Liquid Biopsies for Improving the Pre-operative Diagnosis of Ovarian Cancer

Summary

An accurate preoperative diagnosis of an ovarian tumor is important for the patients' surgical work-up, proper referral to oncological centers and for the patients' mental wellbeing since uncertainty about the nature (benign vs malignant) of an ovarian tumor may cause anxiety. Currently, the Risk of Malignancy Index (RMI), with a cut-off value of 200, is often used in the Netherlands to select patients with an increased risk of ovarian cancer that should be referred to an oncologic center. However sensitivity and specificity of the RMI-score are far from optimal. Around 40% of the referred patients have benign disease in final pathological examination. Therefore, other models have been developed, such as the IOTA (International Ovarian Tumor Analysis) consortium algorithms, but these models require training, expertise and are subjective. To determine the nature of an ovarian tumor, histological examination is the golden standard. However, a pre-operative biopsy of an ovarian tumor is undesirable because of the risk of spill of tumor cells in the abdominal cavity. Therefore, there is an urgent need for non-invasive diagnostic tools to determine the nature of an ovarian tumor pre-operatively. Liquid biopsies could be such a non-invasive tool. Currently, circulating tumor DNA (ctDNA) circulating tumor cells (CTC), microRNA (miRNA) and tumor-educated platelets (TEPs) are available and can function as a potential blood-based biosource for (early) cancer diagnostics. Previous studies show promising results of liquid biopsies are used in (early) detection of cancer, also for ovarian cancer.

Therefore, a diagnostic algorithm will be developed using ct-DNA and TEPs as liquid biomarkers in combination with the existing ultrasound models (RMI and IOTA-models) and tumor markers (CA125 and HE4) to differentiate between early ovarian cancer and benign ovarian tumors pre-operatively.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness. There is no extra burden/risk for the patients in this study. Five extra vials of blood will be collected from each participant and two questionnaires will be filled out.

Conditions

• Ovarian Neoplasms

Interventions

DIAGNOSTIC_TEST

ctDNA - circulating tumor DNA

lcWGS and WGS of circulating tumor DNA

DIAGNOSTIC_TEST

TEP - Tumor Educated Platelets

sequencing miRNA from TEPs

Sponsors & Collaborators

• Leiden University Medical Center

  collaborator OTHER

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• Amsterdam UMC, location VUmc

  collaborator OTHER

• Delft Technical University

  collaborator UNKNOWN

• Johns Hopkins University

  collaborator OTHER

• Amphia Hospital

  collaborator OTHER

• Reinier de Graaf Groep

  collaborator OTHER

• Haga Hospital

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• The Netherlands Cancer Institute

  lead OTHER

Principal Investigators

• C.A.R. Lok MD, PhD · Dutch Cancer Institute

• C.D. de Kroon · Leiden University Medical Center / Gynecology

• J.M.J. Piek · Catharina Ziekenhuis Eindhoven / Gy-necology

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-04-14

Primary Completion

2024-08-01

Completion

2024-10-01

Countries

• Netherlands

Study Locations