NCT02095912

Brief Summary

To identify risk factors for aggressiveness in Squamous Cell Carcinoma of the skin in organ transplant recipients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

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

February 18, 2014

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

1.7 years

First QC Date

February 18, 2014

Last Update Submit

August 9, 2016

Conditions

Squamous Cell Carcinoma

Keywords

Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Diameter of Squamous Cell Carcinoma

    * Location * exact size in mm * histological classification (well-differentiated, moderately-differentiated, poorly differentiated, spindle cell morphology, desmoplastic, basi-squamous, acantholytic) * Invasion * rapid growth * local recurrence * sentinel node sampling * Metastasis

    1 year

Secondary Outcomes (1)

  • Sun exposure history

    1 year

Other Outcomes (1)

  • Transplantation history

    1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Organ Transplant Recipients with: * \> 9 Squamous Cell Carcinoma (SCC) in total or * \> 2 SCC per year (in any one year) or * any single "index" SCC that has a very poorly differentiated cell morphology or that behaved aggressively in Terms of local recurrence or local/systemic metastasis

You may qualify if:

  • Organ transplant recipients with:
  • \> 9 SCC in total or
  • \> 2 SCC per year (in any one year) or
  • any single "index" SCC that has a very poorly differentiated cell morphology or that behaved aggressively in Terms of local recurrence or local/systemic metastasis

You may not qualify if:

  • Non organ transplant recipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsspital Zürich

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

  • Guenther Hofbauer, Prof MD

    University Hospital Zurich, Division of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 18, 2014

First Posted

March 26, 2014

Study Start

March 1, 2014

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

August 10, 2016

Record last verified: 2016-08

Locations

CH(1)