NCT03145506

Brief Summary

Freshly excised or freshly frozen tissue for Raman analysis will be obtained from a dermatology practice affiliated with UMCB. In the course of the routine removal of benign or malignant tumors in the office, skin cancer surgeons routinely check frozen sections to ensure adequate margins are obtained. Consent will be obtained from patients to provide freshly excised or freshly frozen leftover tissue obtained during Mohs surgery to be discarded after histological diagnosis. Freshly excised tissue will be measured at the time of excision before processing, while the freshly frozen tissue samples will be stored in a freezer at the Mohs clinic and transferred to the UT- Austin campus for spectroscopic analysis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 16, 2018

Status Verified

April 1, 2018

Enrollment Period

1 month

First QC Date

April 24, 2017

Last Update Submit

August 15, 2018

Conditions

Skin Cancer

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of spectroscopic device

    comparison of spectroscopic data to frozen section pathology used in Mohs surgery

    1 year

Study Arms (1)

Mohs Surgery Patients

Adult patients undergoing Mohs surgery for treatment of BCC or SCC

Device: Multimodal Spectroscopy

Interventions

Multimodal SpectroscopyDEVICE

optical measurement of excised tissue

Mohs Surgery Patients

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing treatment for SCC or BCC in local Mohs surgery clinic

You may qualify if:

  • All individuals over 18 undergoing Mohs surgery for treatment of BCC or SCC

You may not qualify if:

  • Under 18 years old, not undergoing Mohs surgery for treatment of BCC or SCC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jason Reichenberg, MD

    Seton Healthcare Family

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2017

First Posted

May 9, 2017

Study Start

November 1, 2016

Primary Completion

December 1, 2016

Study Completion

July 1, 2018

Last Updated

August 16, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share