Multicenter Validation of the PREDICT Score

Multicenter Validation of the PREDICT Score for Prediction of Local Recurrence After Total Mesorectal Excision of Rectal Cancer

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

Study Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Diagnostic test: PREDICT score

• Study Type: Observational
• Enrollment (Actual): 262

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansourah, Dakahlia, Egypt, 35516
      • Mansoura University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with stage I-III rectal cancer who underwent surgery with curative intent

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with recurrence after TME; Patients who developed local recurrence after TME of rectal cancer	Diagnostic test: PREDICT score; Predictive score for local recurrence after TME for rectal cancer that includes 8 parameters
Patients without recurrence after TME; Patients who did not develop local recurrence after TME of rectal cancer	Diagnostic test: PREDICT score; Predictive score for local recurrence after TME for rectal cancer that includes 8 parameters

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Sameh H Emile, M.D., FACS, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2008
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: October 2, 2021
• First Submitted That Met QC Criteria: October 2, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 2, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: Mansoura2020110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No