Multicenter Validation of the PREDICT Score

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05078515
• Collaborator: (none)
• Enrollment: 262
• Location: 1
• Actual Duration (Months): 163
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer	Diagnostic Test: PREDICT score

Study Design

• Study Type: Observational
• Actual Enrollment: 262 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Multicenter Validation of the PREDICT Score for Prediction of Local Recurrence After Total Mesorectal Excision of Rectal Cancer
• Actual Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Aug 1, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Sensitivity of PREDICT score [36 months after surgery]

   The ability of the score to predict actual cases of recurrence after TME

2. Specificity of PREDICT score [36 months after surgery]

   The ability of the score to predict patients who did not experience recurrence after TME

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura university hospital	Mansourah	Dakahlia	Egypt	35516

Sponsors and Collaborators

• Mansoura University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sameh Emile, Associate professor of surgery, Mansoura University
• ClinicalTrials.gov Identifier: NCT05078515
• Other Study ID Numbers: Mansoura2020110
• First Posted: Oct 14, 2021
• Last Update Posted: Oct 14, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Oct 14, 2021