NCT03883542

Brief Summary

The aim of this study is to identify different origin in carcinogenesis between serous borderline ovarian tumors presenting a. without implants, b. with non-invasive implants, c. with invasive implants and d. with micropapillary pattern. The presence of specific mutations could suggest for a more aggressive primary treatment if a higher risk of recurrence can be expected.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
15mo left

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress88%
Jan 2017Jul 2027

Study Start

First participant enrolled

January 1, 2017

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

10 years

First QC Date

February 26, 2019

Last Update Submit

April 28, 2026

Conditions

Ovarian Neoplasm Epithelial

Keywords

low malignant potentialserous

Outcome Measures

Primary Outcomes (1)

  • genetic mutations

    amount and type of genetic mutations in different subgroups will be analyzed and compared between the different subgroups. Are the mutations suggestive for a type I or type II pathway differentiation?

    2020

Study Arms (4)

serous BOT

simple serous BOT ovarian tissue

Genetic: genomic mutations study

serous BOT with non-invasive implants

BOT ovarian tissue presenting with non-invasive implants

Genetic: genomic mutations study

sBOT with micropapillary grow pattern

BOT ovarian tissue presenting with micropapillary grow pattern

Genetic: genomic mutations study

serous BOT with invasive implants

sBOT ovarian tissue presenting with invasive implants at the time of diagnosis

Genetic: genomic mutations study

Interventions

genomic mutations studyGENETIC

Sequencing of the DNA samples extracted from the subgroups 1. serous BOT tissue, 2. serous BOT tissue with non-invasive implants and 3. serous BOT tissue with micropapillary grow pattern will undergo a panel testing for Type 1 genes (small panel 15-40 mutations) AND p53 AND BRCA testing Sequencing of the DNA samples extracted from the serous BOT tissue with invasive implants will undergo a more comprehensive examination (large panel +- 1000 genes checked)

sBOT with micropapillary grow patternserous BOTserous BOT with invasive implantsserous BOT with non-invasive implants

Eligibility Criteria

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

Patients with proven serous bordeline ovarian tumors.

You may qualify if:

  • Paraffin embedded material from the original borderline ovarian tumor must be present and of good quality for DNA extraction.
  • Original slides are available for central pathological review.

You may not qualify if:

  • Presence of invasive ovarian carcinoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis UZBrussel

Jette, Brussels Capital, 1090, Belgium

Location

Related Publications (4)

  • Morice P, Uzan C, Fauvet R, Gouy S, Duvillard P, Darai E. Borderline ovarian tumour: pathological diagnostic dilemma and risk factors for invasive or lethal recurrence. Lancet Oncol. 2012 Mar;13(3):e103-15. doi: 10.1016/S1470-2045(11)70288-1.

    PMID: 22381933BACKGROUND

  • Vang R, Shih IeM, Kurman RJ. Ovarian low-grade and high-grade serous carcinoma: pathogenesis, clinicopathologic and molecular biologic features, and diagnostic problems. Adv Anat Pathol. 2009 Sep;16(5):267-82. doi: 10.1097/PAP.0b013e3181b4fffa.

    PMID: 19700937BACKGROUND

  • Despierre E, Lambrechts D, Neven P, Amant F, Lambrechts S, Vergote I. The molecular genetic basis of ovarian cancer and its roadmap towards a better treatment. Gynecol Oncol. 2010 May;117(2):358-65. doi: 10.1016/j.ygyno.2010.02.012. Epub 2010 Mar 7.

    PMID: 20207398BACKGROUND

  • Kurman RJ, Shih IeM. The origin and pathogenesis of epithelial ovarian cancer: a proposed unifying theory. Am J Surg Pathol. 2010 Mar;34(3):433-43. doi: 10.1097/PAS.0b013e3181cf3d79.

    PMID: 20154587BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Macrodissection of borderline ovarian tumor tissue. DNA extraction from paraffin embedded material for genetic analysis.

Study Officials

  • stef cosyns, dr

    UZBrussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 26, 2019

First Posted

March 21, 2019

Study Start

January 1, 2017

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 30, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)