The Assessment of Mesothelin Antigen Specific Immunologic Assays in Ovarian Cancer Patients
Ovarian CancerOvarian cancer is the first in mortality rate of the gynecologic malignancies and the overall 5-year survival rate of ovarian cancer is only 20-30%. Besides, the incidence of ovarian cancer increased in recent years in Taiwan. Ovarian cancer is indeed a disease that should be respected, however, there has only been a little research done focusing on it in Taiwan. Patients with ovarian cancer who have stage I disease (localized to ovaries) after optimal surgical staging do not need any adjuvant therapy. In contrast, patients with disease spreading beyond the ovaries have median survival rates that decrease to < 10% for patients with bulky residual disease after surgery and treated with platinum-based combination chemotherapy. In developing effective therapy for ovarian cancer, there should be a distinction between preventative and therapeutic approaches. Immunoprevention will be developed for women who are at an increased risk for the development of ovarian cancer. In contrast, immunotherapy would be used as an adjuvant to surgery or in combination with chemotherapy or other biologics as chemoimmunotherapy or biochemoimmunotherapy. Mesothelin is expressed in some normal epithelial cells and is elevated in certain carcinomas. Mesothelin has been reported to be selectively overexpressed in most of the non-mucinous ovarian carcinomas. In addition, the specific epitopes of mesothelin in the HLA-A2 and A24 haplotype have been identified. It seems that mesothelin has the potential to be a target antigen for the immunotherapy of ovarian cancer. So the investigators would like to provide this proposal to address the development of mesothelin -specific immunologic assays. There are two aims in this project: to develop and utilize assays to measure cytotoxic T lymphocytes (CTLs) to mesothelin, and to evaluate the mesothelin-specific immunologic responses between normal control and ovarian cancer patients.
Cytoreduction With or Without Intraoperative Intraperitoneal Hyperthermic Chemotherapy (HIPEC) in...
Peritoneal Carcinomatosis From Ovarian CancerFallopian Tube Carcinoma1 moreThe purpose of this clinical trial is to Investigate whether the administration of HIPEC with Cisplatin (75 milligrams per square meter of body surface) after surgical cytoreduction in women with ovarian, tubal or primary peritoneal carcinoma increased disease-free survival period compared with patients without HIPEC treatment.
A Study of Docetaxel and Lobaplatin Versus Docetaxel and Carboplatin Combination Regimen in Patients...
Recurrent Ovarian CancerThe purpose of this study is to evaluate the effectiveness and security of lobaplatin combined with docetaxel in treatment of the sensitive recurrent ovarian cancer.
The Role of HE4 in the Follow-up of Advanced Ovarian, Fallopian Tube and Primary Peritoneal Cancer...
Ovarian NeoplasmsTo evaluate and to compare the effectiveness of CA-125 and HE4 serum levels in epithelial ovarian cancer (OC) in follow-up in terms of time to detection of elevation after the end of the first line treatment. To evaluate the lead-time of the rise of marker levels before epithelial OC recurrence diagnosis by Computed tomography (CT) imaging method. To evaluate the appropriate HE4 cut-off value for follow-up of patients after the treatment of ovarian, Fallopian tube and primary peritoneal cancer.
An Observational Study of Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine...
Ovarian CancerThis is a Non-interventional, Multicenter study evaluating the efficacy and safety of the combination of pegylated liposomal doxorubicin and trabectedin in routine practice in patients with recurrent partial-platinum sensitive ovarian cancer, which is held in Kazakhstan.
