ALDH2 Mutation in Taiwanese Head and Neck Cancer

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02761408

Enrollment

120

Registered

2016-05-04

Start date

2016-04-30

Completion date

2018-07-31

Last updated

2016-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatitis, Mucositis

Keywords

Head and neck cancer, Asian, ALDH2

Brief 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

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with treatment-related adverse events assessed by CTCAEv5.0	6 months after the end of the study	The side effects of each participant will be recorded accoiding to CTCAEv5.0 during the whole course of chemoradiation, by indicated physicians regularly

Countries

Taiwan

Contacts

Primary ContactLing-Wei Wang, MD

lwwang@vghtpe.gov.tw+886 2 28757270

Outcome results