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Ovarian Neoplasms clinical trials

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NCT ID: NCT04823871 Completed - Ovarian Cancer Clinical Trials

Early Detection of High Grade Ovarian Cancer Using Uterine Lavage EHUD Study and Duplex Sequencing

EHUD
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

In Phase I the sponsor will systematically test conditions for lavage filtration that increase tumor cell fraction without reducing tumor mutation yield. The Sponsor will also transition all lavages to luteal phase timing, when endometrial shedding is least. In Phase II the Sponsor will examine our data in context of clinical characteristics, particularly age, to develop a multivariate model that determines optimal mutant allele frequency (MAF) diagnostic threshold by patient. Furthermore, the sponsor will explore a highly innovative idea, entailing empirically determining each individual's background mutation load, agnostic of the aging or mutagenic exposures responsible, and using this as a personalized calibrator to determine optimal MAF diagnostic threshold.

NCT ID: NCT04823065 Completed - Ovarian Cancer Clinical Trials

4FMFES-PET Imaging of Endometrial and Ovarian Cancers

Start date: September 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This project is about exploring a novel method to detect ovarian and uterine cancers earlier and better. More precisely, a high-performance radioactive estrogen analog will be used to visualize hormone-sensitive uterine and ovarian tumors using PET imaging. Not only this imaging methodology could improve the whole-body assessment of those diseases, but will also hint clinicians about the optimal course of therapy to undertake. The lead investigator's team designed in the past years an innovative radioactive estrogen derivative tracer (4FMFES) for the medical imaging modality termed Positron Emission Tomography (PET). The compound was first shown to be safe for human use. Recently, a clinical trial demonstrated that 4FMFES-PET is superior to any existing comparable tracer for detection of hormone-sensitive breast cancer patients. 4FMFES is particularly useful to pinpoint unsuspected metastases early, which allowed better breast cancer patient management and staging. 4FMFES and standard FDG PET imaging were shown to be complementary in breast cancer, the use of both techniques together providing a detection rate nearing 100%. Since ovarian and uterine cancers are about as likely to be targeted by 4FMFES as breast cancer, the use of this novel precision imaging method will be adapted to those other indications. In general, the sooner a cancer is diagnosed and treated, the better the outcome of a patient will be. Gynecological cancers lack precise screening and detection tools. In particular, while a majority of uterine cancers are relatively well managed, patients burdened with metastatic burden have a much worse prognosis, and precise and early detection of those lesions will greatly help clinicians to better treat those complicated cases. As for ovarian cancers, they are usually devoid of clinical symptoms until late onset, which partly explain the high mortality rate of this disease. Hence, for both diseases, a precision, whole-body imaging technique will allow earlier assessment, followed by earlier intervention, resulting in improved survival rate and better quality of life for patients.

NCT ID: NCT04817501 Completed - Breast Cancer Clinical Trials

Phenotypic Spectrum of CTCs in Tumors of the Female Reproductive System

CTCs
Start date: February 14, 2014
Phase:
Study type: Observational

The study evaluates the level and molecular profiles of different CTC populations as markers for predicting the risk of developing hematogenous metastases and the effectiveness of treatment in patients with tumors of the female reproductive system (breast cancer, endometrial cancer, and ovarian cancer). The primary objective are: 1. To assess the presence and number of different populations of CTCs at different time points (before biopsy, before surgery, and after surgery). 2. To assess the relationships of different CTCs populations prior to treatment initiation with the effects of neoadjuvant chemotherapy and the risks of recurrence and metastases. 3. To assess the molecular profiles of different CTCs populations in the blood and in ascitic fluid. The secondary objective is to compare the multicolor flow cytometry results with data of ultrasound, CT and/or MRI, serum tumor markers, and immunohistochemical studies in patients with breast cancer, endometrial cancer and ovarian cancer

NCT ID: NCT04817449 Active, not recruiting - Ovarian Cancer Clinical Trials

Spectroscopy in Ovarian Cancer

Start date: June 28, 2021
Phase:
Study type: Observational

Ovarian cancer is the eighth most common cause of cancer death in the world. Advanced stage at diagnosis is associated with lower survival rates, thus early detection appears to have an important role. Raman Spectroscopy is a non-invasive technique that uses the interaction of light to identify the composition of the sample tested. The aim of the project is to explore the use of spectroscopic techniques in the detection of ovarian cancer. There are two different assessments within the project: 1. Identify ovarian cancer in blood - Raman spectroscopic analysis will be performed on blood plasma taken from patients with suspected ovarian cancer. 2. Detect active cancer within post chemotherapy fibrotic tissue - Ex vivo Raman spectroscopic analysis of peritoneal, omental or ovarian tissues collected from patients undergoing surgical treatment for ovarian cancer. The results of the spectroscopy will be correlated to clinical outcome and histological diagnosis respectively.