Intra-peritoneal Chemotherapy in Ovarian Cancer
Ovarian NeoplasmsImmune Tolerance2 moreOvarian cancer is the third most common gynecological malignancy worldwide. Because of late, aspecific symptoms, the disease is usually diagnosed at an advanced stage. Most patients experience recurrence and die as a result of the disease within 5 years. Treatment is a combination of surgical debulking and systemic administered chemotherapy. Intra-peritoneal (IP) chemotherapy with is currently considered the most effective treatment. In patients with at least an optimal surgical debulking, this leads to an improvement in life expectancy from 50 to 66 months. IP administration of chemotherapeutic agents is still not common practice. Furthermore recent studies revealed that cancer cells express a variety of tumor antigens, which can be targeted by the immune system. Also ovarian cancer shows evidence of a role for the immune system in clinical outcome. Novel insights into the mechanism of action of chemotherapy indicate that the efficacy of chemotherapeutic interventions are dependent on the modulation of the immune system. The impression exists that since IP chemotherapy is used, relatively more recurrences outside the abdominal cavity are observed. As of yet, no studies have described pharmacokinetics and pharmacodynamics of IP administered cisplatin and paclitaxel in the blood circulation. The investigators propose to study the use of this aspiration fluid from the IP cavity as a biomarker for the efficacy of chemotherapy intervention, monitor the effect of chemotherapy on IP tumor cells in the peritoneal cavity and monitor the effect of chemotherapy on immune cells present in the IP cavity. As well the investigators propose to correlate the presence and amount of tumor cells in peritoneal fluid with the debulking efficacy and CA 125 levels. Secondary to this the investigators intend to determine the pharmacokinetics of cisplatin and paclitaxel when administered in the IP cavity in the central circulation (plasma) as well as in the peritoneal fluid. In this observational explorative study women, aged younger than 70 years, who will receive standard IP chemotherapy for advanced epithelial ovarian cancer, who are in an adequate physical and biochemical state to receive chemotherapy are included. Immunological cell counts, tumor marker, immunological cell pathway activation and plasma concentrations of cisplatinum and paclitaxel in venous blood and in fluid aspirated from the abdominal cavity will be measured.
Primary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Using Caiman®...
Ovarian CancerLongitudinal prospective study on primary debulking surgery including bowel resection in advanced stage ovarian cancer patients using Caiman® technology
Blood Test for Ovarian Cancer Associated Auto Antibodies
Ovarian CancerIntend of use: A blood test for Cancer Associated Antibodies (CAAA) is an aid in initial diagnosis of ovarian cancer in women with suspected ovarian pathology as detected by primary diagnostic techniques. Test Description: Blood is collected from patients and serum/plasma is tested for the presence of CAAA on experimental test kit. Objectives: To assess the effectiveness of the CAAA test. Target Population: The study population will include women that have been diagnosed with suspected ovarian cancer (OC), verified by pathology/cytology as patients, women with suspected ovarian cancer but verified by pathology/cytology as non-cancers and a control set of blood samples will be collected from age matched women with no history of cancer. Structure: Women that will be enrolled for the study will be checked for the presence of CAAAb, and the results of the CAAAb test will be compared to the pathology submitted by the physicians in the participating centers for the patient population and to the clinical history for the control population. Sample Size: The investigators will collect at least 50 patients verified by pathology/cytology and for each patient at least two aged matched healthy controls and two aged matched suspected but verified as non-cancers. Total amount at least 250 samples. (Multi center study, statistical rationale provided below). Primary Effectiveness Variables: The effectiveness of the test will be defined by the specificity of the test conditionally that the sensitivity is not lower than a pre-defined level of 95%. Endpoint: The endpoint of this study is to show that the effectiveness is higher than 50%. Clinical Monitor: For each site a dedicated CRO will be appointed to monitor the clinical trials. All data will be stored in a protected internet-based database, and any changes of the data will be traced and recorded.
Quality of Life Associated With a Low-Risk Screening Program for Ovarian Cancer
Ovarian CancerThe goal of this research study is to learn more about how women feel about an ovarian cancer screening program that involves getting a blood test to measure CA 125 levels. This includes finding out about women's quality of life and whether they are concerned or worried about their risk of developing cancer. This study also seeks to find out whether elevated CA 125 levels affect participants in terms of cancer worries or concerns.
Niraparib as Maintenance Treatment in Platinum Responsive Ovarian Cancer Patients: a Real Life Study...
Ovarian CancerThis is an observational phase IV study evaluating Niraparib as maintenance treatment in patients with platinum sensitive, platinum responsive, recurrent ovarian cancer in a real life setting.