DermatitisNCT02761408
ALDH2 Mutation in Taiwanese Head and Neck Cancer
An observational study of Dermatitis and Mucositis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Dermatitis, Mucositis
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2016to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Locally advanced Taiwanese head and neck squamous cell carcinoma patients who intend to accept primary chemoradiation or surgery with adjuvant chemoradiation, without previous treatment
Who may be able to join
- Age >20, <70
- Newly diagnosed head and neck squamous cell carcinoma
- Tissue proved
- Signed informed consent
- Suitable for chemoradiation
Who cannot join
- Uncontrolled underlying diseases
- Allergy to chemotherapy
- Uncontrolled skin diseases or mucosa diseases
- Previously radiation therapy over head and neck
- Combined with other cancer currently
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Cancer Center, Taipei Veterans General Hospital
Taipei, 11217
Ling-Wei Wang, MD
About this study
Official title: Correlation Between Radiation Dermatitis/Mucositis and ALDH2 Mutation in Taiwanese Head and Neck Cancer
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
Read the 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.
- Conditions
- Dermatitis, Mucositis
- Keywords
- Head and neck cancer, Asian, ALDH2
- Medical subject headings
- Dermatitis, Mucositis, Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatitisStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ling-Wei Wang, MD, Principal investigator, Cancer Center, Taipei Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761408
- Sponsor's protocol ID
- 2016-03-008AC
- Status last verified
- Apr 2016
- First submitted
- 26 Apr 2016
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Radiation Dermatitis/Mucositis and ALDH2 Mutation in Taiwanese Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02761408
- Acronym / sponsor ID
- 2016-03-008AC
- Conditions
- Dermatitis, Mucositis
- Keywords
- Head and neck cancer, Asian, ALDH2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Locally advanced Taiwanese head and neck squamous cell carcinoma patients who intend to accept primary chemoradiation or surgery with adjuvant chemoradiation, without previous treatment
Key inclusion criteria (5 listed)
- Age >20, <70
- Newly diagnosed head and neck squamous cell carcinoma
- Tissue proved
- Signed informed consent
- Suitable for chemoradiation
Key exclusion criteria (5 listed)
- Uncontrolled underlying diseases
- Allergy to chemotherapy
- Uncontrolled skin diseases or mucosa diseases
- Previously radiation therapy over head and neck
- Combined with other cancer currently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with treatment-related adverse events assessed by CTCAEv5.0
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling-Wei Wang, MD principal investigator
Cancer Center, Taipei Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis and Mucositis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ling-Wei Wang, MD (+886 2 28757270 ext. 208, lwwang@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events assessed by CTCAEv5.0 (time frame: 6 months after the end of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016.