NCT07346729Completed
Exploring the Predictive Effect of Intestinal and Oral Microbiota on the Efficacy of Neoadjuvant Radiotherapy and Chemotherapy for Locally Advanced Rectal Cancer Based on Machine Learning
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
This study is a one-year, observational, prospective cohort study. For enrolled patients with newly diagnosed locally advanced rectal cancer, the treatment plan will be decided by the physician based on the 2022 NCCN Rectal Cancer Clinical Practice Guidelines in combination with the hospital's protocols. The researchers will review the patient's medical history and laboratory reports, along with imaging examinations, to determine the patient's eligibility based on the inclusion and exclusion criteria. Before data collection, patients must sign the most recent IRB/IEC-approved informed consent form (ICF). After being diagnosed with locally advanced MSS rectal cancer, patients will provide stool and saliva samples upon admission before receiving treatment. Metagenomic sequencing will be performed to determine the abundance of gut and oral microbiota. Using these data, a predictive model will be established using machine learning methods to predict the TRG (Tumor Regression Grade) after neoadjuvant chemoradiotherapy in the enrolled patients, with internal validation conducted.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 60 (actual)
- First submitted
- 8 Jan 2026
- Start date
- 1 Jun 2023
- Primary completion date
- 1 Jun 2024
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Colorectal cancer
- NCT number
- NCT07346729
What you commit to
- Study type: Observational
- Participants enrolled: 60
- From 1 Jun 2023 to the primary completion date, 1 Jun 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
- Previously received anti-tumor treatment
- Pathological tissue specimens without assessable efficacy of neoadjuvant therapy
Other illness
- History of other malignant tumors
- Patients with MSI-H or dMMR rectal cancer detected by immunohistochemistry or genetic testing
- Change treatment plan due to disease progression or severe treatment side effects
Other
- Imaging confirms the presence of distant metastases
- Used probiotics, antibiotics, prebiotics, immunosuppressants, and glucocorticoids within the 4 weeks
- According to the researcher's judgment, it is not suitable to participate in this study
Who the study is looking for
- Voluntary signing of informed consent form
- Age range: 18-75 years old
- Diagnosed by histopathological examination and indicated by comprehensive evaluation for neoadjuvant radiotherapy and chemotherapy in locally advanced rectal cancer patients
- Immunohistochemistry or genetic testing for MSS
- Imaging shows no distant metastatic lesions
- ECOG score 0-1
- All patients are required to complete neoadjuvant concurrent chemoradiotherapy and intraoperative chemotherapy at our center, and return to the hospital on schedule for preoperative evaluation and tumor resection surgery
- After inspection and evaluation, there is normal bone marrow hematopoiesis, liver and kidney function
Age in the registry: 18 years to 75 years · 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 |
|---|---|---|---|
| Nanfang Hosptial Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
Related publications
- Oral and gut microbiota profiles in patients with locally advanced rectal cancer with varying responses to neoadjuvant chemoradiotherapy.Funct Integr Genomics · 2026 · PMID 42690486
This page is information, not medical advice. Discuss any trial with your doctor.