Microscopy Imaging of Whole-mount Stained Human Tissues | NCT05689112

Studies
Microscopy Imaging of Whole-mount Stained Human Tissues

NCT05689112

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Aug 21, 2024Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Tumor, Brain
Tumor, Breast
Tumor Skin

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2023Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jan 9, 2023

First Submission Date that Met QC Criteria

Jan 9, 2023

First Posted Date

Jan 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2024

Last Update Posted Date

Aug 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are more than 20 years old.
Diagnosed as patients suffered by skin tumor, brain tumor and breast tumor.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Anticpated the study population of tumor assessment:

Skin cancer : 50.
Brain tumor : 50.
Breast cancer : 100.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yi-Hua YH Liao, PhD	Contact	+886-23123456	265317	yihualiao@ntu.edu.tw
Yao-Chen YC Tseng, Master	Contact	+886-33661552		opiuy1234567@yahoo.com.tw

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dermatology, National Taiwan University Hospital and College of Medicine, National Taiwan University	Recruiting	Taipei			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms
D001943	Breast Neoplasms
D012878	Skin Neoplasms

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided