Investigation of Desmoplastic Squamous Cell Carcinoma | NCT02717936

Studies
Investigation of Desmoplastic Squamous Cell Carcinoma

NCT02717936

Sponsor

University Hospital Tuebingen

Status

Unknown status

Last Update Posted

Mar 25, 2016Estimated

Enrollment

73Estimated

Phase

Not Applicable

Conditions

Squamous Cell Carcinoma of the Skin

Interventions

Immunohistochemistry using Pancytokeratin Staining

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Jan 2018Estimated

Completion Date

Jan 2020Estimated

First Submitted Date

Jan 27, 2016

First Submission Date that Met QC Criteria

Mar 18, 2016

First Posted Date

Mar 24, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2016

Last Update Posted Date

Mar 25, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

73Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immunohistochemistry	Other	Patients are investigated using immunohistochemistry with Pancytokeratin	Procedure: Immunohistochemistry using Pancytokeratin Staining

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Immunohistochemistry using Pancytokeratin Staining	Procedure		Immunohistochemistry

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universityhospital	Recruiting	Tübingen	Baden-Wurttemberg	72076	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002294	Carcinoma, Squamous Cell

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided