NCT02785731

Evaluation of Multiple Biomarkers to Estimate Risk of Ovarian Cancer in Patients With a Pelvic Mass.

Completed Last updated 9 November 2018

What this trial tests

trial testing Pelvic imaging in Ovarian Neoplasms in 204 participants. Completed in 31 July 2018.

Timeline

14 July 2016

Primary endpoint
9 October 2017

31 July 2018

Quick facts

Lead sponsor	Angle plc
Status	Completed
Study type	OBSERVATIONAL
Enrollment	204
Start date	14 July 2016
Primary completion	9 October 2017
Estimated completion	31 July 2018
Sites	5 locations across Austria, Germany

Drugs / interventions tested

• Pelvic imaging
• Blood draw — full drug profile →
• laparotomy or laparoscopy

Conditions studied

• Ovarian Neoplasms — all drugs for Ovarian Neoplasms →

Sponsor

Angle plc

Who can join

18 and older, female only, with Ovarian Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

ANGLE has developed the Parsortix™ Cell Separation System (Parsortix), an automated system capable of harvesting rare circulating cells for analysis from a sample of peripheral blood based on cellular size and deformability. In a small pilot study, scientists at the Medical University of Vienna demonstrated that measurement of a combination of mRNA markers extracted from CTCs captured using the Parsortix system could be used to identify women with ovarian cancer. This study is designed to provide specimens for optimization of an assay using clinical and biomarker information (i.e. demographics, imaging results and/or serum tumor markers) in combination with mRNA extracted from rare cells in the blood of women presenting with a pelvic mass for the detection of malignancy.

Primary Objective: Optimization of an assay for the differentiation of women with benign pelvic masses from those with malignant pelvic masses using mRNA markers extracted from CTCs isolated from whole blood. Multiple serum tumor markers and mRNA markers will be measured, and the results will be compared to the actual clinical diagnosis made for each patient through other recognized methods (e.g. histopathology). The blood samples collected in the course of this study will be used to finalize the selection of mRNA and/or serum tumor markers to be evaluated in future prospective studies.

Exploratory Objective: Use statistical modeling to determine the need for and/or preliminary design of a mathematical algorithm to combine the multiple serum tumor and/or mRNA markers for estimation of the risk of ovarian cancer.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Review of Circulating Tumour Cell Enrichment Technologies.
   Rushton AJ, Nteliopoulos G, Shaw JA, Coombes RC. · · 2021 · cited 126× · PMID 33652649 · DOI 10.3390/cancers13050970
2. The Role of Circulating Tumor Cells in the Metastatic Cascade: Biology, Technical Challenges, and Clinical Relevance.
   Dianat-Moghadam H, Azizi M, Eslami-S Z, Cortés-Hernández LE, et al · · 2020 · cited 63× · PMID 32260071 · DOI 10.3390/cancers12040867
3. EMT-independent detection of circulating tumor cells in human blood samples and pre-clinical mouse models of metastasis.
   Kitz J, Goodale D, Postenka C, Lowes LE, et al · · 2021 · cited 27× · PMID 33415568 · DOI 10.1007/s10585-020-10070-y
4. Fugitives on the run: circulating tumor cells (CTCs) in metastatic diseases.
   Mamdouhi T, Twomey JD, McSweeney KM, Zhang B. · · 2019 · cited 16× · PMID 31053984 · DOI 10.1007/s10555-019-09795-4
5. Through the Looking Glass: Updated Insights on Ovarian Cancer Diagnostics.
   Chakraborty S, Shenoy PS, Mehrotra M, Phadte P, et al · · 2023 · cited 4× · PMID 36832201 · DOI 10.3390/diagnostics13040713