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

NCT ID: NCT01976468

Last Updated: 2019-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2025-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Squamous Cell Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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SCC metastasis

organ transplant recipients

SCC metastasis

Intervention Type OTHER

occurrence of SCC metastasis

Interventions

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SCC metastasis

occurrence of SCC metastasis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Günther Hofbauer, Prof MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Dermatology

Jan Nico Bouwes Bavinck

Role: STUDY_CHAIR

Leiden University Medical Center

Roel Genders, MD

Role: STUDY_DIRECTOR

Leiden University Medical Center

Locations

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Leiden University Medical Center

Leiden, , Netherlands

Site Status

University Hospital Zurich, Division of Dermatology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Netherlands Switzerland

Other Identifiers

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SCOPE-ITSCC metastases

Identifier Type: -

Identifier Source: org_study_id

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