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NCT05534841 Clinical Trial

Assessment of Complete Response MRI Criterion After Neoadjuvant Therapy in Locally Advanced Rectal Cancer

Rectal Neoplasms Clinical Trial

Official title:
Assessment of Complete Response MRI Criterion After Neoadjuvant Therapy in Locally Advanced Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05534841
Other study ID # 22.03.05
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date August 12, 2022

Study information
Verified date September 2022
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Standard care for locally advanced rectal cancer consists in a neoadjuvant therapy followed by surgery. Morbidity and mortality remain high after rectal surgery, and often linked with quality of life impairment. 10 to 30% present a pathological complete response after neoadjuvant therapy. Some surgical teams propose "watch and wait" approach for patients selected with clinical complete responses criterion. The problem is to be sur the response is complete. MRI seems to be accurate to select complete responders. We will try to find MRI criterion of complete responses.

Recruitment information / eligibility
Status Completed
Enrollment 99
Est. completion date August 12, 2022
Est. primary completion date August 12, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Rectal adenocarcinoma - Locally advanced - Neoadjuvant therapy - MRI restaging - Rectal surgery - Definitive anatomopathology study

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Chu de Nîmes Nîmes Gard

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Complete response MRI criterion We selected several objective MRI criterion among literature and compared them between the two groups. Day 0: immediately after the procedure
Secondary MRI accuracy Calculated Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value. Day 0: immediately after the procedure
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