Targeted Optical Biopsy for Local Rectal Scars in Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy

Recruiting now · Not applicable

Conditions studied: Rectal Cancer

In brief

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.

Key facts

Study ID

NCT05316103

Run by

Nanfang Hospital, Southern Medical University

People needed

68

Starts

2021-11-04

Expected to finish

2026-11-01

Last updated by the study team

2023-05-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age from over 18 to under 80 years
• American Society of Anesthesiology(ASA) score class I,II,or III
• Locally advanced rectal cancer
• Patient has completed standard neoadjuvant therapy
• Expected surgical resection
• Written informed consent

You may not qualify if…

• Pregnant or lactating women
• Acute renal insufficiency or stage II to IV chronic renal insufficiency
• Patients with allergic constitution

Where it is running

• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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