NCT02518256

Brief Summary

The ovarian surface, the Fallopian tubes, the uterine cavity and the peritoneal cavity all together form a communicating compartment. The physiologic function of the ciliated lining of the tubes is to transport the egg, after ovulation, into the uterine cavity. Thus, making it very likely that exfoliated cells from pathologic changes of the ovarian surface and Fallopian tube lining will be present in a lavage from the uterine cavity. The proof of concept that malignant cells from the upper genital tract get transported even into the lower genital tract was recently published by Kind I. et al. Liquid-based cervical cytology allows not only cytological evaluation but also collection of DNA. A panel of genes that are commonly mutated in endometrial and ovarian cancers was assembled with new whole-exome sequencing data from 22 endometrial cancers and previously published data on other tumour types, including mutations in the TP53 gene. This panel was used to search for mutations in 24 endometrial and 22 ovarian cancers and identified mutations in all 46 samples. With a sensitive massively parallel sequencing method, it was possible to identify the same mutations in the DNA from liquid Pap smear specimens in 100% of endometrial cancers (24 of 24) and in 41% of ovarian cancers (9 of 22). In the current project the investigators will study the specificity and sensitivity of the lavage of uterine cavity and proximal tubes as a test to differentiate between malign and benign ovarian tumours. The investigators aim to detect cells from EOCs or genetic material from those cells in the lavage.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 6, 2022

Status Verified

September 1, 2022

Enrollment Period

7.7 years

First QC Date

June 30, 2015

Last Update Submit

September 1, 2022

Conditions

Ovarian Epithelial Cancer

Keywords

NeoplasmsGlandular and EpithelialOvarian NeoplasmsOvarian cancer

Outcome Measures

Primary Outcomes (1)

  • Detection of somatic mutation analysis in at least one of the analyzed genes in cells found in the lavage of the uterine cavity and proximal tubes.

    In the current project the investigators will study the specificity and sensitivity of the lavage of uterine cavity and proximal tubes as a test to differentiate between malign and benign ovarian tumours. The investigators aim to detect cells from EOCs by somatic mutation analysis of the genetic material from those cells in the lavage. To detect cells from EOCs, analysis of lavage fluid will be carried out applying the sensitive massively parallel sequencing method published by Kinde et al. Mutations in the following genes will be analysed: AKT1, APC, ARID1A, BRAF, CTNNB1, CSMD3, CDKN2A, EGFR, FBXW7, FAT3, FGFR2, KRAS, MLL2, NRAS, PTEN, PIK3CA, PIK3R1, PPP2R1A, PIK3R, RNF43, and TP53.

    Day 1

Study Arms (1)

(Suspected) Ovarian Epithelial Cancer

OTHER

Lavage of the Cavum uteri and proximal fallopian tubes

Procedure: Lavage of the Cavum uteri and proximal fallopian tubes

Interventions

Lavage of the Cavum uteri and proximal fallopian tubesPROCEDURE
(Suspected) Ovarian Epithelial Cancer

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • suspected ovarian cancer
  • verified ovarian cancer

You may not qualify if:

  • pregnant
  • incapacitated persons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Medical University Vienna, Dptm. of Obstetrics & Gynaecology

Vienna, 1090, Austria

Location

Catholic University Leuven

Leuven, 3000, Belgium

Location

Charles University Pilsen

Pilsen, 30605, Czechia

Location

Klinikum Essen Mitte

Essen, 45147, Germany

Location

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialNeoplasmsOvarian Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Paul Speiser, Prof.,Dr.,MD

    Paul SpeiserMedical University Vienna, Dptm. of Obstetrics & Gynaecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 30, 2015

First Posted

August 7, 2015

Study Start

May 1, 2014

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

September 6, 2022

Record last verified: 2022-09

Locations

CZ(1)DE(1)AU(1)BE(1)