View clinical trials related to Ovarian Neoplasms.
Filter by:The ability of different methods to discriminate between benign and malignant adnexal masses has been compared in a meta-analysis showing that the IOTA Simple Rules and the IOTA logistic regression model LR2 were superior to RMI and to all other methods for predicting malignancy in an adnexal mass included in the meta-analysis. However, a fair comparison of methods requires them to be applied on the same tumor population. The general objective of this study is to prospectively validate the Simple Rules, ADNEX, the Simple Rules risk model, LR2, and RMI on a large multicenter dataset to allow direct comparison of these tools. IOTA7 is an international multicenter prospective observational study including different types of ultrasound centers and examiners with different levels of ultrasound experience. In total, about 1700 adnexal masses with histological outcome will be included in IOTA 7.
Gynecological ultrasound is well known as the preferred exam to assess patients with ovarian tumors. The International Ovarian Tumor Analysis (IOTA) group developed the 'Simple Rules' to classify an ovarian tumor as benign or malignant. In about 1/5 of patients the Simple Rules give an inconclusive result and therefore a suitable second line test is necessary. Recently the ADNEXMR SCORING system was developed, this is the first Magnetic Resonance Imaging (MRI) score system that focuses on ovarian tumors. The aim of this prospective study is to evaluate the performance of pelvic MRI examination with perfusion -and diffusion- weighted sequences and the application of the ADNEXMR SCORING system in ovarian tumors that cannot be classified by the IOTA Simple Rules (regarding the prediction of malignancy). Other aims are the determination of the malignancy rate per ADNEXMR SCORING system class, the evaluation of interobserver reproducibility and the assessment of the accuracy of the specific diagnosis based on MRI images. The study is a multicenter prospective study. In centers where perfusion -and diffusion weighted MRI imaging is not a part of clinical routine in unclassifiable ovarian masses based on ultrasound, the study is considered to be interventional. However, in other centres, depending on the local guidelines, perfusion -and diffusion weighted MRI imaging can be standard of care. In these centres, the study can be considered to be observational. The IOTA-MRI project is linked to the IOTA study. In this multicenter study different diagnostic ultrasound algorithms are tested prospectively in patients with an ovarian mass prior to surgery. This study allows to define a subgroup of patients in which Simple Rules are inconclusive, in other words the population eligible for inclusion in the IOTA-MRI project. We plan to include 250 patients in the IOTA-MRI study. Patients will be included consecutively, yet only after completing the informed consent. Recruitment will take 2 years of time as of the start of the individual center. The gold standard is the histopathology diagnosis of the mass within 120 days after ultrasound evaluation. The surgical approach is chosen by the managing clinician.
The aim of this study is to collect data on Korean patients with borderline ovarian tumors.
By obtaining clinical specimens from participants with triple negative breast cancer (TNBC), colorectal cancer (CRC), high grade serous ovarian cancer (HGSOC), and other select tumor types to establish and profile as freshly implanted tumors in mice, the aim of this study is to identify agents with predicted activity in the host patient while also potentially providing them with personalized cancer treatment options
To 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.
Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in ovarian cancer.
This is a phase I prospective study with the primary objective to compare the efficacy and safety of Surgical cytoreduction (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in treatment of recurrent ovarian, primary peritoneal or fallopian tube cancers. Eligible patients consenting to this protocol will undergo their scheduled surgical procedure. After surgical cytoreduction to a residual disease ≤ 2.5 mm, a single dose of carboplatin (800 mg/m2) will be administered in normal saline via intraperitoneal hyperthermic perfusion using the closed-abdomen. HIPEC will be continued for 90 minutes in the hyperthermic phase (41°C-43°C). At 4-6 weeks after CRS, patients will go on to receive 6 cycles of standard IV platinum-based chemotherapy. The proportion of patients who are without evidence of recurrence will be assessed at 6, 9, 12 and 18 months after the day of surgery.
The purpose of this study is to evaluate the safety and one year disease-free survival of total or subtotal colectomy and proctocolectomy in stage IIIc and stage IV epithelial ovarian, fallopian tube, and primary peritoneal cancer (EOC, FTC, PPC).
RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with Relapsed and/or Chemotherapy Refractory Advanced Malignancies.
Background: Epithelial Ovarian Cancer is the most lethal amongst the gynecologic malignancies and is the fifth leading cause of cancer death in women in the United States.1 Despite initial high response rates, 50% to 75% of women who present with advanced disease suffer relapse and require re treatment2.The optimal treatment for platinum resistant ovarian cancer remains hotly debated. Combination chemotherapy is not favored due to its increased toxicity and lack of convincing benefit when compared to single agent chemotherapy.3,4 Recently, the addition of bevacizumab to single agent chemotherapy in the AURELIA study improved progression free survival (PFS) from 3.4 months to 6.7 months. Response rates were also improved from 11.8% versus 27.3% (p= 0 .001).9 Aim: To determine the maximal tolerated dose (MTD) of weekly paclitaxel in combination with LDWART. The recommended phase II dose (RP2D) will be based on the MTD in this Phase I study. Method: This study is designed as a prospective, single arm phase I study with 3+3 with dose de-escalation and cohort expansion. All patients will receive weekly paclitaxel at a pre specified dose of 80 mg/m2, 70 mg/m2, 60mg/m2 or 50 mg/m2 via intravenous infusion according to institution specific standard practices. Cycles of chemotherapy will be administered weekly without interruption on Days 1,8,15,22,29,36 for a total of 6 weekly cycles in combination with LDWART(Fig.1). LDWART will be given at 60 cGy fractions, twice daily for two days, with a minimum of 4 hours inter fraction interval, starting on day 1 of each cycle of weekly paclitaxel for 6 weeks.(Fig.1). Importance of proposed research: The combination of a LDWART with weekly paclitaxel may improve the efficacy of the current standard weekly paclitaxel in platinum resistant ovarian cancer patients. Potential benefits and risks: The combination may improve treatment response. Adding LDWART may increase treatment risks, but these will be monitored closely.