Ignite Creation Date:
2024-05-06 @ 8:34 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02761408
Status:
UNKNOWN
Last Update Posted:
2016-05-04
First Post:
2016-04-26
Brief Title:
ALDH2 Mutation in Taiwanese Head and Neck Cancer
Sponsor:
Taipei Veterans General Hospital Taiwan
Organization:
Taipei Veterans General Hospital Taiwan
Study Overview
Official Title:
Correlation Between Radiation DermatitisMucositis and ALDH2 Mutation in Taiwanese Head and Neck Cancer
Status:
UNKNOWN
Status Verified Date:
2016-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 v50 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
Fishers 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 005 is suggested significant
Source data is compared to external data sources medical records either paper or electronic case report forms
NCI CTCAE v50 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
Fishers 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 005 is suggested significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None