Microscopy Imaging of Whole-mount Stained Human Tissues

NCT05689112 | Unknown

• 1 other identifier: 202211038RINA
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumor, Brain; Tumor, Breast; Tumor Skin

Keywords

intraoperative assessment; whole-mount H&E staining; surgical border assessment

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Anticpated the study population of tumor assessment: 1. Skin cancer : 50. 2. Brain tumor : 50. 3. Breast cancer : 100.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Dermatology, National Taiwan University Hospital and College of Medicine, National Taiwan University

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Breast Neoplasms; Skin Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yi-Hua YH Liao, PhD

CONTACT

+886-23123456; yihualiao@ntu.edu.tw

Yao-Chen YC Tseng, Master

CONTACT

+886-33661552; opiuy1234567@yahoo.com.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: January 10, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-01

Locations

TW (1)