NCT07566559 Rectal Cancer Neoadjuvant Therapy-Real World Study
| NCT ID | NCT07566559 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Friendship Hospital |
| Condition | Rectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 869 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 869 participants in total. It began in 2025-01-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to utilise a real-world data platform to integrate multi-omics data-including radiomics, gut microbiota, pathological quality control and liquid biopsy-to construct a multidimensional predictive model for the efficacy of rectal cancer treatment following neoadjuvant therapy. By integrating multimodal data, the study aims to accurately assess the efficacy of neoadjuvant therapy and identify patients suitable for a 'watch-and-wait' strategy, thereby achieving tumour control and preserving organ function without the need for surgery. Furthermore, it seeks to provide scientific evidence for the efficacy of the 'watch-and-wait' strategy and the selection of optimal timing for surgery, whilst validating the model's effectiveness and assessing its clinical feasibility through prospective clinical trials.
Eligibility Criteria
Inclusion Criteria: * The patient is informed and has provided written informed consent; * Rectal adenocarcinoma confirmed by colonoscopic biopsy and pathology, meeting the following criteria: 1. Clinical stage II/III locally advanced rectal cancer (LARC): cT1-4aN0-2M0; 2. The distal edge of the tumor is ≤ 10 cm from the anal verge (measured by MRI); 3. No distant metastasis; 4. Scheduled to receive neoadjuvant therapy; * Age ≥ 18 years, male or female。 Exclusion Criteria: * Presence of distant organ metastasis; * Multiple primary colorectal cancers; * History of prior malignancy (except completely cured carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07566559 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07566559 currently recruiting?
Yes, NCT07566559 is actively recruiting participants. Contact the research team at yaohongwei@ccmu.edu.cn for enrollment information.
Where is the NCT07566559 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07566559 clinical trial?
NCT07566559 is sponsored by Beijing Friendship Hospital. The trial plans to enroll 869 participants.
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