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NCT05078515 Clinical Trial

Multicenter Validation of the PREDICT Score

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05078515
Other study ID # Mansoura2020110
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2008
Est. completion date August 1, 2021

Study information
Verified date October 2021
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 262
Est. completion date August 1, 2021
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• PREDICT score
Predictive score for local recurrence after TME for rectal cancer that includes 8 parameters

Locations
Country Name City State
Egypt Mansoura university hospital Mansourah Dakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

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