Does Cryofixation of Skin Specimens Affect Quality of Subsequent Formalin Fixed Paraffin Embedded H and E Histology

NCT01540695 | Completed DMC

• 1 other identifier: UPCC 25911
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study of 60 slides of basal and squamous cell carcinomas of the skin aims to determine whether:

1. 1.The process of cryofixation prior to generating formalin fixed paraffin embedded (FFPE) H\&E sections alters the histology in skin tumor specimens.
2. 2.Which specific histologic parameters are altered between previously cryofixed versus routine FFPE sections. Histologic observations will be recorded by two dermatopathologists and two Mohs surgeons and statistically analyzed.

Conditions

Basal Cell Carcinoma; Squamous Cell Carcinoma

Keywords

Any patient with a routine basal cell or squamous cell carcinoma; of the skin diagnosed on frozen histology during a Mohs procedure

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  October 2016 to March 2018

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients will be recruited from the Mohs unit of the HUP Department of Dermatology

You may qualify if:

• Adult patients (age 18 or over) with a biopsy proven routine basal cell or squamous cell carcinoma of the skin who are scheduled for treatment with the Mohs procedure by Dr. Christopher Miller at the University of Pennsylvania's Division of Dermatologic Surgery will be included. Both female and male patients will be included.

You may not qualify if:

• Patients with basal cell or squamous cell carcinomas of more complex histopathology will be excluded from the study. Complex histopathology of a tumor is defined as features with aggressive, moderately to poorly differentiated, or unusual histopathology.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramsonc Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neoplasms, Squamous Cell

Study Officials

• Christopher Miller, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: February 29, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 31, 2019

Record last verified: 2019-07

Locations

US (1)