adjuvant therapy, vaginal brachytherapy, external beam radiotherapy or chemo-radiation therapy based on molecular features as compared to standard radiation therapy.
NCT05179447 — Endometrial Cancer Stage I
Status: Recruiting
http://inclinicaltrials.com/endometrial-cancer-stage-i/NCT05179447/
The Effect of Androgen Receptor Polymorphism on Endometrial Cancer Development, Progression, and Outcome
Endometrial tissue is a hormonal-dependent tissue in both pre- and postmenopausal period. The endometrial cells are expressing receptors for all sex hormones, mainly for estrogen, progesterone and androgens. The proper response of the endometrial cells on hormones is crucial for a well-balanced fluctuation of endometrial tissue. If, for any reason, these responses are altered, this may lead to benign or malignant lesions. The androgens, through their receptors, decrease the proliferation of the endometrial cells. After menopause, the number of androgens receptors (ARs) increases in proportion to estrogen receptors and this may lead to endometrial atrophy. If the functionality of ARs is decreased, the effect of estrogen increases and this may possibly lead to endometrial hyperplasia or to endometrial cancer. The AR gene is located on the X chromosome and consists of 8 exons. Genetic research has shown that on exon 1, there is an area of trinucleotide Cytosine- Adenosine- Guanin (CAG) repeats which controls the functionality of the receptor. The more CAG repeats, the less responsive the receptor. The goal of this research is to study the AR gene polymorphism and particularly the number of CAG repeats on exon 1, in patients with known endometrial pathology (benign and malignant). The results will be compared with a random sample of the general population without endometrial pathology.
NCT05157373 — Endometrial Disorder
Status: Not yet recruiting
http://inclinicaltrials.com/endometrial-disorder/NCT05157373/
Phase 2 Study of Alpelisib and Fulvestrant for PIK3CA-mutated Estrogen Receptor (ER)-Positive Endometrioid Endometrial Cancers
This is a 2 stage multi-center study designed to evaluate the efficacy of the combination of alpelisib and fulvestrant in patients with PIK3CA-mutated ER-positive endometrioid endometrial cancers by estimating the objective response rate (ORR). Treatment will continue until either unacceptable toxicity, progression of disease, or investigator/patient request for withdrawal.
NCT05154487 — Endometroid Endometrial Cancer
Status: Recruiting
http://inclinicaltrials.com/endometroid-endometrial-cancer/NCT05154487/
RT-PACE: A Pilot Study of Adjuvant Hypo-Fractionated Radiotherapy for Non-Metastatic Cervical and Endometrial Cancer
This clinical trial studies the feasibility of using hypo-fractionated radiotherapy for the treatment of cervical or endometrial cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
NCT05139368 — Endometrial Carcinoma
Status: Recruiting
http://inclinicaltrials.com/endometrial-carcinoma/NCT05139368/
SMARAGD - Clinical Research Platform on Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancer Treatment and Outcomes
The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with advanced or metastatic ovarian cancer (OC) or advanced or metastatic endometrial cancer (EC) in Germany.
NCT05129969 — Ovarian Cancer
Status: Recruiting
http://inclinicaltrials.com/ovarian-cancer/NCT05129969/
An Open-label, Multi-center, Multi-corhort Phase II Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer
This is an open-label, multi-center, multi-corhort Phase II study of Envafolimab alone or with Lenvatinib in patients with advanced endometrial cancer.The primary objective is to evaluate objective response rate of envafolimab alone or with lenvatinib.
NCT05112991 — Advanced Endometrial Cancer
Status: Recruiting
http://inclinicaltrials.com/advanced-endometrial-cancer/NCT05112991/