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?

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN42408038

Enrollment

Registered

2015-11-24

Start date

2015-10-01

Completion date

Unknown

Last updated

2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Slovakia, Slovenia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 21, 2026