Rectal NeoplasmsNCT07419516
MRA Diameter as a Predictor for LLN Metastasis in Rectal Cancer.
An observational study of Rectal Neoplasms, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
This study aims to identify risk factors-including clinical and imaging indicators such as middle rectal artery (MRA) diameter-that may be associated with lateral lymph node metastasis (LLNM) in rectal cancer located below the peritoneal reflection, and to construct a corresponding predictive model.The main questions… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Neoplasms
- How many people
- 690 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Sep 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective cohort study included adult patients (aged 18-75 years) with pathologically confirmed rectal adenocarcinoma located below the peritoneal reflection, who had complete preoperative pelvic MRI data and were treated at The First Affiliated Hospital of Fujian Medical University between 2022 and 2024. The study aimed to analyze this population to identify risk factors and develop a predictive model for clinically suspected lateral lymph node metastasis.
Who may be able to join
- Age at diagnosis between 18 and 75 years
- Pathological confirmation of rectal adenocarcinoma by endoscopic biopsy
- Imaging confirmation that the tumor was located below the peritoneal reflection
- Availability of rectal MRI scans providing detailed imaging of the pelvic region
- Received treatment at The First Affiliated Hospital of Fujian Medical University between January 2022 and December 2024
Who cannot join
- Pathological diagnosis of non-primary rectal malignancies
- Previous treatment for rectal cancer with chemotherapy, radiotherapy, or surgery, with the current presentation indicating recurrence
- Incomplete rectal MRI data or poor image quality affecting interpretation
- Incomplete medical or clinical records. Ultimately, 690 patients were included in the final analysis
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350004
About this study
Official title: Middle Rectal Artery Diameter as a Predictor for Lateral Lymph Node Metastasis in Rectal Cancer: A Predictive Model for Surgical Decision-Making.
This study aims to identify risk factors-including clinical and imaging indicators such as middle rectal artery (MRA) diameter-that may be associated with lateral lymph node metastasis (LLNM) in rectal cancer located below the peritoneal reflection, and to construct a corresponding predictive model.The main questions it aims to answer are:
What factors are associated with clinically suspected lateral lymph node metastasis in rectal cancer below the peritoneal reflection? Can an effective predictive model be constructed based on these factors? Participants' clinical information has been collected for statistical analysis.
Read the detailed description
Objective: This study aimed to investigate the risk factors for suspected lateral lymph node metastasis in rectal cancer below the peritoneal reflection and to construct a predictive model.
Methods: This retrospective study analyzed data from 690 patients with rectal cancer below the peritoneal reflection who were treated at the First Affiliated Hospital of Fujian Medical University between January 2022 and December 2024. The original dataset was randomly divided into a training set and validation set at a ratio of 7:3. Univariate and multivariate logistic regression analyses were performed on the training set to identify the risk factors associated with clinical lateral lymph node (cLLN) metastasis and to construct a predictive model.
- Conditions
- Rectal Neoplasms
- Being tested
- No Intervention
- Keywords
- Rectal cancer, lateral lymph node metastasis, middle rectal artery diameter, predictive model
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a retrospective observational study. There is no intervention assigned as part of this research. The study involves the analysis of existing clinical data from patients who were clinically suspected of lateral lymph node metastasis (LLNM) versus those who were not. Treatments received by patients (e.g., surgery, radiotherapy) were part of their routine clinical care and are not interventions administered by this study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Clinically suspected LLNM | Patients with clinically suspected lateral lymph node metastasis. Receives: Other: No Intervention | |
| Clinically suspected non-LLNM | Patients without clinically suspected lateral lymph node metastasis. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Independent Risk Factors for Clinically Suspected Lateral Lymph Node Metastasis (cLLNM)
Multivariable logistic regression analysis incorporating preoperative clinical and imaging variables to identify independent risk factors associated with clinically suspected lateral lymph node metastasis (cLLNM). Results are presented as odds ratios with 95% confidence intervals.
Measured: At the time of preoperative assessment (Data collected retrospectively from January 2022 to December 2024).
Secondary outcomes (2)
Discriminative Ability for Clinically Suspected Lateral Lymph Node Metastasis Prediction
Assessment of the multivariable predictive model's discriminative performance in identifying patients with clinically suspected lateral lymph node metastasis (cLLNM). The model incorporates preoperative clinical and imaging variables, and its performance is quantified using the area under the receiver operating characteristic curve.
Measured: At the time of preoperative assessment (Data collected retrospectively from January 2022 to December 2024).
Diagnostic performance of the key predictor: middle rectal artery diameter
Sensitivity, specificity, accuracy, and optimal cutoff value (≥3.25 mm) of MRA diameter alone for identifying cLLNM.
