Skin Cancer, Benign Skin Tumor, Inflammatory Skin DiseaseNCT02891291
Optical Tomographic Scanner for Skin Lesions
An observational study of Skin Cancer, Benign Skin Tumor, Inflammatory Skin Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Optical coherence tomography is technology widely used in medicine. In this study, the investigators will use an optical tomographic scanner to scan skin tissue image. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Skin Cancer, Benign Skin Tumor, Inflammatory Skin Disease
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2016to May 2019
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient's age are between 20 to 100 years old. Patients who receive skin biopsy or surgery at Department of Dermatology, National Taiwan University Hospital, Taiwan.
Patient who receive skin biopsy or surgery due to skin cancers, benign skin diseases, or inflammatory skin diseases.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 10002
JENGWEI TJIU, MDPHD, 886-23123456 ext. 65315, jengweitjiu@gmail.com
About this study
Optical coherence tomography is technology widely used in medicine. In this study, the investigators will use an optical tomographic scanner to scan skin tissue image.
Read the detailed description
The investigators will use optical tomographic scanner to scan skin specimen and obtain tissue images. Part of skin specimen obtained from skin biopsy or surgery will be scanned.
- Keywords
- optical coherence tomography
- Medical subject headings
- Skin Neoplasms, Dermatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin tissue image obtained.
Part of the skin specimen from surgery or biopsy will be scanned.
Measured: 1 week
Secondary outcomes (1)
Skin histopathology
The skin specimen will be stained with hematoxylin and eosin. Histopathological pictures (or findings) will be obtained and correlate with the scanned images.
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Cancer, Benign Skin Tumor, Inflammatory Skin DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- JENGWEI TJIU, MDPHD, Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891291
- Sponsor's protocol ID
- 201604078RINB
- Status last verified
- Sep 2016
- First submitted
- 1 Sep 2016
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Tomographic Scanner for Skin Lesions
- ClinicalTrials.gov ID
- NCT02891291
- Acronym / sponsor ID
- 201604078RINB
- Keywords
- optical coherence tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- Jun 2016
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 7 Sep 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.
Optical coherence tomography is technology widely used in medicine. In this study, the investigators will use an optical tomographic scanner to scan skin tissue image.
Detailed description
The investigators will use optical tomographic scanner to scan skin specimen and obtain tissue images. Part of skin specimen obtained from skin biopsy or surgery will be scanned.
Study design
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient's age are between 20 to 100 years old. Patients who receive skin biopsy or surgery at Department of Dermatology, National Taiwan University Hospital, Taiwan.
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
Skin tissue image obtained.
Time frame: 1 week
Part of the skin specimen from surgery or biopsy will be scanned.
1 secondary outcome
Skin histopathology
Time frame: 2 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Individual participant dataSharing planned: No. No plan to share data.
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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.
JENGWEI TJIU, MDPHD principal investigator
NTUH
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 Skin Cancer, Benign Skin Tumor, Inflammatory Skin Disease, run by National Taiwan University Hospital 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?
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 21 Sep 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 JENGWEI TJIU (886-23123456 ext. 65315, jengweitjiu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin tissue image obtained. (time frame: 1 week). 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 21 Sep 2016.