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Ovarian Cancer clinical trials

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NCT ID: NCT04214210 Recruiting - Breast Cancer Clinical Trials

The DIALOGUE Study: Swiss-Korean Billateral Collaboration

DIALOGUE
Start date: April 15, 2022
Phase: N/A
Study type: Interventional

In Hereditary Breast and Ovarian Cancer (HBOC) communication of genetic test results with relatives is essential to cascade testing. According to privacy laws those identified with the pathogenic variant have the sole responsibility to share information about test results and implications to relatives. Up to 50% of biological relatives are unaware of relevant genetic information, suggesting that benefits of genetic testing are not communicated effectively. Interventions designed to help mutation carriers communicate with relatives are critical for cascade genetic testing. Technology could play a significant role in facilitating communication and genetic education within HBOC families The investigators will develop a digital health platform for Swiss and Korean HBOC families. The digital platform will be based on the Family Gene Toolkit (FGT), a web-based intervention designed to enhance communication of genetic test results within HBOC families that has been tested for acceptability, usability, and participant satisfaction. The investigators will expand a Swiss research infrastructure to enable future collaborative projects between the two countries. Specific Aims 1. Develop a digital health platform to support the communication of cancer predisposition in HBOC families, based on linguistic and cultural adaptation methods of the FGT for the Swiss and Korean population 2. Develop the K-CASCADE research infrastructure in Korea by expanding the research infrastructure developed by the CASCADE Consortium in Switzerland 3. Evaluate the efficacy of the digital platform on psychological distress and communication of genetic test results, and knowledge of cancer genetics, coping, and decision making 4. Explore the reach, effectiveness, adoption, implementation, and maintenance of the digital platform The digital platform will be based on the FGT with linguistic adaptation for web and mobile access. Aim 1 will be achieved with focus groups with 20-24 HBOC mutation carriers and relatives and 6-10 providers involved in genetic services. For Aim 2, a Korean database of HBOC families (K-CASCADE) will be based on the Swiss CASCADE database. For Aim 3, feasibility and efficacy of the digital solution against the comparison intervention will be assessed in a randomized trial with a sample of 104 HBOC mutation carriers (52 in each arm). Aim 4 will be achieved with survey and interview data collected from HBOC families and healthcare providers during all phases of the study.

NCT ID: NCT04188652 Recruiting - Ovarian Cancer Clinical Trials

Diagnosing Ovarian Cysts - the DOC Study

Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

Background: Ovarian cysts are common in women. The vast majority is benign; yet, ovarian cancer (OC) is seen in 500 women every year in Denmark. OC is often diagnosed in advanced stages, and OC is the fifth most deadly cancer in women in more developed countries. It can be a clinical challenge to distinguish benign ovarian cysts from OC. Currently, the Risk of Malignancy Index (RMI) is used to detect women at high risk of OC in Denmark, however, new methods to correctly differentiate benign ovarian cysts from OC at an early stage is needed. New promising studies suggest an improved diagnostic accuracy by adding the biomarker Human Epididymis Protein 4 (HE4) and systemized ultrasound imaging International Ovarian Tumor Analysis (IOTA). Purpose: The purpose is to evaluate the diagnostic performance of HE4 and IOTA in a Danish clinical setting. Furthermore, to develop an optimized diagnostic algorithm to differentiate ovarian cysts based on a combination of symptoms, biomarkers and IOTA. Methods: The study is a prospective, observational study. Women with ovarian cysts are included from gynecological practitioners and departments in the Capital Region of Denmark. Detailed information on health and symptoms are registered, and the cysts are systematically described by the gynecologist in accordance to the IOTA terminology. HE4 will be analyzed in those women who routinely needs a diagnostic blood test for CA125. Data will be coupled with data from the patient file and Danish Gynecological Cancer Database (DGCD). The diagnostic utility of HE4 and IOTA will be evaluated both alone and in combinations with health information, symptoms, and CA125. The study has been approved by the Regional Committee on Health Research Ethics (H-19021342) and the Data Protection Agency (P-2019-340). Significance: This study establishes a unique database which will form the basis for developing an optimized method for differentiating ovarian cysts, and thus optimize referral and diagnosis.