NCT ID: NCT04815408 Recruiting - Ovarian Cancer Clinical Trials

PD-1 Antibody Combined Neoadjuvant Chemotherapy for Ovarian Cancer

Start date: April 1, 2021
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to validate the efficacy and safety of anti-PD-1 in combination with neoadjuvant chemotherapy in women with advanced ovarian cancer.

NCT ID: NCT04812938 Not yet recruiting - Ovarian Cancer Clinical Trials

Exploiting Pathogenic Tp53 Mutation for Early Diagnosis of Ovarian Cancer by Mean of Papanicolau Test

PAPAudit
Start date: April 12, 2021
Phase:
Study type: Observational

The aim of the project is to corroborate them on a large retrospective cohort of HGS-EOC and confirm the possibility of identify TP53 mutations in high grade endometrioid tumors. This will consequently allow to confirm the previous results and define with a greater precision the temporal windows in which it will be possible to detect, through the TP53 analysis, tumor material by vaginal swab sampling. The results of the study will be the first step of a multiphase prospective validation program for the development of a novel approach for early diagnosis of EOC.

NCT ID: NCT04811703 Recruiting - Clinical trials for Peritoneal Carcinomatosis

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Associated With Systemic Chemotherapy in Women With Advanced Ovarian Cancer

PIPACOVA
Start date: July 30, 2021
Phase: Phase 1
Study type: Interventional

Women with history of tumor response insufficient to allow complete cytoreductive surgery after three cycles of previous neoadjuvant systemic carboplatin-paclitaxel chemotherapy will be prospectively recruited in this trial. After signed consent and if unresectability is confirmed, patients will undergo three cycles of doxorubicin-cisplatin PIPAC chemotherapy associated with systemic carboplatin-paclitaxel chemotherapy (alternating PIPAC and intravenous chemotherapy sessions over 3 cycles of 4 weeks). The primary objective of the study is to determine the maximum tolerated dose (MDT). During cycle 1, limiting dose toxicity must be collected as soon as it is known. Each patients will be treated at the dose recommended by the CRM (Continual Reassessment Method ) algorithm conditional on dose-limiting toxicity during Cycle 1. The dose escalation will be guided by CRM to determine the recommended dose of PIPAC chemotherapy for phase II trial. Secondary objectives are : - to evaluate the anatomopathological response, the radiologic tumoral response and the evolution of the peritoneal cancer extent, to the combined chemotherapy - to describe the pharmacokinetic of the PIPAC chemotherapy - to investigate the KELIM parameter as a predictive marker in the response sensitivity of the combined chemotherapy treatment - and to evaluate the safety of the combined chemotherapy. During the first day of the first cycle, blood samples will be collected to measure doxorubicin and cisplatin (pharmacokinetic study). Along these 3 cycles, the dose of antigen CA-125 will be performed before each chemotherapies (intraperitoneal or intravenous). At the end of combined chemotherapy treatment, patients will undergo radiologic tumoral response by imaging assessment (scanner or MRI) and a last dosage of CA-125 will be realized.. In case of a complete / partial response / stabilization (RECIST criteria v.1.) on the imaging, re-evaluation for resectability will be done. If resectable disease, cytoreductive surgery will be programmed and a post-operative visit 1 month later will be realized. Otherwise for patients with progress disease or unresectable the participation in the study will be finished.

NCT ID: NCT04807166 Not yet recruiting - Ovarian Neoplasms Clinical Trials

Anlotinib Combined With Carboplatin/Paclitaxel as First-line Treatment in Patients With Advanced Ovarian Cancer

Start date: June 1, 2021
Phase: Phase 2
Study type: Interventional

It has been reported that antiangiogenic drugs combined with chemotherapy as first-line treatment, and subsequent antiangiogenic drugs as maintenance therapy for ovarian cancer can achieve better clinical benefits. Therefore, this study is expected to investigate the efficacy and safety of anlotinib combined with carboplatin/paclitaxel as first-line treatment in patients with advanced ovarian cancer.

NCT ID: NCT04805333 Recruiting - Ovarian Cancer Clinical Trials

Phase 1 Dose Escalation of ArtemiCoffee

Start date: March 26, 2021
Phase: Phase 1
Study type: Interventional

This is a phase I dose-escalation study of Artemisia annua (Aa) in patients with advanced ovarian cancer who have completed front-line chemotherapy with carboplatin and paclitaxel. The primary objective of this study is to determine the recommended phase II dose (RP2D) of Artemisia annua.

NCT ID: NCT04795596 Withdrawn - Ovarian Cancer Clinical Trials

Secondary Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancers

Start date: April 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This novel study was specifically designed for platinum resistant recurrent ovarian cancers and aimed to compare cases who received secondary cytoreductive surgery for isolated recurrence and chemotherapy versus chemotherapy alone. This comparison will conduct the intraoperative events, postoperative morbidity and mortality, pathological outcomes and long-term oncological outcomes as regarding progression free survival and overall survival rates.