Feasibility and Acceptability of Time Restricted Eating (TRE) Among Native Hawaiian/Pacific Islander Women at Risk for Endometrial Cancer
The long-term goal of this study is to determine the efficacy of time restricted eating (TRE) for improving metabolic health and preventing endometrial cancer. The primary objective of the protocol is to conduct a 14-week two-arm randomized crossover trial of a dietary intervention to evaluate the feasibility, fidelity and preliminary acceptability of a TRE intervention among Native Hawaiian/Pacific Islander women at risk for developing endometrial cancer, and to provide proof of principle that TRE can improve metabolic health in this population.
NCT04763902 — Endometrial Neoplasms
Status: Completed
http://inclinicaltrials.com/endometrial-neoplasms/NCT04763902/
A Phase II Clinical Trial Evaluating the Combination of Onapristone With Anastrozole for Women With Refractory Hormone Receptor Positive Endometrial Cancer
This phase II trial studies the effect of onapristone and anastrozole in treating patients with hormone receptor positive endometrial cancer that has not responded to previous treatment (refractory). Progesterone and estrogen are hormones that can cause the growth of endometrial cancer cells. Onapristone blocks the use of progesterone by the tumor cells. Anastrozole is a drug that blocks the production of estrogen in the body. Giving onapristone with anastrozole may work better than anastrozole alone in treating patients with hormone receptor positive endometrial cancer.
NCT04719273 — Refractory Endometrial Carcinoma
Status: Active, not recruiting
http://inclinicaltrials.com/refractory-endometrial-carcinoma/NCT04719273/
Tailored Adjuvant Therapy in POLE-mutated and p53-wildtype Early Stage Endometrial Cancer
Endometrial cancer(EC) is the 4th most common cancer in women globally. Clinicians struggle to determine 'the best' treatment for endometrial cancers as they are very hard to tell apart under the microscope. Our BC team developed and validated a low-cost practical tool that can reliably distinguish ECs by molecular features. Molecular classification can inform women about the likelihood of their disease coming back as well as which treatments might work best for them or are not needed. Investigators are studying how this classifier can identify women at very low risk of disease recurrence in order to spare them toxic therapies.
NCT04705649 — Endometrial Cancer
Status: Completed
http://inclinicaltrials.com/endometrial-cancer/NCT04705649/
Adipocytokines and Their Relationship to Obesity and Endometrial Cancer
The number of women diagnosed with uterine cancer continues to rise each year. Since the early 1990s, there has been almost 55% rise in the United Kingdom (UK). 34% of endometrial cancer can be attributed to obesity. In the obese state, the function of adipose tissue deteriorates resulting in a state of chronic inflammation. Adipocytokine-related signalling pathways promote cancer development by causing inflammation, cell proliferation, DNA damage and by inhibiting apoptosis. The investigators postulate that adipocytokines levels are significantly different in uterine cancer patients of different weight categories and different grade/stage/ type of tumour. Any woman attending the hospital with endometrial cancer and receiving treatment here will be invited to participate in the study. Consent will be sought to obtain 30mls (2 1/2 tablespoons) of venous blood at the time of surgery, on day 1 post-surgery and 3/6 months post-surgery during routine follow-up to check biomarker (adiponectin, leptin, tumour necrosis factor alpha, interleukin-6, Insulin-like growth factors 1 and 2) levels to see if the markers can be used to assess response to treatment. The investigators will also get consent to collect tissue - adipose tissue (after surgery) and uterine cancer tissue and lymph nodes (after histo-pathological evaluation) to assess for biomarkers. The investigators will also obtain blood samples from patients undergoing chemotherapy for advanced stage endometrial. All tissues procured will be anonymised and analysed at the oncology laboratory, Leggett building, University of Surrey and later correlated with patients' medical data as well as with tumour grade, stage and type. The investigators will also use archival tissue blocks stored at the same laboratory for analysis (previously consented for use in research). These are anonymised tissue and there is no link to patients' data. The aim would be to ultimately find immuno-stimulatory/ suppressive biomarkers in order to develop novel diagnostic/ prognostic tools.
NCT04697264 — Obesity
Status: Active, not recruiting
http://inclinicaltrials.com/obesity/NCT04697264/
Phase I Safety Study of Whole Pelvic Hypofractionated Radiotherapy in Women With Endometrial Cancer
This study will investigate if a shorter treatment course (known as "hypofractionation") for pelvic radiation is safe for women with endometrial cancer. Doctors leading the study will also determine the safest and most tolerable dose of shortened radiation (hypofractionation) used to treat women in this study. Because this study will shorten the radiation course typically used to treat endometrial cancer, each daily treatment given to women in this study will be slightly higher than normal to ensure that the total radiation dose they receive is still effective and similar to the radiation dose they would receive if they were not participating in this study (standard treatment).
