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Lavage of the Uterine Cavity for the Diagnosis of Ovarian and Tubal Carcinoma - Study of Sensitivity and Specificity (LUDOC II)

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ClinicalTrials.gov Identifier: NCT02518256
Recruitment Status : Recruiting
First Posted : August 7, 2015
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Paul Speiser, Prof.MD,, Medical University of Vienna

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.


Condition or disease Intervention/treatment Phase
Ovarian Epithelial Cancer Procedure: Lavage of the Cavum uteri and proximal fallopian tubes Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Lavage of the Uterine Cavity for the Diagnosis of Ovarian and Tubal Carcinoma - Study of Sensitivity and Specificity
Study Start Date : May 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
(Suspected) Ovarian Epithelial Cancer
Lavage of the Cavum uteri and proximal fallopian tubes
Procedure: Lavage of the Cavum uteri and proximal fallopian tubes



Primary Outcome Measures :
  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. [ Time Frame: Day 1 ]

    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.




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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • suspected ovarian cancer
  • verified ovarian cancer

Exclusion Criteria:

  • pregnant
  • incapacitated persons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518256


Contacts
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Contact: Paul Speiser, Prof.,Dr.,MD +436765367608 paul.speiser@meduniwien.ac.at
Contact: Claudia Duwe +436765536415 c.duwe@ovartec.at

Locations
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Austria
Medical University Vienna, Dptm. of Obstetrics & Gynaecology Recruiting
Vienna, Austria, 1090
Contact: Paul Speiser, Prof., Dr., MD    +436765367608    paul.speiser@meduniwien.ac.at   
Contact: Nina M Pecha, Dr., MD    +436767168264    nina.pecha@meduniwien.ac.at   
Principal Investigator: Paul Speiser, Prof., Dr., MD         
Sub-Investigator: Elisabeth Maritschnegg, MSc.         
Belgium
Catholic University Leuven Recruiting
Leuven, Belgium, 3000
Contact: Ignace Vergote, Prof. Dr.         
Contact: Siel Olbrecht         
Czechia
Charles University Pilsen Recruiting
Pilsen, Czechia, 30605
Contact: Jiri Bouda, Dr. PhD         
Germany
Klinikum Essen Mitte Recruiting
Essen, Germany, 45147
Contact: Andreas du Bois, Prof. Dr. Dr.         
Contact: Nina Pauly         
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Paul Speiser, Prof.,Dr.,MD Paul SpeiserMedical University Vienna, Dptm. of Obstetrics & Gynaecology
Study Chair: Robert Zeillinger, Prof.,Dr. Medical University Vienna, Dptm. of Obstetrics & Gynaecology, Molecular Oncology Group

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Responsible Party: Paul Speiser, Prof.MD,, Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02518256     History of Changes
Other Study ID Numbers: EK 1151/2014
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Keywords provided by Paul Speiser, Prof.MD,, Medical University of Vienna:
Neoplasms
Glandular and Epithelial
Ovarian Neoplasms
Ovarian cancer
Additional relevant MeSH terms:
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Carcinoma, Ovarian Epithelial
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders