Multicenter Validation of the PREDICT Score

Completed

• Conditions: Rectal Cancer
• Interventions: Diagnostic Test: PREDICT score

• Registration Number: NCT05078515
• Lead Sponsor: Mansoura University

Brief Summary

Even after adequate TME with grade III mesorectal grading, local recurrence remains a possible event. Several studies investigated different parameters and assessed their predictive power in regards to local recurrence after TME. These parameters included a variety of patient-related, tumor-related, and treatment-related factors. A recent meta-analysis reviewed the current literature for the predictors of local recurrence after TME for rectal cancer and developed a prognostic scoring system, the PREDICT score.

The present study aimed to validate the PREDICT scoring system by applying it to a prospective cohort of patients with rectal cancer who underwent curative TME in three

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2021-08-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-02
• Study First Submitted QC: 2021-10-02
• Last Update Submitted: 2021-10-02
• Study First Posted: 2021-10-14
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

Inclusion Criteria

• Adult patients of either sex with non-metastatic low or middle rectal cancer who underwent elective TME with curative intent

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Exclusion Criteria

• Patients with recurrent or metastatic rectal cancer at the time of presentation
• Patients with synchronous colon cancer
• Patients with missing data on the outcome of TME.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with recurrence after TME	PREDICT score	Patients who developed local recurrence after TME of rectal cancer
Patients without recurrence after TME	PREDICT score	Patients who did not develop local recurrence after TME of rectal cancer

Primary Outcome Measures

Name	Time	Method
Specificity of PREDICT score	36 months after surgery	The ability of the score to predict patients who did not experience recurrence after TME
Sensitivity of PREDICT score	36 months after surgery	The ability of the score to predict actual cases of recurrence after TME

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansourah, Dakahlia, Egypt