CADx - Radiomics to Distinguish the Origin of Ovarian Tumors
CADx
Computer-aided Radiology for Cancer Detection and Therapy Stratification - Benign or Malignant Ovarian Tumors.
1 other identifier
observational
600
1 country
5
Brief Summary
In women with an ovarian tumor, it is often unclear whether the tumor is benign or malignant. To differentiate, tumor markers (CA125 and CEA), a transvaginal ultrasound and, depending on the ultrasound image and the CA125 concentration, a CT scan are performed. The quality of radiological imaging in diagnosing abdominal pathology is often not accurate enough, making additional interventions no-dig for proper classification and interpretation of the tumor. Objective: To improve accuracy for distinguishing benign from malignant disease in patients presenting with an ovarian mass by using a computer aided detection algorithm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
Longer than P75 for all trials
5 active sites
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 Start
First participant enrolled
April 5, 2021
CompletedFirst Submitted
Initial submission to the registry
December 13, 2021
CompletedFirst Posted
Study publicly available on registry
December 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedJanuary 25, 2022
January 1, 2022
3.3 years
December 13, 2021
January 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity of CADx algorithm
Percentage of correct determination of malignancy by the Risk of Malignancy Index (RMI) compared to exact determination by CAD assessment in patients with an ovarian tumor
3 - 4 years
Secondary Outcomes (1)
Sensitivity and specificity of CADx algorithm with additional variables
3 - 4 years
Interventions
CADx model was developed with a Support Vector Machine (SVM) algorithm and trained using five-fold cross-validation
Eligibility Criteria
Patients with an ovarian tumor of which it is unknown whether it is benign or malignant referred for staging laparotomy.
You may qualify if:
- patients with an ovarian tumor of which it is unknown whether it is benign or malignant (Risk of Malignancy Index (RMI) \>200)
- underwent surgery
- histological proof of tumor
You may not qualify if:
- indefinite pathology report
- lack of correct description of staging in OR report when applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynaecologisch Oncologisch Centrum Zuidlead
- The Netherlands Cancer Institutecollaborator
- Eindhoven University of Technologycollaborator
- Amsterdam UMC, location VUmccollaborator
- Leiden University Medical Centercollaborator
- Amphia Hospitalcollaborator
Study Sites (5)
Catharina hospital
Eindhoven, North Brabant, 5623EJ, Netherlands
Netherlands Cancer Institute
Amsterdam, North Holland, 1066 CX, Netherlands
Leiden University Medical Center
Leiden, North Holland, 2333 ZA, Netherlands
Amsterdam medical center
Amsterdam, Netherlands
Amphia hospital
Breda, Netherlands
Related Links
Biospecimen
blood based liquid biopsies such ctDNA and tumor DNA.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD-PhD
Study Record Dates
First Submitted
December 13, 2021
First Posted
December 30, 2021
Study Start
April 5, 2021
Primary Completion
August 1, 2024
Study Completion
August 1, 2025
Last Updated
January 25, 2022
Record last verified: 2022-01