Locally Advanced Rectal Cancer (LARC)CINR-AINCT07049627
AI-Based Prediction of Pathological Response in Rectal Cancer Patients Receiving Total Neoadjuvant Therapy
An observational study of Locally Advanced Rectal Cancer (LARC), run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Locally Advanced Rectal Cancer (LARC)
- What is being tested?
- Total Neoadjuvant Therapy (TNT)
- How many people
- 93 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 5 Nov 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Development of distant metastasis during TNT
- Early disease progression
- Missing radiological or pathological data
- Incomplete or non-curative surgery
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Etlik City Hospital
Ankara, Yenimahalle, 06210
Etlik City Hospital
Ankara, YENİMAHALLE, 06210
About this study
Official title: Inflammatory, Nutritional, and Sarcopenia-Based Prediction of Pathological Response in Local Advanced Rectal Cancer: A Regression and AI Approach
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.
Read the detailed description
This is a retrospective observational study that evaluated 93 patients with locally advanced rectal cancer who received total neoadjuvant therapy (TNT) at Etlik City Hospital, Ankara, Turkey, between November 2022 and December 2024. The aim of the study was to investigate whether laboratory markers related to inflammation and nutrition, as well as changes in muscle mass (sarcopenia), could predict treatment response.
Patients who completed at least 12 weeks of chemotherapy and radiotherapy followed by curative surgery were included. Blood samples were used to calculate the C-reactive protein to albumin ratio (CAR) and the systemic immune-inflammation index (SII). Sarcopenia was assessed using contrast-enhanced CT images at the L3 vertebral level, obtained before and after treatment.
Based on these parameters, two composite scores-CINR-pCR and CINR-Ryan-were developed using multivariable logistic regression. The primary outcomes were pathological complete response (pCR) and favorable tumor regression grade (TRG 0-1). Predictive models were constructed using both conventional statistical methods and artificial intelligence (AI)-based algorithms, including Random Forest. Internal validation was performed via cross-validation, and model performance was assessed by area under the curve (AUC), sensitivity, and specificity.
All data used in this study were obtained from existing medical records as part of routine clinical care. No experimental treatments or additional interventions were administered. The results may contribute to optimizing personalized treatment strategies and clinical decision-making in rectal cancer.
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Being tested
- Total Neoadjuvant Therapy (TNT)
- Keywords
- Rectal Cancer, Total Neoadjuvant Therapy, Sarcopenia, Artificial Intelligence, Machine Learning
- Medical subject headings
- Rectal Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Total Neoadjuvant Therapy (TNT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
Proportion of patients achieving ypT0N0 following TNT and surgery
Measured: Within 16-24 weeks after TNT completion
Secondary outcomes (1)
Good Pathological Response (TRG 0-1)
Proportion of patients with Tumor Regression Grade 0-1 based on Ryan classification
Measured: Within 16-24 weeks after TNT completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start5 Nov 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Rectal Cancer (LARC)Studies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Galip Can Uyar, Ankara Etlik City Hospital
- Investigators
- Galip Can Uyar, MD, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049627
- Sponsor's protocol ID
- AEŞH-BADEK-2024-628
- Acronym
- CINR-AI
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Mar;25(1):51-67.e7. doi: 10.1016/j.clcc.2025.10.002. Epub 2025 Oct 16.
PubMed 41198426
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory, Nutritional, and Sarcopenia-Based Prediction of Pathological Response in Local Advanced Rectal Cancer: A Regression and AI Approach
- ClinicalTrials.gov ID
- NCT07049627
- Acronym / sponsor ID
- CINR-AI / AEŞH-BADEK-2024-628
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Keywords
- Rectal Cancer, Total Neoadjuvant Therapy, Sarcopenia, Artificial Intelligence, Machine Learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 5 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a retrospective observational study that evaluated 93 patients with locally advanced rectal cancer who received total neoadjuvant therapy (TNT) at Etlik City Hospital, Ankara, Turkey, between November 2022 and December 2024. The aim of the study was to investigate whether laboratory markers related to inflammation and nutrition, as well as changes in muscle mass (sarcopenia), could predict treatment response.
Patients who completed at least 12 weeks of chemotherapy and radiotherapy followed by curative surgery were included. Blood samples were used to calculate the C-reactive protein to albumin ratio (CAR) and the systemic immune-inflammation index (SII). Sarcopenia was assessed using contrast-enhanced CT images at the L3 vertebral level, obtained before and after treatment.
Based on these parameters, two composite scores-CINR-pCR and CINR-Ryan-were developed using multivariable logistic regression. The primary outcomes were pathological complete response (pCR) and favorable tumor regression grade (TRG 0-1). Predictive models were constructed using both conventional statistical methods and artificial intelligence (AI)-based algorithms, including Random Forest. Internal validation was performed via cross-validation, and model performance was assessed by area under the curve (AUC), sensitivity, and specificity.
All data used in this study were obtained from existing medical records as part of routine clinical care. No experimental treatments or additional interventions were administered. The results may contribute to optimizing personalized treatment strategies and clinical decision-making in rectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Locally Advanced Rectal Cancer Treated with TNT | – | Other: Total Neoadjuvant Therapy (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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- Development of distant metastasis during TNT
- Early disease progression
- Missing radiological or pathological data
- Incomplete or non-curative surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Neoadjuvant Therapy (TNT)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. | Other | Patients with Locally Advanced Rectal Cancer Treated with TNT |
Primary outcome
Pathological Complete Response (pCR)
Time frame: Within 16-24 weeks after TNT completion
Proportion of patients achieving ypT0N0 following TNT and surgery
1 secondary outcome
Good Pathological Response (TRG 0-1)
Time frame: Within 16-24 weeks after TNT completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Derived from this study: PubMed 41198426Uyar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galip Can Uyar, MD principal investigator
Ankara Etlik City Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Rectal Cancer (LARC), run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: Within 16-24 weeks after TNT completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07049627, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.