NCT05316103 Targeted Optical Biopsy for Local Rectal Scars in Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy
| NCT ID | NCT05316103 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2021-11-04 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2021-11-04 with a primary completion date of 2026-11-01.
⚠ 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
Currently, low concordance (36%) is found between clinical complete response and pathologic complete response in patients with rectal cancer after neoadjuvant chemoradiotherapy. Probe-based confocal laser endoscopy (pCLE) provides a promising targeted optical biopsy to evaluate the response to neoadjuvant chemoradiotherapy. The aim of this study is to investigate whether pCLE-targeted optical biopsy can improve the accuracy of preoperative endoscopic biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy.
Eligibility Criteria
Inclusion Criteria: 1. Age from over 18 to under 80 years 2. American Society of Anesthesiology(ASA) score class I,II,or III 3. Locally advanced rectal cancer 4. Patient has completed standard neoadjuvant therapy 5. Expected surgical resection 6. Written informed consent Exclusion Criteria: 1. Pregnant or lactating women 2. Acute renal insufficiency or stage II to IV chronic renal insufficiency 3. Patients with allergic constitution
Contact & Investigator
Jun Yan, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Nanfang Hospital, Southern Medical University
Frequently Asked Questions
Who can join the NCT05316103 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, 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 NCT05316103 currently recruiting?
Yes, NCT05316103 is actively recruiting participants. Contact the research team at yanjunfudan@163.com for enrollment information.
Where is the NCT05316103 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05316103 clinical trial?
NCT05316103 is sponsored by Nanfang Hospital, Southern Medical University. The principal investigator is Jun Yan, M.D., Ph.D. at Nanfang Hospital, Southern Medical University. The trial plans to enroll 68 participants.
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