Constructing a Multimodal Imaging System to Predict the Risk of Heterochronous Metastasis of Rectal Cancer

NCT06293612 | Completed DMC

• 4 other identifiers: 22/449-36512022-I2M-C&T-B-0777244398Beijing Hope Run Special Fund
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to construct a multimodal intelligent model to predict the risk of heterochronous metastasis of rectal cancer, which is helpful for individualized diagnosis and treatment and follow-up planning. The main questions it aims to answer are:

• what are the independent risk factors of distant metastasis (DM) in locally advanced rectal cancer (LARC)
• What is the influence weight of the above factors on the heterochronous metastasis of LARC, and how to build a risk-prediction model This study will not affect or interfere with the routine medical diagnosis and treatment of participants, and will not increase the cost and risk of participants. Participant's information is protected and identified by a unique code.

Conditions

Locally Advanced Rectal Cancer; Distant Metastasis

Keywords

locally advanced rectal cancer; distant metastases; tumor stromal ratio; magnetic resonance imaging; artificial intelligence

Outcome Measures

Primary Outcomes (1)

• Heterochronous distant metastasis

  Defined as cancer recurrence at sites outside the pelvis based on radiological and/or histopathological evidence.

  Through study completion, an average of 3 years

Secondary Outcomes (1)

• Distant metastasis-free survival

  From the date of surgery to the date of the first detection of distant metastasis, death from any cause, assessed up to 3 years.

Study Arms (2)

Training cohort

The patients were randomized into a training cohort (n ＝ 211) to train the model. The patients' clinicopathological data were reviewed, including age, sex, obesity, serum carcinoembryonic antigen and cancer antigen 19-9 levels, T- and N-stages evaluated by MRI, yp-T and yp-N stages evaluated by histopathology. The MR-T/N stages of the tumors were assessed by radiologists. The tumor region of interest was manually delineated on high-resolution oblique axial T2WI and generated the VOI using ITK-SNAP. Overall, 1229 features were extracted from each VOI. Biopsy specimens from colonoscopy were sectioned into 5 μm slices and stained with H\&E. Areas with both stromal and tumor cells presented on all four sides were selected to evaluate tumor stroma ratio using an automated scoring method with the highest proportion of stromal components in all measured areas recorded.

Other: No intervention was administrated to the two cohorts.

Validation cohort

The patients were randomized into a validation cohort (n ＝91) to verify the model. The patients' clinicopathological data were reviewed, including age, sex, obesity, serum carcinoembryonic antigen and cancer antigen 19-9 levels, T- and N-stages evaluated by MRI, yp-T and yp-N stages evaluated by histopathology. The MR-T/N stages of the tumors were assessed by radiologists. The tumor region of interest was manually delineated on high-resolution oblique axial T2WI and generated the VOI using ITK-SNAP. Overall, 1229 features were extracted from each VOI. Biopsy specimens from colonoscopy were sectioned into 5 μm slices and stained with H\&E. Areas with both stromal and tumor cells presented on all four sides were selected to evaluate tumor stroma ratio using an automated scoring method with the highest proportion of stromal components in all measured areas recorded.

Other: No intervention was administrated to the two cohorts.

Interventions

No intervention was administrated to the two cohorts. OTHER

Training cohort; Validation cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive cases of locally advanced rectal adenocarcinoma who were treated with 5-FU or Capecitabine-based concurrent NCRT and total mesorectal excision at our institute between 2015 and 2018 were retrospectively reviewed.

You may qualify if:

• Newly diagnosed non-mucinous LARC (T3\~T4, or any T with N1\~2, M0) without previous treatment;
• No concomitant malignancies or systemic disease;
• Complete standard neoadjuvant chemoradiotherapy (NCRT) and radical surgery in our institute;
• Underwent rectal MRI and colonoscopy within 2 weeks before NCRT.

You may not qualify if:

• Inadequate MR image quality for analysis, or lack of biopsy tissue for TSR assessment;
• Incomplete clinical data or withdraw before last visit.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100021, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

colonoscopic biopsies

Study Officials

• Hongmei Zhang, MD

  National Cancer Center, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: March 5, 2024
• Study Start: January 1, 2015
• Primary Completion: December 31, 2018
• Study Completion: November 30, 2022
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)