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Clinical Trials/DRKS00001856
DRKS00001856
Recruiting
Not Applicable

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 sites260 target enrollmentDecember 14, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
C56
Sponsor
TherapySelect GmbH & Co KG
Enrollment
260
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 14, 2012
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
TherapySelect GmbH & Co KG

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • \- 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

Outcomes

Primary Outcomes

Not specified

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