Status:
COMPLETED
Early Detection of High Grade Ovarian Cancer Using Uterine Lavage EHUD Study and Duplex Sequencing
Lead Sponsor:
Paul Speiser, Prof.MD,
Conditions:
Ovarian Epithelial Cancer
Carcinoma in Situ
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief Summary
In Phase I the sponsor will systematically test conditions for lavage filtration that increase tumor cell fraction without reducing tumor mutation yield. The Sponsor will also transition all lavages t...
Detailed Description
APPROACH PHASE I The University of Washington has demonstrated diagnostic proof of principle; however, further optimization and validation is needed for industrial scale deployment. In Phase I the UtL...
Eligibility Criteria
Inclusion
- Written informed consent obtained
- Age ≥ 18 years and ≤ 80 years
- Women undergoing primary surgery for suspected High grade serous carcinoma (HGSC) If premenopausal in luteal phase (minimum 14 days after last day of menstrual period) or:
- Women with high risk for breast or ovarian cancer (HBOC) undergoing prophylactic resection of tubes with or without ovaries. If premenopausal in luteal phase except amenorrhea under hormonal contraception (incl. levonorgestrel -IUD)
Exclusion
- Incapacitated women
- Pregnant women
- Prior hysterectomy
- Prior bilateral salpingectomy
- Prior tubal ligation
- First half of menstrual cycle
- Interval debulking
- Current cytotoxic chemotherapy
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT04823871
Start Date
November 1 2018
End Date
June 30 2022
Last Update
September 2 2022
Active Locations (9)
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1
Medizinische Universität Graz
Graz, Austria
2
Medical University Innsbruck
Innsbruck, Austria
3
Kepler Universitätsklinikum Linz
Linz, Austria
4
Medical University Vienna, Dptm. of Obstetrics & Gynaecology
Vienna, Austria, 1090