NCT02717936

Brief 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. The investigators therefore plan to include 73 participants with a confirmed diagnosis of desmoplastic squamous cell carcinoma and do regular follow up.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 25, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

January 27, 2016

Last Update Submit

March 24, 2016

Conditions

Squamous Cell Carcinoma of the Skin

Keywords

squamous cell carcinomadermatosurgeryimmunohistochemistry

Outcome Measures

Primary Outcomes (1)

  • Recurrence free survival of patients with desmoplastic squamous cell carcinoma (SCC) diagnosed with immunohistochemistry .

    4 years

Secondary Outcomes (4)

  • Reduction of local recurrence with immunohistochemistry

    4 years

  • Histological pattern of tumour growth (continuous versus discontinuous)

    4 years

  • Dimension of the tumor spreading according to histological work-up (measured in mm)

    4 years

  • Presence of perineurial and perivascular tumor invasion according to histological work-up

    4 years

Study Arms (1)

Immunohistochemistry

OTHER

Patients are investigated using immunohistochemistry with Pancytokeratin

Procedure: Immunohistochemistry using Pancytokeratin Staining

Interventions

Immunohistochemistry using Pancytokeratin StainingPROCEDURE
Immunohistochemistry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • desmoplastic squamous cell carcinoma (SCC) of the skin

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universityhospital

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2016

First Posted

March 24, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2020

Last Updated

March 25, 2016

Record last verified: 2016-01

Locations

DE(1)