AI-Based Prediction of Pathological Response in Rectal Cancer Patients Receiving Total Neoadjuvant Therapy

NCT07049627 | Completed

• 1 other identifier: AEŞH-BADEK-2024-628
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to better understand how body composition, inflammation, and nutrition affect how rectal cancer responds to treatment. We reviewed data from ninety-three patients who were treated with total neoadjuvant therapy (TNT), which includes both chemotherapy and radiation before surgery. Using blood tests and CT scans, we measured muscle loss (sarcopenia), inflammation, and nutritional status before and after treatment. This study aims to better understand how body composition, inflammation, and nutrition affect rectal cancer response to treatment. We retrospectively analyzed data from ninety-three patients who received total neoadjuvant therapy (TNT), including both chemotherapy and radiation prior to surgery. Blood tests and CT scans were used to assess inflammation, nutrition, and muscle loss (sarcopenia) before and after treatment. The objective was to identify predictors of complete pathological response. Two novel composite scores were developed from routine lab parameters and tested for their predictive value. Artificial intelligence (AI) was also applied to enhance model accuracy. This study was conducted at Etlik City Hospital in Ankara, Turkey. No experimental interventions were performed. All data were obtained from routine care, and no additional procedures or patient compensation were involved. The findings may support personalized treatment decisions in rectal cancer.

Conditions

Locally Advanced Rectal Cancer (LARC)

Keywords

Rectal Cancer; Total Neoadjuvant Therapy; Sarcopenia; Artificial Intelligence; Machine Learning

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR)

  Proportion of patients achieving ypT0N0 following TNT and surgery

  Within 16-24 weeks after TNT completion

Secondary Outcomes (1)

• Good Pathological Response (TRG 0-1)

  Within 16-24 weeks after TNT completion

Study Arms (1)

Patients with Locally Advanced Rectal Cancer Treated with TNT

This cohort includes 93 patients with clinical stage II-III locally advanced rectal cancer who received total neoadjuvant therapy (TNT), consisting of both systemic chemotherapy and radiotherapy, followed by curative-intent surgery. Patients were retrospectively analyzed to evaluate the predictive role of inflammatory, nutritional, and sarcopenia-based biomarkers on pathological response. No new intervention was administered as part of this study.

Other: Total Neoadjuvant Therapy (TNT)

Interventions

Total Neoadjuvant Therapy (TNT) OTHER

Patients included in this retrospective cohort received total neoadjuvant therapy (TNT), consisting of systemic chemotherapy and radiotherapy, followed by curative-intent surgery. No experimental interventions were applied. The analysis focused on evaluating clinical, inflammatory, nutritional, and sarcopenia-based predictors of pathological response.

Patients with Locally Advanced Rectal Cancer Treated with TNT

Eligibility Criteria

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

Study Population

This retrospective cohort study evaluates pathological response in rectal cancer patients receiving total neoadjuvant therapy (TNT). It integrates systemic inflammation (CAR, SII), nutritional status, and CT-based sarcopenia assessments with both logistic regression and AI (Random Forest) modeling. Two novel composite scores (CINR-pCR and CINR-Ryan) were developed. The study was conducted at Etlik City Hospital, Türkiye, including ninety-three patients between November 2022 and December 2024.

You may qualify if:

• Age ≥ 18 years
• All sexes eligible
• Histologically confirmed clinical stage II-III rectal adenocarcinoma
• Completion of total neoadjuvant therapy (TNT), defined as:
• ≥12 weeks of systemic therapy and
• Radiotherapy (RT) completed
• Curative-intent surgery performed
• Availability of both pre- and post-TNT abdominal CT scans for sarcopenia assessment

You may not qualify if:

• Development of distant metastasis during TNT
• Early disease progression
• Missing radiological or pathological data
• Incomplete or non-curative surgery

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (2)

Etlik City Hospital

Ankara, Yenimahalle, 06210, Turkey (Türkiye)

Location

Etlik City Hospital

Ankara, YENİMAHALLE, 06210, Turkey (Türkiye)

Location

Related Publications (1)

• Uyar GC, Basaran BN, Baskurt K, Yesilbas E, Ozkan E, Yucel KB, Altinbas M, Evrimler S, Oksuzoglu OBC, Sutcuoglu O. Predicting Pathologic Response in Locally Advanced Rectal Cancer Using Inflammatory, Nutritional, and Sarcopenia-Based Markers: A Regression and AI-Based Analysis (CINR-AI Study). Clin Colorectal Cancer. 2025 Oct 16:S1533-0028(25)00082-9. doi: 10.1016/j.clcc.2025.10.002. Online ahead of print.

  PMID: 41198426 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms; Sarcopenia

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; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Galip Can Uyar, MD

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: July 3, 2025
• Study Start: November 5, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)