Investigation of Desmoplastic Squamous Cell Carcinoma (DesmoPEK)

March 24, 2016 updated by: University Hospital Tuebingen

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Tübingen, Baden-Württemberg, Germany, 72076
        • Recruiting
        • Universityhospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jürgen Bauer, Prof, MD
        • Sub-Investigator:
          • Gisela Metzler, MD
        • Sub-Investigator:
          • Franziska Eberle, PD, MD
        • Sub-Investigator:
          • Helmut Breuninger, Prof, MD
        • Sub-Investigator:
          • Ulrike Leiter, PD, MD
        • Sub-Investigator:
          • Claudia Schulz, MD
        • Sub-Investigator:
          • Markus Krug, MD
        • Principal Investigator:
          • Hans-Martin Häfner, Prof, MD
        • Sub-Investigator:
          • Lukas Kofler, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • desmoplastic squamous cell carcinoma (SCC) of the skin

Exclusion Criteria:

  • tumor recurrence
  • collision tumors
  • other skin malignancies
  • progeria
  • Rothmund-Thomson-Syndrome
  • lacking of the capacity for informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Immunohistochemistry
Patients are investigated using immunohistochemistry with Pancytokeratin
Procedure: Immunohistochemistry using Pancytokeratin Staining

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence free survival of patients with desmoplastic squamous cell carcinoma (SCC) diagnosed with immunohistochemistry .
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction of local recurrence with immunohistochemistry
Time Frame: 4 years
4 years
Histological pattern of tumour growth (continuous versus discontinuous)
Time Frame: 4 years
4 years
Dimension of the tumor spreading according to histological work-up (measured in mm)
Time Frame: 4 years
4 years
Presence of perineurial and perivascular tumor invasion according to histological work-up
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

March 18, 2016

First Posted (Estimate)

March 24, 2016

Study Record Updates

Last Update Posted (Estimate)

March 25, 2016

Last Update Submitted That Met QC Criteria

March 24, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DESMOPEK1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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