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Ovarian Neoplasm Epithelial clinical trials

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NCT ID: NCT06103214 Completed - Clinical trials for Ovarian Neoplasm Epithelial

The Effects of Hemodilution Methods in Patients Undergoing Primary Debulking Gynaecological Surgery

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

Primary cytoreductive surgery for ovarian cancer is an ideal setting to evaluate endothelial function under ANH and AHH, as the procedure is associated with moderately high blood loss. As the technique has not yet been described in this setting, investigators designed a pilot study to evaluate ANH and AHH in patients planned to undergo primary cytoreduction during perioperative period, with the intent of proceeding to a randomized trial if results were favorable.

NCT ID: NCT05960630 Recruiting - Ovarian Cancer Clinical Trials

MIRRORS-RCT Pilot: Role of Robotic Interval Cytoreductive Surgery for Advanced Ovarian Cancer

MIRRORS-RCTP
Start date: October 2, 2023
Phase: N/A
Study type: Interventional

The survival of ovarian cancer patients is dependent on the stage at diagnosis; more than 70% of patients present with advanced stage disease (stage III/IV). In England, one-year survival is 98.7% at stage I and 51.4% at stage IV and five-year survival is 93.3% and 13.4% respectively. Standard treatment for advanced ovarian cancer involves surgery to remove all visible tumour and chemotherapy. Removal of all visible disease, so no tumour deposits are visible to the naked eye at the end of first-line surgery, is one of the strongest predictors of overall survival. A majority of the women presenting with advanced disease are older and frail. Extensive open surgery discriminates against such women as they may not be well enough for the surgery offered. A recent national audit in England found that 60.1% of women over the age of 79yrs diagnosed with ovarian cancer received no cancer treatment at all. The ability to provide the same surgery via a minimally invasive route such as robotic surgery potentially widens access to cancer treatment. The MIRRORS Feasibility study (NCT04402333) completed recently at the Royal Surrey County Hospital in Guildford showed significantly enhanced recovery with short length of stay and reduced blood loss enabling faster recommencement of chemotherapy in women with advanced disease undergoing robotic surgery compared to open surgery (requiring a cut in the abdomen). In the current proposed study funded by Intuitive Foundation and GRACE Charity, the investigators will establish the feasibility of conducting a randomised controlled trial and collect data from three hospital sites to inform a future phase 3 randomised controlled trial. The aim will be to to improve patient experience, access to surgery, recovery, reduce morbidity and reduce time to chemotherapy by incorporating robotic cytoreductive surgery into the ovarian cancer treatment pathway for women with a pelvic mass </=8cm

NCT ID: NCT05605535 Recruiting - Ovarian Cancer Clinical Trials

Oregovomab Plus Chemotherapy in Neo-adjuvant Setting in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer

Start date: February 7, 2023
Phase: Phase 2
Study type: Interventional

A clinical study to compare the efficacy and safety of five administrations of oregovomab versus placebo, infused in schedule dependent sequence with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin), for the treatment of patients with newly diagnosed advanced ovarian cancer who are planned to receive neoadjuvant treatment followed by interval debulking surgery (IDS) and adjuvant treatment.

NCT ID: NCT05001282 Recruiting - Ovarian Cancer Clinical Trials

A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα)

Start date: September 13, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study, ELU- FRα-1, is focused on adult subjects who have advanced, recurrent or refractory folate receptor alpha (FRα) overexpressing tumors considered to be topoisomerase 1 inhibitor-sensitive based on scientific literature, and, in the opinion of the Investigator, have no other meaningful life-prolonging therapy options available. ELU001 is a new chemical entity described as a C'Dot drug conjugate (CDC), consisting of payloads (exatecans) and targeting moieties (folic acid analogs) covalently bound by linkers to the C'Dot particle carrier. ELU001 will be the first drug-conjugate of its kind to be introduced into the clinic, a first in class, and a novel molecular entity.

NCT ID: NCT04780945 Recruiting - BRCA1 Mutation Clinical Trials

Functional Analysis of BRCAness

FAB
Start date: January 21, 2019
Phase: Phase 2
Study type: Interventional

PARP inhibitors are most effective in homologous recombinant (HR) deficient tumors. There are clear indications that besides BRCA1 or BRCA2 mutated EOC, there is an additional group of EOC having deficiencies in HR (i.e. BRCAness) that might benefit from treatment with PARP inhibitors. Assessment of HR in high grade EOC might therefore serve as a better predictive biomarker and allow the identification of a larger group of patients that could benefit most from platinum based chemotherapy and maintenance treatment with a PARP inhibitor. We recently developed a robust ex vivo functional assay (RAD51 assay;) to test HR in viable tumor tissue. In the proposed study, we will evaluate whether the RAD51 assay predicts sensitivity to therapy with olaparib, in patients with recurrent EOC. With the RAD51 assay we aim to identify a larger number of patients who will benefit from treatment with the PARP inhibitor olaparib than patients with a germline or somatic BRCA mutation only. Furthermore, we aim to identify molecular markers (including genomic markers) that are associated with the outcome of the RAD51 assay. Finally, we will explore whether these molecular markers can be measured in liquid biopsies by analysing ctDNA.

