Multicenter Validation of the PREDICT Score

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PREDICT score

Diagnostic Test

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

Primary outcomes

Sensitivity of PREDICT score

Time frame: 36 months after surgery

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

Time frame: 36 months after surgery

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2018
Study completion: 2021
First posted: Oct 14, 2021
Registry last updated: Oct 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed