Basal Cell CarcinomaNCT01540695
Does Cryofixation of Skin Specimens Affect Quality of Subsequent Formalin Fixed Paraffin Embedded H and E Histology
An observational study of Basal Cell Carcinoma and Squamous Cell Carcinoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
This prospective study of 60 slides of basal and squamous cell carcinomas of the skin aims to determine whether: 1. The process of cryofixation prior to generating formalin fixed paraffin embedded (FFPE) H\&E sections alters the histology in skin tumor specimens. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma, Squamous Cell Carcinoma
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jan 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients will be recruited from the Mohs unit of the HUP Department of Dermatology
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramsonc Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Does Cryofixation of Skin Specimens Affect Quality of Subsequent Formalin Fixed Paraffin Embedded H&E Histology
This prospective study of 60 slides of basal and squamous cell carcinomas of the skin aims to determine whether:
- The process of cryofixation prior to generating formalin fixed paraffin embedded (FFPE) H\&E sections alters the histology in skin tumor specimens.
- 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.
Read the detailed description
Generating formalin fixed paraffin embedded (FFPE) hematoxylin and eosin (H\&E) stained permanent sections from previously cryofixed tissue is a common practice used to confirm diagnosis of frozen section histology. In dermatology, this practice can be used to examine Mohs layers and its debulk as well as routine nonmelanoma skin cancer (NMSC) biopsies after initial histologic diagnosis with frozen sections. Even though freezing tissue can introduce histologic artifacts, there have been no studies documenting whether this occurs specifically in cryofixed tissues that are subsequently thawed for permanent FFPE H\&E histology. The purpose of our study is to determine whether the freeze-thaw process used to generate permanent sections after cryofixation introduces significantly detectable histologic differences compared to permanent sections that were not previously cryofixed. Thirty debulk specimens of basal cell and squamous cell carcinomas will be prospectively collected. Each specimen will be split so that half is processed as cryofixed permanents and the other half as noncryofixed permanents. The investigator will show each slide in random order to a group of four blinded participants (two dermatopathologists and two Mohs surgeons). Each participant must first rate the overall quality of histology. Then, each participant will rate each slide on the quality of cellular morphology, nuclear morphology, color and contrast of stains, intactness of specimen, and other miscellaneous artifacts. These data will then be analyzed for statistical significance.
- 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
- Medical subject headings
- Carcinoma, Basal Cell, Carcinoma, Squamous Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: October 2016 to March 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Miller, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540695
- Sponsor's protocol ID
- UPCC 25911
- Status last verified
- Jul 2019
- First submitted
- 9 Feb 2012
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Cryofixation of Skin Specimens Affect Quality of Subsequent Formalin Fixed Paraffin Embedded H&E Histology
- ClinicalTrials.gov ID
- NCT01540695
- Acronym / sponsor ID
- UPCC 25911
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 29 Feb 2012 (estimated)
- 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.
This prospective study of 60 slides of basal and squamous cell carcinomas of the skin aims to determine whether:
- The process of cryofixation prior to generating formalin fixed paraffin embedded (FFPE) H\&E sections alters the histology in skin tumor specimens.
- 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.
Detailed description
Generating formalin fixed paraffin embedded (FFPE) hematoxylin and eosin (H\&E) stained permanent sections from previously cryofixed tissue is a common practice used to confirm diagnosis of frozen section histology. In dermatology, this practice can be used to examine Mohs layers and its debulk as well as routine nonmelanoma skin cancer (NMSC) biopsies after initial histologic diagnosis with frozen sections. Even though freezing tissue can introduce histologic artifacts, there have been no studies documenting whether this occurs specifically in cryofixed tissues that are subsequently thawed for permanent FFPE H\&E histology. The purpose of our study is to determine whether the freeze-thaw process used to generate permanent sections after cryofixation introduces significantly detectable histologic differences compared to permanent sections that were not previously cryofixed. Thirty debulk specimens of basal cell and squamous cell carcinomas will be prospectively collected. Each specimen will be split so that half is processed as cryofixed permanents and the other half as noncryofixed permanents. The investigator will show each slide in random order to a group of four blinded participants (two dermatopathologists and two Mohs surgeons). Each participant must first rate the overall quality of histology. Then, each participant will rate each slide on the quality of cellular morphology, nuclear morphology, color and contrast of stains, intactness of specimen, and other miscellaneous artifacts. These data will then be analyzed for statistical significance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients will be recruited from the Mohs unit of the HUP Department of Dermatology
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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
Number of Adverse Events
Time frame: October 2016 to March 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
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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.
Christopher Miller, MD principal investigator
Abramson Cancer Center at Penn Medicine
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 Basal Cell Carcinoma and Squamous Cell Carcinoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Jul 2019. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: October 2016 to March 2018). 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 31 Jul 2019.