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 : Unknown
Verified February 2020 by Paul Speiser, Prof.MD,, Medical University of Vienna.
Recruitment status was: Recruiting
First Posted : August 7, 2015
Last Update Posted : February 5, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||540 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 2020|
|Estimated Study Completion Date :||September 2020|
(Suspected) Ovarian Epithelial Cancer
Lavage of the Cavum uteri and proximal fallopian tubes
Procedure: Lavage of the Cavum uteri and proximal fallopian tubes
- 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.
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
|Contact: Paul Speiser, Prof.,Dr.,MDfirstname.lastname@example.org|
|Contact: Claudia Duweemail@example.com|
|Medical University Vienna, Dptm. of Obstetrics & Gynaecology||Recruiting|
|Vienna, Austria, 1090|
|Contact: Paul Speiser, Prof., Dr., MD +436765367608 firstname.lastname@example.org|
|Contact: Claudia M Duwe email@example.com|
|Principal Investigator: Paul Speiser, Prof., Dr., MD|
|Catholic University Leuven||Active, not recruiting|
|Leuven, Belgium, 3000|
|Charles University Pilsen||Recruiting|
|Pilsen, Czechia, 30605|
|Contact: Jiri Bouda, Dr. PhD|
|Klinikum Essen Mitte||Terminated|
|Essen, Germany, 45147|
|Principal Investigator:||Paul Speiser, Prof.,Dr.,MD||Paul SpeiserMedical University Vienna, Dptm. of Obstetrics & Gynaecology|