Lavage of the Uterine Cavity for the Diagnosis of Serous Tubal Intraepithelial Carcinoma

NCT02039388 | Completed

• 1 other identifier: EK 1766/2013
• Study Type: interventional
• Target: 701
• Locations: 8 countries
• Sites: 14

Brief Summary

The current study aims at answering the scientific question, whether exfoliated cells from STICs get transported into the uterine cavity via the fallopian tube, and whether it is possible to detect those cells in the lavage fluid from the uterine cavity and proximal fallopian tubes. To address this question, the investigators will study 20 lavage samples and their 20 corresponding STIC-positive tissue samples in women who opt for risk-reducing bilateral salpingo-oophorectomy (rrBSO) because of increased risk of high grade serous carcinoma of the pelvis (HGSC) (mostly carrying a BRCA mutation), without a history of tubal occlusion for sterilization. Women who opt to have the fallopian tubes removed but the ovaries preserved are eligible for the study too, as are women who opt for rrBSO plus hysterectomy.

Conditions

Ovarian Epithelial Cancer; Carcinoma in Situ; Ovarian Cancer

Keywords

Ovarian Epithelial Cancer; Serous Intraepithelial Carcinoma (STIC); BRCA1 gene; BRCA2 gene; Mutation; Neoplasms; Glandular and Epithelial; Ovarian Neoplasms; Ovarian cancer; Carcinoma in situ; family history breast cancer; family history ovarian cancer

Outcome Measures

Primary Outcomes (1)

• Detection of "Serous Tubal Intraepithelial Carcinomas (STICs)" in the lavage fluid from the uterine cavity and proximal fallopian tubes.

  Women who opt for rrBSO or opt to have the fallopian tubes removed but the ovaries preserved, and women who opt for rrBSO plus hysterectomy. The lavage can be done either in an outpatient setting or in the operating theatre under general anaesthesia.

  preoperative

Study Arms (1)

High risk patients for breast and/or ovarian cancer

OTHER

Procedure: Lavage of the Cavum uteri and proximal Fallopian tubes, performed in the luteal phase of the female cycle

Interventions

Lavage of the Cavum uteri and proximal Fallopian tubes, performed in the luteal phase of the female cycle PROCEDURE

High risk patients for breast and/or ovarian cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BRCA1/2 mutation carriers
• strong family history of breast and/or ovarian cancer suggestive for a germ line mutation in a relevant gene

You may not qualify if:

• pregnant
• incapacitated persons

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (14)

Medical University Graz - Universitätsklinik f. Frauenheilkunde u. Geburtshilfe

Graz, 8036, Austria

Location

Kepler University Linz

Linz, 4040, Austria

Location

Medical University Vienna, Dptm. of Obstetrics & Gynaecology

Vienna, 1090, Austria

Location

Catholic University Leuven - Department of Obstetrics and Gynaecology

Leuven, 3000, Belgium

Location

Gynecological Oncology Center Department of Obstetrics and Gynecology Charles University in Prague

Prague, Prague 2, 12800, Czechia

Location

Masaryk Memorial Cancer Institute Brno

Brno, 60200, Czechia

Location

Charles University Pilsen

Pilsen, 30605, Czechia

Location

Copenhagen University Hospital Rigshospitalet

Copenhagen, 2100, Denmark

Location

Charité Univ., Berlin-Campus Virchow Clinic

Berlin, 13353, Germany

Location

Klinik Essen Mitte (KEM)

Essen, 92 45136, Germany

Location

Clinical Center University of Munich

München, 80799, Germany

Location

Trinity Centre for Health Sciences St. James's Hospital

Dublin, 8, Ireland

Location

Radboud University Medical Centre

Nijmegen, 6525 GA, Netherlands

Location

University College London Cancer Institute

London, WC1E 6HX, United Kingdom

Location

Related Publications (1)

• Maritschnegg E, Wang Y, Pecha N, Horvat R, Van Nieuwenhuysen E, Vergote I, Heitz F, Sehouli J, Kinde I, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Speiser P, Zeillinger R. Lavage of the Uterine Cavity for Molecular Detection of Mullerian Duct Carcinomas: A Proof-of-Concept Study. J Clin Oncol. 2015 Dec 20;33(36):4293-300. doi: 10.1200/JCO.2015.61.3083. Epub 2015 Nov 9.

  PMID: 26552420 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Carcinoma in Situ; Ovarian Neoplasms; Fanconi Anemia, Complementation Group D1; Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Paul Speiser, Univ.Prof.Dr.med.

  Medical University Vienna, Dptm. of Obstetrics & Gynaecology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 16, 2014
• First Posted: January 17, 2014
• Study Start: November 1, 2013
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 2, 2022

Record last verified: 2022-09

Locations

IE (1); NL (1); GB (1); CZ (3); DK (1); BE (1); AU (3); DE (3)