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NCT01976468 Clinical Trial

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

Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01976468
Other study ID # SCOPE-ITSCC metastases
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 2013
Est. completion date January 2025

Study information
Verified date July 2019
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date January 2025
Est. primary completion date January 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• SCC metastasis
occurrence of SCC metastasis

Locations
Country Name City State
Netherlands Leiden University Medical Center Leiden
Switzerland University Hospital Zurich, Division of Dermatology Zurich ZH

Sponsors (2)
Lead Sponsor Collaborator
University of Zurich Leiden University Medical Center

Countries where clinical trial is conducted

Netherlands,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary SCC metastasis detection two years
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