ALDH2 Mutation in Taiwanese Head and Neck Cancer

Mucositis Clinical Trial

Official title: Correlation Between Radiation Dermatitis/Mucositis and ALDH2 Mutation in Taiwanese Head and Neck Cancer

Status Recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the effect of ALDH2 mutation in radiation associating dermatitis or mucositis in head and neck cancer patients who accept chemoradiation therapy

Clinical Trial Description

• One-site audit. The enrolled subject is confirmed by PIs

◦◦Source data is compared to external data sources medical records, either paper or electronic case report forms.

• NCI CTCAE v5.0 for AE records

• Patient recruitment according to inclusion criteria: 1. Newly diagnosed locally head and neck squamous cell carcinoma; 2. Apply for primary chemoradiation or adjuvant chemoradiation; 3. Signed informed consent

• Sample size assessment: 60 subjects will be included in one year for total 120 subjects

• Missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results

• Fisher's exact test is for category comparison. Kaplan-Meier analysis is for survival analysis. AE grades will be analyzed according to NCI guideline. Two-side p < 0.05 is suggested significant. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dermatitis
• Eczema
• Head and Neck Neoplasms
• Mucositis

• NCT number: NCT02761408
• Study type: Observational
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Ling-Wei Wang, MD
• Phone: +886 2 28757270
• Email: lwwang@vghtpe.gov.tw
• Status: Recruiting
• Phase: N/A
• Start date: April 2016
• Completion date: July 2018