NCT04511481

Brief Summary

Platinum-sensitive is an important basis for the treatment of recurrent epithelial ovarian cancer (EOC) without effective methods to predict.We aimed to develop and validate the EOC deep learning system to predict the platinum-sensitive of EOC patients through analysis of enhanced magnetic resonance imaging (MRI) images before initial treatment.Ninety-three EOC patients received platinum-based chemotherapy (\>= 4 cycles) and debulking surgery from Sun Yat-sen Memorial Hospitalin China from January 2011 to January 2020 were enrolled. This deep-learning EOC signature achieved a high predictive power for platinum-sensitive, and the signature based on MRI whole volume is better than that on primary tumor area only.

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
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

August 11, 2020

Last Update Submit

August 11, 2020

Conditions

Predictive Cancer Model

Outcome Measures

Primary Outcomes (1)

  • Platinum sensitivity

    Platinum sensitivity

    9 years

Study Arms (2)

platinum-resistant group

Other: Radiomic Algorithm

platinum-sensitive group

Other: Radiomic Algorithm

Interventions

Radiomic AlgorithmOTHER

Different radiomic and machine learning strategies for radiomic features extraction, sorting features and model constriction

platinum-resistant groupplatinum-sensitive group

Eligibility Criteria

Age22 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients received platinum-based chemotherapy (\>= 4 cycles) and debulking surgery from Sun Yat-sen Memorial Hospital in China from January 2011 to January 2020

You may qualify if:

  • (1)Patients with epithelial ovarian cancer (2 )Patients received platinum-based chemotherapy (\>= 4 cycles) and debulking surgery

You may not qualify if:

  • Patients with epithelial ovarian cancer received less than 4 cycles platinum-based chemotherapy or no debulking surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

Central Study Contacts

Ruilin Lei, phD

CONTACT

+8618898325866leiruilin1988@163.com

Study Design

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

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 13, 2020

Study Start

April 15, 2020

Primary Completion

August 3, 2020

Study Completion

January 1, 2021

Last Updated

August 13, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

The datasets used or analysed during the current study are available from the corresponding author on reasonable request.

Locations

CN(1)