NCT ID: NCT04402333 Recruiting - Ovarian Cancer Clinical Trials

Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival

MIRRORS
Start date: June 26, 2020
Phase:
Study type: Observational

MIRRORS "Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival" is a new United Kingdom based prospective feasibility study the purpose of which is to establish the feasibility of launching a British multicentre randomised control trial of Robotic interval debulking surgery for ovarian cancer (including cancer of the fallopian tube & peritoneum) in the future. This initial feasibility study will focus on the ability to recruit patients, acceptability, quality of life, the rate at which it is possible to remove all visible tumour and the rate of conversion to open surgery. Ultimately the investigators would like to determine whether, in selected patients, robotic surgery offers improved quality of life and recovery with equivalent overall and progression free survival. Robotic surgery is unlikely to be suitable in all cases of ovarian cancer, particularly those with large pelvic masses or extensive disease around the upper part of the abdomen, however, it has the potential to provide significant recovery and quality of life benefits to a selected group of patients. MIRRORS - ICG "Peritoneal angiography / perfusion assessment using Indocyanine green (ICG) in patients with advanced ovarian cancers" is a ancillary study within MIRRORS. Using ICG dye, the investigators aim to observe whether there are any changes in the blood vessel pattern associated with the tumour deposits the investigators remove that makes them distinctive. The ICG will not be used to guide where biopsies are taken or tissue is removed. Participation in this ancillary research is not required for participation in the trial.

NCT ID: NCT04111978 Recruiting - Clinical trials for Peritoneal Neoplasms

MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)

MATAO
Start date: November 5, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of addition of letrozole to the standard maintenance therapy in subjects following a primary diagnosis of Estrogen-receptor (ER) positive high and low grade epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) and subsequent primary treatment surgery and chemotherapy. Half of the participants will receive to the standard maintenance treatment, letrozole, whilst the other half receives placebo. The study's primary hypothesis is that the treatment with letrozole increases progression free survival in comparison to the maintenance standard treatment (superiority trial).

NCT ID: NCT03883542 Recruiting - Clinical trials for Ovarian Neoplasm Epithelial

Sub-type Specific Genomic Mutations in sBOTs

Start date: January 2017
Phase:
Study type: Observational

The aim of this study is to identify different origin in carcinogenesis between serous borderline ovarian tumors presenting a. without implants, b. with non-invasive implants, c. with invasive implants and d. with micropapillary pattern. The presence of specific mutations could suggest for a more aggressive primary treatment if a higher risk of recurrence can be expected.

NCT ID: NCT03509246 Recruiting - Clinical trials for High Grade Serous Carcinoma

Bortezomib and Pegylated Liposomal Doxorubicin in BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer Patients

Start date: May 15, 2018
Phase: Phase 2
Study type: Interventional

This study is a phase II clinical trial to evaluate the safety and efficacy of Bortezomib plus Pegylated liposomal doxorubicin combination therapy in a histologic type of high-grade serous carcinoma without BRCA mutation among patients with platinum-resistant recurrent ovarian cancer.

NCT ID: NCT03015376 Recruiting - Clinical trials for Hereditary Breast and Ovarian Cancer Syndrome

Inherited Susceptible Genes Among Epithelial Ovarian Cancer

Start date: January 2017
Phase:
Study type: Observational

Purpose: To investigate the prevalence of the germline mutations in the BRCA 1/2 and mismatch repair genes in patients with epithelial ovarian cancer (EOC) and their relatives, and related somatic mutations in tumor tissues in the northern part of china. Patients and methods: A multicenter prospective study will be hold in the northern part of china form 2017. About 1000 female patients with epithelial ovarian cancer and their ralatives will be tested for germline mutations in the BRCA 1/2 and mismatch repair genes and related somatic mutations in tumor tissues, regardless of the family history. Study type: Observational Official title: Prevalence study of germline mutations in susceptibility ovarian cancer genes in patients with epithelial ovarian cancer and somatic mutations in their tumor tissures in the northern part of china. Enrollment: 1000