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

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Completed
CT.gov ID
NCT05534841
Collaborator
(none)
99
Enrollment
1
Location
4.4
Actual Duration (Months)
22.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    99 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Assessment of Complete Response MRI Criterion After Neoadjuvant Therapy in Locally Advanced Rectal Cancer
    Actual Study Start Date :
    Apr 1, 2022
    Actual Primary Completion Date :
    Aug 12, 2022
    Actual Study Completion Date :
    Aug 12, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Pathological complete response

    Patients with a complete response to the neoadjuvant therapy on the definitive anatomopathology study.
    Non pathological complete response

    Patients without complete response to the neoadjuvant therapy on the definitive anatomopathology study.

    Outcome Measures

    Primary Outcome Measures

    1. Complete response MRI criterion [Day 0: immediately after the procedure]

      We selected several objective MRI criterion among literature and compared them between the two groups.

    Secondary Outcome Measures

    1. MRI accuracy [Day 0: immediately after the procedure]

      Calculated Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Rectal adenocarcinoma

    • Locally advanced

    • Neoadjuvant therapy

    • MRI restaging

    • Rectal surgery

    • Definitive anatomopathology study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chu de Nîmes Nîmes Gard France 30000

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Nīmes

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Nīmes
    ClinicalTrials.gov Identifier:
    NCT05534841
    Other Study ID Numbers:
    • 22.03.05
    First Posted:
    Sep 10, 2022
    Last Update Posted:
    Sep 10, 2022
    Last Verified:
    Sep 1, 2022
    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
    Keywords provided by Centre Hospitalier Universitaire de Nīmes
    MRI
    Complete response
    Additional relevant MeSH terms:
    Rectal Neoplasms

    Study Results

    No Results Posted as of Sep 10, 2022