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Article History

Received: 10 June 2025

Accepted: 16 February 2026

First Online: 26 February 2026

Declarations

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: The investigator will ensure that this study is conducted in full conformity with the current revision of the Declaration of Helsinki (last amended October 2013). This trial has obtained ethical approval from the Institutional Review Board of The University of Hong Kong/Hospital Authority Hong Kong West Cluster HKU/HA HKW IRB (UW25-184, approved 7th May 2025). The trial has been registered at ClinicalTrials.gov ( ) with the identifier number NCT06147310. Study investigators at the coordinating centre (project management group) meet monthly to review trial progress, including recruitment, protocol adherence, data quality, and safety reports. The PI and data safety coordinator will lead quarterly internal audits of trial conduct, including case report form (CRF) completeness, informed consent documentation, and adverse event reporting, to ensure regulatory compliance, proper documentation, and adherence to Good Clinical Practice (GCP). Oversight is ensured through external representative involvement including data safety coordinator and clinical research centre representative for impartiality. HKU/HA HKW IRB has the authority to audit studies under their jurisdiction. Adverse events, concurrent procedures, and protocol deviations will be documented and addressed appropriately. Serious adverse events will be reported to the HKU/HA HKW IRB within 24 h of notification to the study investigators. Primary data will be stored and retrieved from the IAD-CRC. The participants will be identified by a study-specific participant number and/or code in the secondary database after retrieving data from the primary database for data analysis. CRF will be in written format with identifiers removed and assigned identifying codes. Codes will be stored in a secure location and separated from data. The name and any other identifying detail will not be included in any secondary study data electronic file. All documents will be stored securely and only accessible by trial staff and authorized personnel. All research-related records (personal and study data) will be retained for 5 years after study completion. Protocol amendment will be made notified to the funding body by the principal investigator and submitted the protocol amendment form with amended information provided through the Hospital Authority Clinical Research Ethics Review Portal. Upon approval, the revised protocol document will be added to each site’s Investigator Site File (ISF). To ensure compliance across sites, the PI will conduct amendment training sessions with investigators and confirm their acknowledgment of the changes immediately upon IRB approval. In addition, substantive protocol changes will be reflected in the clinical trial registry within 60 days of IRB approval. A standardized documentation system will be implemented to document protocol deviation. Major deviations will be reported to the IRB within 1 month of identification, while minor deviations will be reported within 3 months, and all instances will be recorded using a formal breach report form.

: Consent for publication from subject will be obtained during the informed consent form.

: The authors reported that there are no known competing interests.