Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
322

Summary

Conditions
Rectal Cancer
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Description

This is a multicenter, prospective, observational clinical study for seeking out a better way to predict the pathologic complete response (pCR) in patients with locally advanced rectal cancer (LARC) based on the post-neoadjuvant treatment Magnetic Resonance Imaging (MRI) data. Patients who have been...

This is a multicenter, prospective, observational clinical study for seeking out a better way to predict the pathologic complete response (pCR) in patients with locally advanced rectal cancer (LARC) based on the post-neoadjuvant treatment Magnetic Resonance Imaging (MRI) data. Patients who have been pathologically diagnosed as rectal adenocarcinoma and defined as clinical II-III stage will be enrolled from the Sixth Affiliated Hospital of Sun Yat-sen University, Sir Run Run Shaw Hospital and the Third Affiliated Hospital of Kunming Medical College. All participants should follow a standard treatment protocol, including neoadjuvant treatment, total mesorectum excision (TME) surgery. Patients with LARC who received neoadjuvant treatment will be enrolled and their post-neoadjuvant treatment MRI images will be used to predict their pathologic response (pCR vs. non-pCR). The artificial intelligence prediction system and the expert radiologist will define the pathologic response as pCR or non-pCR, respectively. The pathologist will provide the final pathology report of TME surgery specimen (pCR or non-pCR) as a standard. The predictive efficacy of these two back-to-back approaches generated will be compared in this multicenter, prospective clinical study.

Tracking Information

NCT #
NCT04278274
Collaborators
  • Sir Run Run Shaw Hospital
  • The Third Affiliated Hospital of Kunming Medical College.
Investigators
Study Chair: Xiangbo Wan, MD, PhD Sixth Affiliated Hospital, Sun Yat-sen University Principal Investigator: Weidong Han, MD, PhD Sir Run Run Shaw Hospital Principal Investigator: Zhenhui Li, MD The Third Affiliated Hospital of Kunming Medical College.