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

NCT07346729 | Completed

• 1 other identifier: NFEC-2023-219
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Cancer

Keywords

Locally advanced rectal cancer; Neoadjuvant chemoradiotherapy; Metagenomic; Multi-kingdom analysis; Microbiota metabolism; Prediction model

Outcome Measures

Primary Outcomes (1)

• Tumor Pathological Response Grading (TRG Grading)

  Tumor Pathological Response Grading (TRG Grading) of Patients after Neoadjuvant Radiotherapy and Chemotherapy

  an average of 3 months after neoadjuvant radiotherapy and chemotherapy

Secondary Outcomes (2)

• Pathological Complete Response Rate (pCR)

  an average of 3 months after neoadjuvant radiotherapy and chemotherapy

• Clinical Complete Response Rate (cCR)

  an average of 3 months after neoadjuvant radiotherapy and chemotherapy

Study Arms (2)

responder

good response to neoadjuvant chemoradiotherapy

non-responders

bad response to neoadjuvant chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Locally Advanced Rectal Cancer

You may qualify if:

• 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

You may not qualify if:

• Previously received anti-tumor treatment
• History of other malignant tumors
• Imaging confirms the presence of distant metastases
• Patients with MSI-H or dMMR rectal cancer detected by immunohistochemistry or genetic testing
• Used probiotics, antibiotics, prebiotics, immunosuppressants, and glucocorticoids within the 4 weeks
• Pathological tissue specimens without assessable efficacy of neoadjuvant therapy
• Change treatment plan due to disease progression or severe treatment side effects
• According to the researcher's judgment, it is not suitable to participate in this study

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hosptial

Guangzhou, Guangdong, 510515, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and fecal samples

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 16, 2026
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)