Clinical trial · Interventional
Early Detection of High Grade Ovarian Cancer Using Uterine Lavage EHUD Study and Duplex Sequencing
Pilot Study of Early Detection of High Grade Ovarian Cancer Using Uterine Lavage and Duplex Sequencing
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 to luteal phase timing, when endometrial shedding is least. In Phase II the Sponsor will examine our data in context of clinical characteristics, particularly age, to develop a multivariate model that determines optimal mutant allele frequency (MAF) diagnostic threshold by patient. Furthermore, the sponsor will explore a highly innovative idea, entailing empirically determining each individual's background mutation load, agnostic of the aging or mutagenic exposures responsible, and using this as a personalized calibrator to determine optimal MAF diagnostic threshold.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma in Situ | Carcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Epithelial Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Speiser-catheter for uterine and tubal lavage | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- High risk patients for breast and/or ovarian cancer
- description
- Procedure/Surgery: Lavage of the Cavum uteri and proximal Fallopian tubes, performed in the luteal phase of the female cycle
- interventionNames
- Procedure: Speiser-catheter for uterine and tubal lavage
- type
- OTHER
- label
- Suspected Ovarian Epithelial Cancer
- description
- Procedure/Surgery: Lavage of the Cavum uteri and proximal Fallopian tubes, performed in the luteal phase of the female cycle
- interventionNames
- Procedure: Speiser-catheter for uterine and tubal lavage
Primary outcomes (7)
- measure
- Variant allele frequencies (VAF) for variants identified in both unfiltered and filtrate uterine lavage from the same patient.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * Incapacitated women * Pregnant women * Prior hysterectomy * Prior bilateral salpingectomy * Prior tubal ligation * First half of menstrual cycle * Interval debulking * Current cytotoxic chemotherapy
References
Publications (0)
Data not yet available