DISARM Clinical Study B: Evaluation of Innovative Ovarian Cancer Biomarker Assays

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age35+
SponsorNational and Kapodistrian University of Athens

About this trial

Ovarian cancer is often diagnosed at a later stage because early symptoms can be mild or non-specific. Earlier detection of ovarian cancer could improve treatment options and outcomes.

Recent research has focused on the development of blood-based tests, sometimes referred to as liquid biopsy tests, which aim to look for changes in the blood that could be linked to cancer. These tests are still under investigation and are not part of routine clinical care.

The purpose of this study is to evaluate several blood-based ovarian cancer tests. This will be done by comparing test results from people who have ovarian cancer with results from people who do not have cancer.

The study will also collect information from standard blood tests and genetic analyses to better understand how these results relate to ovarian cancer.

This study is for research purposes only. The blood-based tests being evaluated are investigational and are not used to make medical decisions or diagnoses for women taking part in the study.

Eligibility criteria

Qualifiers

Women, trans men and non-binary people with female reproductive organs

Aged ≥35 years*

Pathologically diagnosed, by biopsy, with EOC prior to surgical intervention or treatment

Presenting with adnexal mass suspicious of OC on imaging and scheduled for surgical resection or biopsy (and subsequent confirmation of EOC)

Disqualifiers

Prior history and any treatment for malignancy

Prior removal of either ovary for any reason

Pregnant or lactating

Any condition or circumstance that, in the opinion of the investigator, could interfere with the participant's ability to participate or comply with study requirements

Trial design

Treatments tested in this trial

  • Investigational ovarian cancer biomarker assays

Treatment groups

2,080 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators