NCT05815992

Brief Summary

The aim of this prospective observational study is to evaluate the accuracy and to validate the Cambridge Score,a Test Index to predict the malignancy of the ovarian lesions on the basis of an MRI examination without contrast

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
370

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Typical duration 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

September 1, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 18, 2023

Status Verified

March 1, 2023

Enrollment Period

3.3 years

First QC Date

March 29, 2023

Last Update Submit

April 14, 2023

Conditions

Adnexal Mass

Outcome Measures

Primary Outcomes (1)

  • Evaluation of generalizability of the Cambridge Score through external validations

    Through study completion, an average of 3 years

Secondary Outcomes (2)

  • Evaluation of Cambridge Score when diagnosed by different readers

    Through study completion, an average of 3 years

  • Evaluation of diagnostic agreement between the Non-contrast and contrast-enhanced MRI

    Through study completion, an average of 3 years

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women with indeterminate adnexal masses can be included.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a diagnosis of indeterminate adnexal masses after ultrasonography that will undergo to an MRI examination can be included in this study

You may qualify if:

  • Age \> 18 years;
  • Indeterminate adnexal masses at the ultrasonography;
  • Signed Informed Consent.

You may not qualify if:

  • Diagnosis of an extraovary mass;
  • Synchronous tumors;
  • Previous history of neoplasy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitaro "A. Gemelli" IRCCS

Roma, 00168, Italy

RECRUITING

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2023

First Posted

April 18, 2023

Study Start

September 1, 2021

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

April 18, 2023

Record last verified: 2023-03

Locations

IT(1)