Clinical trial · Observational
AI-Based Prediction of Pathological Response in Rectal Cancer Patients Receiving Total Neoadjuvant Therapy
Inflammatory, Nutritional, and Sarcopenia-Based Prediction of Pathological Response in Local Advanced Rectal Cancer: A Regression and AI Approach
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectal Cancer (LARC) | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Total Neoadjuvant Therapy (TNT) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with Locally Advanced Rectal Cancer Treated with TNT
- description
- 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.
- interventionNames
- Other: Total Neoadjuvant Therapy (TNT)
Primary outcomes (1)
- measure
- Pathological Complete Response (pCR)
- timeFrame
- Within 16-24 weeks after TNT completion
- description
- Proportion of patients achieving ypT0N0 following TNT and surgery
Secondary outcomes (1)
- measure
- Good Pathological Response (TRG 0-1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Development of distant metastasis during TNT * Early disease progression * Missing radiological or pathological data * Incomplete or non-curative surgery
References
Publications (1)
- DERIVEDUyar 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. 2026 Mar;25(1):51-67.e7. doi: 10.1016/j.clcc.2025.10.002. Epub 2025 Oct 16. PMID 41198426