NCT04971421

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 14, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

July 21, 2021

Status Verified

June 1, 2021

Enrollment Period

3.3 years

First QC Date

February 17, 2021

Last Update Submit

July 20, 2021

Conditions

Ovarian Neoplasms

Keywords

Ovarian cancertumor educated plateletscirculating tumor DNAdiagnostics

Outcome Measures

Primary Outcomes (1)

  • The diagnostic accuracy of the developed algorithm

    The diagnostic accuracy of the developed algorithm, displayed as sensitivity and specificity.

    3 -4 years

Secondary Outcomes (9)

  • Cost-effective analysis (I)

    3 -4 years

  • Cost-effective analysis (II)

    3 -4 years

  • Cost-effective analysis (III)

    3 -4 years

  • Psychological Burden (I)

    3 -4 years

  • Psychological Burden (II)

    3 -4 years

  • +4 more secondary outcomes

Study Arms (3)

Benign ovarian tumors

All histological proven benign ovarian tumors

Diagnostic Test: ctDNA - circulating tumor DNADiagnostic Test: TEP - Tumor Educated Platelets

Malignant ovarian tumors

All histological proven malignant ovarian tumors

Diagnostic Test: ctDNA - circulating tumor DNADiagnostic Test: TEP - Tumor Educated Platelets

Borderline ovarian tumors

All histological proven borderline ovarian tumors

Diagnostic Test: ctDNA - circulating tumor DNADiagnostic Test: TEP - Tumor Educated Platelets

Interventions

ctDNA - circulating tumor DNADIAGNOSTIC_TEST

lcWGS and WGS of circulating tumor DNA

Benign ovarian tumorsBorderline ovarian tumorsMalignant ovarian tumors
TEP - Tumor Educated PlateletsDIAGNOSTIC_TEST

sequencing miRNA from TEPs

Benign ovarian tumorsBorderline ovarian tumorsMalignant ovarian tumors

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with a suspected malignant ovarian tumor referred to a center for gynecological oncology (CGOA, LUMC or CZE) or one of the four affiliated hospitals (Amphia Ziekenhuis (Breda), HAGA Ziekenhuis (Den Haag), Reinier de Graaf Gasthuis (Delft) of HMC (Den Haag) for surgical treatment.

You may qualify if:

  • Age ≥18 years
  • Presence of a ovarian tumor and referred to specialized center for surgery based on:
  • Any ultrasound model e.g. RMI-scoring model ; IOTA-rules
  • Subjective assessment of the referring gynecologist
  • Normal Glomerular Filtration Rate (GFR): \>60ml/min/1,73m2
  • General criteria: a. Understanding of Dutch language b. Fit for surgery (WHO 1-2) c. Written informed consent

You may not qualify if:

  • Suspicion of advanced-stage of disease, e.g. ascites or peritoneal depositions
  • Multiple malignancies at the same time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dutch Cancer Institute NKI-AVL

Amsterdam, Netherlands

RECRUITING

Amsterdam UMC loc VUmc

Amsterdam-Zuidoost, Netherlands

RECRUITING

Catharina hospital Eindhoven

Eindhoven, Netherlands

RECRUITING

Leiden University Medical Center

Leiden, Netherlands

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tumor-educated platelets (TEPs) and circulating tumor DNA (ctDNA) and postoperative histological tissue

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • C.A.R. Lok MD, PhD

    Dutch Cancer Institute

    PRINCIPAL INVESTIGATOR

  • C.D. de Kroon

    Leiden University Medical Center / Gynecology

    PRINCIPAL INVESTIGATOR

  • J.M.J. Piek

    Catharina Ziekenhuis Eindhoven / Gy-necology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

C.A.R. Lok MD, PhD

CONTACT

00 31 20 512 2975c.lok@nki.nl

A. Koch PhD-candidate

CONTACT

00 31 20 512 4303a.koch@nki.nl

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2021

First Posted

July 21, 2021

Study Start

April 14, 2021

Primary Completion

August 1, 2024

Study Completion

October 1, 2024

Last Updated

July 21, 2021

Record last verified: 2021-06

Locations

NL(4)