Metastases of Cutaneous Squamous Cell Carcinoma in Organ... | NCT01976468

Studies
Metastases of Cutaneous Squamous Cell Carcinoma in Organ Transplant Recipients. The "SCOPE-ITSCC Metastases Study"

NCT01976468

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Jul 29, 2019Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Squamous Cell Carcinoma

Interventions

SCC metastasis

Countries

Netherlands
Switzerland

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

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013Actual

Primary Completion Date

Jan 2023Estimated

Completion Date

Jan 2025Estimated

First Submitted Date

Oct 29, 2013

First Submission Date that Met QC Criteria

Nov 4, 2013

First Posted Date

Nov 5, 2013Estimated

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

Jul 25, 2019

Last Update Posted Date

Jul 29, 2019Actual

Name	Class
Leiden University Medical Center	OTHER

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

The investigators hypothesize that a low number of SCC in OTR will metastasize.

Detailed Description

In a large international multicenter prospective observational study a total number of 1000 OTR (organ transplant recipients) with a histologically proven cutaneous SCC (squamous cell carcinoma) will be included in 10 centers and followed during 2 years to establish the cumulative incidence of metastases in OTR with cutaneous SCC.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SCC metastasis		organ transplant recipients	Other: SCC metastasis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SCC metastasis	Other	occurrence of SCC metastasis	SCC metastasis

Measure	Description	Time Frame
SCC metastasis detection		two years

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Organ-transplant recipients (OTR).
Histologically proven cutaneous invasive SCC at time of inclusion

Exclusion criteria:

Lack of consent.
History of metastases of cutaneous SCC

Accepts Healthy Volunteers

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

organ transplant recipients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Günther Hofbauer, Prof MD	University Hospital Zurich, Division of Dermatology	Principal Investigator
Jan Nico Bouwes Bavinck	Leiden University Medical Center	Study Chair
Roel Genders, MD	Leiden University Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leiden University Medical Center		Leiden			Netherlands
University Hospital Zurich, Division of Dermatology

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