NCT ID: NCT04180371 Recruiting - Ovarian Cancer Clinical Trials

Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression

Start date: November 7, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical trial is evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors historically known for expression of EphA2. The main goals of this study are to: - Find the recommended dose(s) of BT5528 that can be given safely to participants alone and in combination with nivolumab - Learn more about the side effects of BT5528 - Learn about how effective BT5528 is for the treatment of ovarian cancer, urothelial/bladder cancer, lung cancer (NSCLC), triple-negative breast cancer, head and neck cancer (HNSCC), and gastric/upper gastrointestinal cancer. - Learn more about BT5528 therapy alone and in combination with nivolumab.

NCT ID: NCT04170712 Recruiting - Ovarian Cancer Clinical Trials

Data and Specimen Bank of Patients Diagnosed With, and at High-risk for, Gynecologic Cancers

Start date: June 10, 2016
Phase:
Study type: Observational

The purpose of this project is to establish a bank at UVa of tampon samples, cervical swabs, blood, associated tumor specimens that would otherwise be discarded, and relevant medical data from consenting patients that have suspected and/or confirmed gynecological cancer diagnoses. The specimens collected will be saved for analysis on future projects to determine if factors in the specimens are predictive and/or correlated to gynecological cancer diagnoses and/or outcomes

NCT ID: NCT04169997 Recruiting - Ovarian Cancer Clinical Trials

A Study of IMP4297 as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer

FLAMES
Start date: December 24, 2019
Phase: Phase 3
Study type: Interventional

IMP4297 is a PARP inhibitor. This is a 2:1 randomized, double-blind, placebo-controlled study conducted in patients with advanced (FIGO Stage III or IV) ovarian cancer to evaluate Efficacy and Safety of IMP4297 for Maintenance Treatment

NCT ID: NCT04147494 Recruiting - Breast Carcinoma Clinical Trials

Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues

Start date: November 5, 2019
Phase: Early Phase 1
Study type: Interventional

This phase I trial studies a new imaging technique called FAPi PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulate in normal and cancer tissues in patients with non-prostate cancer. The research team also want to know whether what they see on PET/CT images represents the tumor tissue being excised from the patient's body. The research team is also interested to investigate another new imaging technique called PSMA PET/CT. Participants will be invited to undergo another PET/CT scan, with the PSMA tracer (68Ga-PSMA-11). This is not required but just an option for volunteer patients. Patients who have not received an 18F-FDG PET/CT within one month of enrollment will also undergo an FDG PET/CT scan. The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of, in the case of this research, 68Ga-PSMA-11 and 68Ga-FAPi, and 18F-FDG (if applicable). Because some cancers take up 68Ga-PSMA-11 and/or 68Ga-FAPi it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs where it occurs in patient's body. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers. PSMA stands for Prostate Specific Membrane Antigen. This name is incorrect as PSMA is also found in many other cancers. The function of PSMA is not well understood but imaging studies have shown that PSMA can be detected with PET in many non-prostate cancers. Imaging FAP with PET/CT may in the future provide additional information about various cancers.

NCT ID: NCT04140526 Recruiting - Ovarian Cancer Clinical Trials

Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC

PRESERVE-001
Start date: September 16, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a First-in-Human Phase IA/IB/II open label dose escalation study of intravenous (IV) administration of ONC-392, a humanized anti-CTLA4 IgG1 monoclonal antibody, as single agent and in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell lung cancers.

NCT ID: NCT04122235 Recruiting - Ovarian Cancer Clinical Trials

The Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology Study

LETSGO
Start date: November 18, 2019
Phase: N/A
Study type: Interventional

This study compares traditional follow-up of gynaecological cancer patients to an alternative follow-up model. In the alternative follow-up model the patients will meet a nurse at every second consultation. The nurse will focus on psychosocial health and educate the patients in the use of a study specific smartphone-application.

NCT ID: NCT04104776 Recruiting - Endometrial Cancer Clinical Trials

A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas

Start date: September 18, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

First-in-human, open-label, sequential dose escalation and expansion study of CPI-0209 in patients with advanced solid tumors and lymphomas. CPI-0209 is a small molecule inhibitor of EZH2.

NCT ID: NCT04089189 Recruiting - Ovarian Cancer Clinical Trials

Study of IMP4297 in Patients With BRCA1/2 Mutation Ovarian Cancer

SABRINA
Start date: September 11, 2019
Phase: Phase 2
Study type: Interventional

A phase II, multi-center, open-label, single-arm, non-randomized study to evaluate the efficacy, safety and tolerability of IMP4297 capsules in subjects with germline and/or systemic BRCA1/2 mutated advanced ovarian cancer in china