NCT07049627Completed
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 · Last updated 8 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 93 (actual)
- First submitted
- 16 Jun 2025
- Start date
- 5 Nov 2022
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Ankara Etlik City Hospital
- Diseases
- Colorectal cancer, Childhood cancers
- NCT number
- NCT07049627
What you commit to
- Study type: Observational
- Participants enrolled: 93
- From 5 Nov 2022 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Incomplete or non-curative surgery
Other illness
- Early disease progression
Other
- Development of distant metastasis during TNT
- Missing radiological or pathological data
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Etlik City Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
Related publications
- 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 · PMID 41198426
This page is information, not medical advice. Discuss any trial with your doctor.