Tumor, BrainNCT05689112
Microscopy Imaging of Whole-mount Stained Human Tissues
An observational study of Tumor, Brain and Tumor, Breast, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to develop an imaging platform for intraoperative tumor margin delineation in 250 cases of tumor-suffered patients. The main questions it aims to answer are: to develop the protocol of rapid assessment of surgical specimens without need for fixation, embedding, and cryosectioning… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tumor, Brain, Tumor, Breast, Tumor Skin
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jan 2023to 31 Dec 2025
- How long will I take part?
- 5 Years
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Anticpated the study population of tumor assessment: 1. Skin cancer : 50. 2. Brain tumor : 50. 3. Breast cancer : 100.
Who may be able to join
- Patients who are more than 20 years old.
- Diagnosed as patients suffered by skin tumor, brain tumor and breast tumor.
Who cannot join
- Patients who can't speak and communicate with others.
- Patients who can't make eventual and exact pathological assessment for his/her diseases.
- Patients who only can fit for slicing tumor.
- Removed tissues which obviously vary after severe ray radiation under microscopy observation.
- Diameter of tumors are under 1 centimeter.
- Breast carcinoma in situ.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Dermatology, National Taiwan University Hospital and College of Medicine, National Taiwan University
Taipei
Yi-Hua Liao, +886-23123456 ext. 263155, yihualiao@ntu.edu.tw
About this study
Official title: Microscopy Imaging of Whole-mount Stained Human Tissues: Development of an Imaging Platform for Intraoperative Tumor Margin Delineation
The goal of this clinical trial is to develop an imaging platform for intraoperative tumor margin delineation in 250 cases of tumor-suffered patients. The main questions it aims to answer are:
- to develop the protocol of rapid assessment of surgical specimens without need for fixation, embedding, and cryosectioning required for conventional histopathology.
Participants will provide a small piece of their surgical specimens from tumor removal surgery .
If there is a comparison group: Researchers will compare normal specimens to see if we can observe the difference.
- Conditions
- Tumor, Brain, Tumor, Breast, Tumor Skin
- Keywords
- intraoperative assessment, whole-mount H&E staining, surgical border assessment
- Medical subject headings
- Brain Neoplasms, Breast Neoplasms, Skin Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The assessment between tumor cases and control cases
Do comparison with images acquired by our microscopy (with the whole-mount staining method) and bright field microscopy (with standard FFPE method) and do assessment to interpret tumor characteristics
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start10 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor, BrainStudies 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689112
- Sponsor's protocol ID
- 202211038RINA
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microscopy Imaging of Whole-mount Stained Human Tissues: Development of an Imaging Platform for Intraoperative Tumor Margin Delineation
- ClinicalTrials.gov ID
- NCT05689112
- Acronym / sponsor ID
- 202211038RINA
- Conditions
- Tumor, Brain, Tumor, Breast, Tumor Skin
- Keywords
- intraoperative assessment, whole-mount H&E staining, surgical border assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Jan 2023 (actual)
- 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 goal of this clinical trial is to develop an imaging platform for intraoperative tumor margin delineation in 250 cases of tumor-suffered patients. The main questions it aims to answer are:
- to develop the protocol of rapid assessment of surgical specimens without need for fixation, embedding, and cryosectioning required for conventional histopathology.
Participants will provide a small piece of their surgical specimens from tumor removal surgery .
If there is a comparison group: Researchers will compare normal specimens to see if we can observe the difference.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Anticpated the study population of tumor assessment: 1. Skin cancer : 50. 2. Brain tumor : 50. 3. Breast cancer : 100.
Key inclusion criteria (2 listed)
- Patients who are more than 20 years old.
- Diagnosed as patients suffered by skin tumor, brain tumor and breast tumor.
Key exclusion criteria (6 listed)
- Patients who can't speak and communicate with others.
- Patients who can't make eventual and exact pathological assessment for his/her diseases.
- Patients who only can fit for slicing tumor.
- Removed tissues which obviously vary after severe ray radiation under microscopy observation.
- Diameter of tumors are under 1 centimeter.
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
The assessment between tumor cases and control cases
Time frame: 5 years
Do comparison with images acquired by our microscopy (with the whole-mount staining method) and bright field microscopy (with standard FFPE method) and do assessment to interpret tumor characteristics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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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.
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 Tumor, Brain and Tumor, Breast, 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?
The sponsor lists 2 inclusion and 6 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 21 Aug 2024. 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 Yi-Hua YH Liao, PhD (+886-23123456 ext. 265317, yihualiao@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The assessment between tumor cases and control cases (time frame: 5 years). 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 Aug 2024.