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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02761408
• Other study ID #: 2016-03-008AC
• Status: Recruiting
• Phase: N/A
• First received: April 26, 2016
• Last updated: May 2, 2016
• Start date: April 2016
• Est. completion date: July 2018

Study information

• Verified date: April 2016
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Ling-Wei Wang, MD
• Phone: +886 2 28757270
• Email: lwwang[@]vghtpe.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dermatitis
• Eczema
• Head and Neck Neoplasms
• Mucositis

Locations

Country	Name	City	State
Taiwan	Cancer Center, Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events assessed by CTCAEv5.0	The side effects of each participant will be recorded accoiding to CTCAEv5.0 during the whole course of chemoradiation, by indicated physicians regularly	6 months after the end of the study	No