Diagnostic precision of in vitro diagnostics in predicting a therapeutic outlook in patients with recurrent ovarian cancer (predictor study) - Predictor-Study

TherapySelect GmbH & Co KG0 个研究点目标入组 260 人开始时间: 2012年12月14日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Patients = 18 years with a histologically verified ovarian cancer
•- Patients must have elevated CA 125 levels (> 70 U/ml); a follow-up of these laboratory parameters must be medically indicated
•- In the case of first-time affection:
•o A chemotherapy carboplatin and paclitaxel is indicated
•- In the case of a recurrence:
•o Pre-treatment with platinum-based mono or combination therapy
•o A mono-therapy consisting of topotecan or liposomal doxorubicin (e.g. Caelyx®) is indicated (no progression having previously occurred while using the applied substance)
•- A puncture to extract the existing ascites or preural effusion and/or a surgical intervention for the extraction of tumor tissue must be medically indicated
•- Patients must geographically situated in a manner to be able to participate in treatment
•- Tumor cell count of the extracted ascites/preura punctate or tumor tissue: = 5 x 106 cells
•- ECOG status = 2
•- Written consent for participation in the study after the patient has been well informed about the content and purpose of the evaluation of performance assessment and has understood it

•- Ovarian tumors with low malignant potential (e.g. borderline tumors)
•- Non-epithelial ovarian tumors or mixed tumors (e.g. Mueller'scher mixed tumor)
•- Patients who have received radiation therapy and/or chemotherapy and/or immunotherapy within three weeks prior to puncture
•- Patients who have had another diagnosed malignancy within the past 5 years which could not be resolved through surgery alone (except CIS of the cervix or adequately treated basal cell carcinoma of the skin)
•- The concurrent application of another neoplastic therapy (chemotherapeutics, hormone therapeutics, or immunotherapeutics), or concurrent radiotherapy during the course of treatment of the study (hormone replacement therapy (HRT), steroid antiemetics, for example, are permitted)
•- Dementia or a severe change in mental status impairing the patient's ability to comprehend the study or to consent to participation
•- Pregnant or lactating women

发起方

TherapySelect GmbH & Co KG