Squamous Cell Carcinoma of the SkinDesmoPEKNCT02717936
Investigation of Desmoplastic Squamous Cell Carcinoma
A study testing Immunohistochemistry using Pancytokeratin Staining in people with Squamous Cell Carcinoma of the Skin, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Aim of the study is to verify wether it is possible to have a more sensitive diagnostic tool using pancytokeratin immunohistochemistry for desmoplastic squamous cell carcinoma compared to regular H\&E staining. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Squamous Cell Carcinoma of the Skin
- What is being tested?
- Immunohistochemistry using Pancytokeratin Staining
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to Jan 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- desmoplastic squamous cell carcinoma (SCC) of the skin
Who cannot join
- tumor recurrence
- collision tumors
- other skin malignancies
- progeria
- Rothmund-Thomson-Syndrome
- lacking of the capacity for informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universityhospital
Tübingen, Baden-Wurttemberg, 72076
Lukas Kofler, MD, 07071/29-84555, lukas.kofler@med.uni-tuebingen.de
Hans-Martin Häfner, Prof, MD, 07071/29-84555, hansmartin.haefner@med.uni-tuebingen.de
About this study
Official title: Prospektive Therapie-Studie Zur Behandlung Des Desmoplastischen Plattenepithelkarzinoms
Aim of the study is to verify wether it is possible to have a more sensitive diagnostic tool using pancytokeratin immunohistochemistry for desmoplastic squamous cell carcinoma compared to regular H\&E staining. The investigators therefore plan to include 73 participants with a confirmed diagnosis of desmoplastic squamous cell carcinoma and do regular follow up.
- Conditions
- Squamous Cell Carcinoma of the Skin
- Being tested
- Immunohistochemistry using Pancytokeratin Staining
- Keywords
- squamous cell carcinoma, dermatosurgery, immunohistochemistry
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemistry using Pancytokeratin StainingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Immunohistochemistry | Other | Patients are investigated using immunohistochemistry with Pancytokeratin Receives: Procedure: Immunohistochemistry using Pancytokeratin Staining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival of patients with desmoplastic squamous cell carcinoma (SCC) diagnosed with immunohistochemistry .
Measured: 4 years
Secondary outcomes (4)
Reduction of local recurrence with immunohistochemistry
Measured: 4 years
Histological pattern of tumour growth (continuous versus discontinuous)
Measured: 4 years
Dimension of the tumor spreading according to histological work-up (measured in mm)
Measured: 4 years
Presence of perineurial and perivascular tumor invasion according to histological work-up
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the SkinStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717936
- Sponsor's protocol ID
- DESMOPEK1
- Acronym
- DesmoPEK
- Status last verified
- Jan 2016
- First submitted
- 27 Jan 2016
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospektive Therapie-Studie Zur Behandlung Des Desmoplastischen Plattenepithelkarzinoms
- ClinicalTrials.gov ID
- NCT02717936
- Acronym / sponsor ID
- DesmoPEK / DESMOPEK1
- Conditions
- Squamous Cell Carcinoma of the Skin
- Keywords
- squamous cell carcinoma, dermatosurgery, immunohistochemistry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 24 Mar 2016 (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.
Aim of the study is to verify wether it is possible to have a more sensitive diagnostic tool using pancytokeratin immunohistochemistry for desmoplastic squamous cell carcinoma compared to regular H\&E staining. The investigators therefore plan to include 73 participants with a confirmed diagnosis of desmoplastic squamous cell carcinoma and do regular follow up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunohistochemistry | Other | Procedure: Immunohistochemistry using Pancytokeratin StainingPatients are investigated using immunohistochemistry with Pancytokeratin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- desmoplastic squamous cell carcinoma (SCC) of the skin
Key exclusion criteria (6 listed)
- tumor recurrence
- collision tumors
- other skin malignancies
- progeria
- Rothmund-Thomson-Syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunohistochemistry using Pancytokeratin Staining | Procedure or surgery | Immunohistochemistry |
Primary outcome
Recurrence free survival of patients with desmoplastic squamous cell carcinoma (SCC) diagnosed with immunohistochemistry .
Time frame: 4 years
4 secondary outcomes
Reduction of local recurrence with immunohistochemistry
Time frame: 4 years
Histological pattern of tumour growth (continuous versus discontinuous)
Time frame: 4 years
Dimension of the tumor spreading according to histological work-up (measured in mm)
Time frame: 4 years
Presence of perineurial and perivascular tumor invasion according to histological work-up
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunohistochemistry using Pancytokeratin Staining in people with Squamous Cell Carcinoma of the Skin, run by University Hospital Tuebingen at 1 site in Germany.
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 6 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: status not confirmed, as of the sponsor's last update on 25 Mar 2016. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence free survival of patients with desmoplastic squamous cell carcinoma (SCC) diagnosed with immunohistochemistry . (time frame: 4 years). 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 25 Mar 2016.