ALDH2 Mutation in Taiwanese Head and Neck Cancer

Taipei Veterans General Hospital

Status: Unknown

Conditions: Dermatitis; Mucositis

Study type: Observational

Funder types: Other

Identifiers

NCT02761408

2016-03-008AC

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >20, <70
• Newly diagnosed head and neck squamous cell carcinoma
• Tissue proved
• Signed informed consent
• Suitable for chemoradiation

Exclusion criteria

• Uncontrolled underlying diseases
• Allergy to chemotherapy
• Uncontrolled skin diseases or mucosa diseases
• Previously radiation therapy over head and neck
• Combined with other cancer currently