ALDH2 Mutation in Taiwanese Head and Neck Cancer

NCT ID: NCT02761408

Last Updated: 2016-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-07-31

Brief Summary

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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

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* 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.

Conditions

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Dermatitis Mucositis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ling-Wei Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Center, Taipei Veterans General Hospital

Locations

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Cancer Center, Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ling-Wei Wang, MD

Role: CONTACT

+886 2 28757270 ext. 208

Other Identifiers

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2016-03-008AC

Identifier Type: -

Identifier Source: org_study_id

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