Condition category
Cancer
Date applied
19/11/2015
Date assigned
24/11/2015
Last edited
24/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
In patients with high grade serous epithelial cancer (i.e. involving cancer cells lining a cavity that contains fluid – such as the abdominal cavity - that look very abnormal and growing aggressively) of the ovaries, fallopian tubes or serous peritoneal (lining of the abdomen) cancer the risk of BRCA 1/2 gene mutations is up to 22%. Mutations of BRCA 1/2 genes can be either germline (inherited) or somatic (mutations caused by, for example, exposure to chemicals). Recently, a new targeted drug called olaparib has been approved for treatment of relapsed (cancer that, having gone into remission after treatment has come back) high-grade serous cancer of the ovaries, fallopian tubes or peritoneum in patients with known BRCA 1/2 gene mutations (either germline or somatic).
At the moment the testing for BRCA 1/2 gene mutations is provided from blood sample analysis (after prior genetic counselling) providing information about germline mutations only. For somatic mutations of BRCA 1/2 genes, samples of tumor tissue (paraffin-embeded samples) are recommended. However, it is known that paraffin causes difficulties in determining genetic mutations from tumor tissues. The aim of this study is to determine if cytology material (body cells) obtained from malignant ascites (fluid build-up resulting from cancer) provides the same quality of tumor DNA than material obtained from tumor tissue for detection of BRCA 1/2 somatic gene mutations in patients with high-grade serous epithelial carcinoma of ovaries, fallopian tubes or serous peritoneal carcinoma.

Who can participate?
Women with malignant ascites caused by high-grade serous epithelial carcinoma of the ovaries, fallopian tubes or serous peritoneal carcinoma (cancer of the lining of the abdomen).

What does the study involve?
Participants are asked to give blood, tumor tissue (paraffin-embeded) and ascites (fluid) samples. These samples are then analysed for BRCA 1/2 gene mutations. From ascites and tumor tissue information about somatic BRCA 1/2 gene mutations are provided, whereas from blood sample information about germline mutations of BRCA 1/2 gene mutations are provided.

What are the possible benefits and risks of participating?
None - no influence on standard treatment.

Where is the study run from?
Institute of Oncology Ljubljana (Slovenia)

When is the study starting and how long is it expected to run for?
From October 2015 to December 2017

Who is funding the study?
1. Institute of Oncology Ljubljana (Slovenia)
2. AstraZeneca UK

Who is the main contact?
Dr. Erik Škof

Trial website

Contact information

Type

Scientific

Primary contact

Dr Erik Skof

ORCID ID

Contact details

Department for Medical Oncology
Institute of Oncology Ljubljana
Zaloska 2
Ljubljana
1000
Slovenia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Can cytology replace tumor tissue in determining somatic mutations of BRCA 1/2 genes in patients with epithelial carcinoma of ovaries, fallopian tubes or peritoneal serous carcinoma? A single-centre diagnostic trial

Acronym

Study hypothesis

Cytology material obtained from malignant ascites provides the same quality of tumor DNA than material obtained from tumor tissue for detection of BRCA 1/2 somatic gene mutations in patients with epithelial carcinoma of ovaries, fallopian tubes or serous peritoneal carcinoma

Ethics approval

1. The Republic of Slovenia Commission for Medical Ethics (Komisija Republike Slovenije za Medicinsko Etiko), 27/ 07/ 2015, ref: KME 100/05/15
2. Republic of Slovenia National Medical Ethics Committee, 27/07/2015, ref: NMEC 100/05/15

Study design

Single-centre diagnostic trial

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Malignant ascites in patients with high grade serous cancer of ovaries, fallopian tubes or peritoneal serous cancer

Intervention

In each eligible patient, testing for somatic BRCA 1/2 gene mutations will be provided from malignant ascites and tumor tissue (paraffin block) and testing for germline BRCA 1/2 gene mutations from a blood sample.

Intervention type

Genetic

Phase

Drug names

Primary outcome measures

Determination of somatic BRCA 1/2 gene mutations from cytology material provided from malignant ascites and tumor tissue - 100% correlation expected, proper method to be identified.

Secondary outcome measures

N/A

Overall trial start date

01/02/2015

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Malignant ascites determined by cytology
2. Histology proven high-grade serous cancer of ovaries, fallopian tubes or serous peritoneal cancer

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

40

Participant exclusion criteria

1. Non-malignant ascites
2. Histology other than high-grade serous cancer of ovaries, fallopian tubes or serous peritoneal cancer

Recruitment start date

01/10/2015

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Slovakia, Slovenia

Trial participating centre

Institute Of Oncology Ljubljana
Zaloska 2
Ljubljana
1000
Slovenia

Sponsor information

Organisation

Institute of Oncology Ljubljana

Sponsor details

Zaloska 2
Ljubljana
1000
Slovenia

Sponsor type

Hospital/treatment centre

Website

www.onko-i.si

Funders

Funder type

Hospital/treatment centre

Funder name

Institute Of Oncology Ljubljana (Slovenia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

AstraZeneca

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Annual ASCO or ESMO meeting – preliminary results in 2017
Scientific paper with significant SCI after end of trial

Intention to publish date

01/06/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes