Multicenter Validation of the PREDICT Score

NCT05078515 | Completed

• 1 other identifier: Mansoura2020110
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 1

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

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Patients with recurrence after TME

Patients who developed local recurrence after TME of rectal cancer

Diagnostic Test: PREDICT score

Patients without recurrence after TME

Patients who did not develop local recurrence after TME of rectal cancer

Diagnostic Test: PREDICT score

Interventions

PREDICT score DIAGNOSTIC_TEST

Predictive score for local recurrence after TME for rectal cancer that includes 8 parameters

Patients with recurrence after TME; Patients without recurrence after TME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Sameh H Emile, M.D., FACS

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of surgery

Study Record Dates

• First Submitted: October 2, 2021
• First Posted: October 14, 2021
• Study Start: January 1, 2008
• Primary Completion: December 31, 2018
• Study Completion: August 1, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)