Measured: At the time of preoperative assessment (Data collected retrospectively from January 2022 to December 2024).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Jan 2025
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe 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
- 690 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YongjianHuang, First Affiliated Hospital of Fujian Medical University
- Investigators
- Yongjian Huang, Principal investigator, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419516
- Sponsor's protocol ID
- 20251118020132592
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article, after deidentification, will be made available upon reasonable request to the corresponding author, after article publication.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle Rectal Artery Diameter as a Predictor for Lateral Lymph Node Metastasis in Rectal Cancer: A Predictive Model for Surgical Decision-Making.
- ClinicalTrials.gov ID
- NCT07419516
- Acronym / sponsor ID
- 20251118020132592
- Conditions
- Rectal Neoplasms
- Keywords
- Rectal cancer, lateral lymph node metastasis, middle rectal artery diameter, predictive model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 690 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 19 Feb 2026 (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 identify risk factors-including clinical and imaging indicators such as middle rectal artery (MRA) diameter-that may be associated with lateral lymph node metastasis (LLNM) in rectal cancer located below the peritoneal reflection, and to construct a corresponding predictive model.The main questions it aims to answer are:
What factors are associated with clinically suspected lateral lymph node metastasis in rectal cancer below the peritoneal reflection? Can an effective predictive model be constructed based on these factors? Participants' clinical information has been collected for statistical analysis.
Detailed description
Objective: This study aimed to investigate the risk factors for suspected lateral lymph node metastasis in rectal cancer below the peritoneal reflection and to construct a predictive model.
Methods: This retrospective study analyzed data from 690 patients with rectal cancer below the peritoneal reflection who were treated at the First Affiliated Hospital of Fujian Medical University between January 2022 and December 2024. The original dataset was randomly divided into a training set and validation set at a ratio of 7:3. Univariate and multivariate logistic regression analyses were performed on the training set to identify the risk factors associated with clinical lateral lymph node (cLLN) metastasis and to construct a predictive model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinically suspected LLNM | – | Other: No InterventionPatients with clinically suspected lateral lymph node metastasis. |
| Clinically suspected non-LLNM | – | Other: No InterventionPatients without clinically suspected lateral lymph node metastasis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective cohort study included adult patients (aged 18-75 years) with pathologically confirmed rectal adenocarcinoma located below the peritoneal reflection, who had complete preoperative pelvic MRI data and were treated at The First Affiliated Hospital of Fujian Medical University between 2022 and 2024. The study aimed to analyze this population to identify risk factors and develop a predictive model for clinically suspected lateral lymph node metastasis.
Key inclusion criteria (5 listed)
- Age at diagnosis between 18 and 75 years
- Pathological confirmation of rectal adenocarcinoma by endoscopic biopsy
- Imaging confirmation that the tumor was located below the peritoneal reflection
- Availability of rectal MRI scans providing detailed imaging of the pelvic region
- Received treatment at The First Affiliated Hospital of Fujian Medical University between January 2022 and December 2024
Key exclusion criteria (4 listed)
- Pathological diagnosis of non-primary rectal malignancies
- Previous treatment for rectal cancer with chemotherapy, radiotherapy, or surgery, with the current presentation indicating recurrence
- Incomplete rectal MRI data or poor image quality affecting interpretation
- Incomplete medical or clinical records. Ultimately, 690 patients were included in the final analysis
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 |
|---|---|---|
| No InterventionThis is a retrospective observational study. There is no intervention assigned as part of this research. The study involves the analysis of existing clinical data from patients who were clinically suspected of lateral lymph node metastasis (LLNM) versus those who were not. Treatments received by patients (e.g., surgery, radiotherapy) were part of their routine clinical care and are not interventions administered by this study protocol. | Other | Clinically suspected LLNM, Clinically suspected non-LLNM |
Primary outcome
Independent Risk Factors for Clinically Suspected Lateral Lymph Node Metastasis (cLLNM)
Time frame: At the time of preoperative assessment (Data collected retrospectively from January 2022 to December 2024).
Multivariable logistic regression analysis incorporating preoperative clinical and imaging variables to identify independent risk factors associated with clinically suspected lateral lymph node metastasis (cLLNM). Results are presented as odds ratios with 95% confidence intervals.
2 secondary outcomes
Discriminative Ability for Clinically Suspected Lateral Lymph Node Metastasis Prediction
Time frame: At the time of preoperative assessment (Data collected retrospectively from January 2022 to December 2024).
Diagnostic performance of the key predictor: middle rectal artery diameter
Time frame: At the time of preoperative assessment (Data collected retrospectively from January 2022 to December 2024).
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 19 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after deidentification, will be made available upon reasonable request to the corresponding author, after article publication.
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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.
Yongjian Huang principal investigator
First Affiliated Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Neoplasms, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
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 5 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 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Independent Risk Factors for Clinically Suspected Lateral Lymph Node Metastasis (cLLNM) (time frame: At the time of preoperative assessment (Data collected retrospectively from January 2022 to December 2024).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2026.