NCT04683653 — Endometrial Cancer
Status: Recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT04683653/
Prospective Observational Study on Sentinel Node Biopsy Using Two Concurrent Labelling Techniques (Radioactive Tracer With/Without Blue Dye vs. Indocyanine Green-ICG) in Early-stage Endometrial Cancer Patients (TESLA-1).
Sentinel lymph node (SLN) biopsy is currently used in the management of vulvar and breast cancers as well as in malignant melanoma, and is being intensively studied in patients with cervical and endometrial cancers. The role of lymphadenectomy in the surgical management of early-stage endometrial cancer is still controversial. The main reason to perform a SLN biopsy is to detect the lymph node that will be the first involved with metastatic disease in the nodal basin. The SLN biopsy is performed after the SLN is located with the use of different tracers in a concept called SLN mapping. Moreover, SLN evaluation has been reported to improve the accuracy of lymph node staging due to SLN pathologic ultrastaging, which includes multiple serial sectioning and immunohistochemical assessment. The aim of this project is to conduct a multicentre, prospective, observational trial to compare two different SLN labelling methods (radioactive tracer with/without blue dye vs. indocyanine green-ICG) in the same patient and to evaluate the unilateral detection rate, sensitivity, number of detected SLN, anatomical localisation of detected SLN and bilateral detection rate of SLN. The main aim of the trial is the comparison of SLN mapping between two SLN labelling methods in the same patient. The trial will answer a question whether a combination of labelling methods in the same patient increase importantly the sensitivity of SLN biopsy. The trial has a high potential to reach the calculated number of cases and thus bring in evidence/data that will be essential for future management of SLN biopsies in endometrial cancer.
NCT04665544 — Endometrial Cancer
Status: Recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT04665544/
Cell-free DNA Methylation for the Diagnosis and Monitoring of Endometrial Cancer: The Training and Validation Sets in China
Liquid biopsy is challenging for the diagnosis of endometrial cancer. In this study, investigators perform the methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in endometrial cancer. The study compromises two stages. In the training set, DNA methylation testing is performed in the endometrial tissues from patients with endometrial cancer and paired benign uterine lesions. The cut-off values of methylation are produced in this stage. On the meantime, DNA methylation testing is also performed in serum and in cervical cytology to reveal its accordance and accuracy compared with the results of endometrial tissues. In the validation set, serum DNA methylation testing is performed in unselected patients with definite endometrial histology to validate its accuracy. In training and validation sets, serum DNA methylation is also performed after major surgeries for endometrial cancer as to illustrate the changes of methylation testing, therefore, reflection the supervision role of DNA methylation.
NCT04651738 — Endometrial Cancer
Status: Recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT04651738/
A Single-Arm, Single-Center, Open-Label Pilot Study of Anti-ALPP CART-cells in Patient With Alkaline Phosphatase, Placental (ALPP)-Positive Metastatic Ovarian and Endometrial Cancer.
The goal of this clinical trial is to evaluate the safety and efficacy of anti-ALPP chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with ALPP-positive metastatic ovarian and endometrial cancer.
NCT04627740 — Ovarian Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/ovarian-cancer/NCT04627740/
Prediction of Recurrence Among Low Risk Endometrial Cancer Population
This study investigates whether molecular testing can help to predict the risk of endometrial cancer coming back (recurrence) after treatment in patients diagnosed with low risk endometrial cancer and scheduled to have surgery to remove the uterus and/or cervix (hysterectomy). Having sentinel lymph node mapping performed may help researchers to see if the cancer has spread in patients with low risk endometrial cancer.
NCT04604613 — FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
Status: Recruiting
http://inclinicaltrials.com/figo-grade-1-endometrial-endometrioid-adenocarcinoma/NCT04604613/
Relationship of Endometrial Cancer and Serum Soluble L1CAM Level
The aim of this study is to evaluate the effect of serum soluble L1CAM (sL1CAM) on the diagnosis and prognosis of endometrial cancer. This prospective randomized controlled trial will be conducted in patients who have undergone endometrial biopsy and whose pathology results are reported as benign endometrial changes, endometrial hyperplasia, or endometrial cancer. The sL1CAM level between groups will be compared. The relationship between prognostic factors and serum sL1CAM will be evaluated in patients with endometrial cancer.
NCT04603599 — Endometrium Cancer
Status: Completed
http://inclinicaltrials.com/endometrium-cancer/NCT04603599/