NCT05808933

Brief Summary

The aim of this observational prospective study is to investigate the role of Magnetic Resonance Fingerprinting in preoperative assessment of early cervical cancer

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress71%
Jun 2022Dec 2027

Study Start

First participant enrolled

June 20, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 12, 2023

Status Verified

March 1, 2023

Enrollment Period

5.5 years

First QC Date

March 6, 2023

Last Update Submit

March 29, 2023

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

  • Association between T1-, T2- and ADC-maps and LVSI status

    3 months

Secondary Outcomes (2)

  • Correlation between T1-, T2- and ADC-maps and DFS and OS

    3 years

  • Correlation between Radiomics-based analysis and LVSI status and DFS and OS

    3 years

Eligibility Criteria

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

Patients with a diagnosis of cervical cancer (FIGO IA-IIA) that will undergo to surgery at Fondazione Policlinico Universitario "A. Gemelli" IRCCS can be included in this study, according to inclusion and exclusion criteria

You may qualify if:

  • Patients with biopsy-proven cervical cancer FIGO stage IA-IIA undergoing surgery;
  • Women aged \>18 years old;
  • Signed Informed Consent.

You may not qualify if:

  • Concurrent malignancies at other sites;
  • Previous history of neoplasm;
  • Refusal to sign written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitaro "A. Gemelli" IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Benedetta B Gui, MD

CONTACT

0630155464benedetta.gui@policlinicogemelli.it

Luca L Russo, MD

CONTACT

0630156054luca.russo@guest.policlinicogemelli.it

Study Design

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

Study Record Dates

First Submitted

March 6, 2023

First Posted

April 12, 2023

Study Start

June 20, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 12, 2023

Record last verified: 2023-03

Locations

IT(1)