NCT04868097

Brief Summary

A pre- operative evaluation for the presence of intermediate risk factors prior to surgery may allow for better patient counselling, modify the course of surgery or select patients to undergo primary chemo- radiation. The purpose of this study is to validate that the presence of histological risk factors in a pre-operative large loop biopsy highly correlates with post-operative histological evaluation and the subsequent indication for post-operative chemo-radiation

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
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

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 1, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

April 26, 2021

Last Update Submit

April 29, 2021

Conditions

Cancer of the CervixConization of the CervixRadiation Therapy

Keywords

cervix cancer, Radiation

Outcome Measures

Primary Outcomes (1)

  • The rate of LVSI in Cervix cancer

    Pre operative presence of LVSI in loop biopsy in cervical cancer, compared to post operative LVSI rate in hysterectomy Specimen

    two years

Interventions

cervix biopsyPROCEDURE

large loop electrosurgical cervix biopsy

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patient who do not sign the informed consent. Patient who is scheduled for Chemoradiation Patients with large loop biopsy which is smaller than depth of 1.5 and a diameter of 1.0 cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaplan Medical Center

Rehovot, 76100, Israel

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of obstetrics and gynecology department

Study Record Dates

First Submitted

April 26, 2021

First Posted

April 30, 2021

Study Start

April 1, 2021

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)