NCT01976468

Brief Summary

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

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

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

First Submitted

Initial submission to the registry

October 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2013

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

July 29, 2019

Status Verified

July 1, 2019

Enrollment Period

9.2 years

First QC Date

October 29, 2013

Last Update Submit

July 25, 2019

Conditions

Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • SCC metastasis detection

    two years

Study Arms (1)

SCC metastasis

organ transplant recipients

Other: SCC metastasis

Interventions

SCC metastasisOTHER

occurrence of SCC metastasis

SCC metastasis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

organ transplant recipients

You may qualify if:

  • Organ-transplant recipients (OTR).

You may not qualify if:

  • Lack of consent.
  • History of metastases of cutaneous SCC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Leiden University Medical Center

Leiden, Netherlands

Location

University Hospital Zurich, Division of Dermatology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2013

First Posted

November 5, 2013

Study Start

November 1, 2013

Primary Completion

January 1, 2023

Study Completion

January 1, 2025

Last Updated

July 29, 2019

Record last verified: 2019-07

Locations

NL(1)CH(1)