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Multicenter Validation of the PREDICT Score

NCT ID: NCT05078515

Last Updated: 2021-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

262 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-01

Study Completion Date

2021-08-01

Brief Summary

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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

Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with recurrence after TME

Patients who developed local recurrence after TME of rectal cancer

PREDICT score

Intervention Type DIAGNOSTIC_TEST

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

PREDICT score

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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PREDICT score

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Sameh Emile

Associate professor of surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sameh H Emile, M.D., FACS

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Mansoura2020110

Identifier Type: -

Identifier Source: org_study_id