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
Study website
Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Hospital
Study 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
Primary outcome measure
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 study start date
01/02/2015
Overall study end date
31/12/2017
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
Study 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
ROR
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)
AstraZeneca PLC, Pearl Therapeutics
Funding Body Type
government organisation
Funding Body Subtype
For-profit companies (industry)
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
Individual participant data (IPD) sharing plan
The data-sharing plans for the current study are unknown and will be made available at a later date
IPD sharing plan summary
Data sharing statement to be made available at a later date
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/04/2019 | Yes | No | |
| Other publications | 10/03/2022 | 03/01/2023 | Yes | No |