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

NCT05534841 | Completed

• 1 other identifier: 22.03.05
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Neoplasms

Keywords

MRI; Complete response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• MRI accuracy

  Day 0: immediately after the procedure

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Digestive surgery department

You may qualify if:

• Rectal adenocarcinoma
• Locally advanced
• Neoadjuvant therapy
• MRI restaging
• Rectal surgery
• Definitive anatomopathology study

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Chu de Nîmes

Nîmes, GARD, 30000, France

Location

MeSH Terms

Conditions

Rectal Neoplasms; Pathologic Complete Response

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; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 10, 2022
• Study Start: April 1, 2022
• Primary Completion: August 12, 2022
• Study Completion: August 12, 2022
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)