Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01694654 |
| Other study ID # |
SFT-1 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Phase 4
|
| First received |
September 24, 2012 |
| Last updated |
April 13, 2016 |
| Start date |
September 2012 |
| Est. completion date |
December 2016 |
Study information
| Verified date |
April 2016 |
| Source |
University of Zurich |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Switzerland: Swissmedic |
| Study type |
Observational
|
Clinical Trial Summary
1. To determine the incidence, prevalence and long-term outcome of patients with SFTP in
the German spoken part of Switzerland.
2. To define the role of immunohistochemical and molecular techniques, such as
immunostaining, FISH and mutational analysis regarding their ability to predict
malignant behavior in terms of prediction of overall survival and disease-free
survival.
Description:
Retrospective observational study on patients with SFPT in the German spoken part of
Switzerland between 2000 and 2011 (approximately 300 patients):
Phase 1) Information leaflet (letter of invitation) from study center (University Hospital
of Zurich) to the institutes for pathology from all university, cantonal and city hospitals
in the German spoken part of Switzerland. Patient recruitment performed by medical staff
from the aforementioned institutes for pathology.
Phase 2) Obtaining first orally (by telephone) and thereafter written informed consent from
the patients performed by medical staff from the aforementioned institutes for pathology.
Phase 3) After written and oral consent has been given, a doctoral candidate (member of the
study group, student of the University of Zurich) will perform the data entry based on
clinical and histological records locally at each external institute for pathology (no
patient record files will be copied or transferred in original to the University Hospital of
Zurich). Data entry in the electronic case report from (excel file on study laptop) will be
performed with anonymous data only. Hence, each patient will have a study number containing
the treating hospital, year of diagnosis and a consecutive number (e.g. KSSG-2011-1,
KSSG-2011-2, STZ-2007-1, STZ-2007-2, …). No names or birth dates will appear in the case
report form.
Provided that informed consent is given, patient follow-up will be performed by contacting
the primary care physician (general physician or family doctor) by telephone, which is
handled by the doctoral candidate.
Deceased patients will not be incorporated within the study.
Phase 4) Review of the histological specimen which are collected by the aforementioned
doctoral candidate and brought to the University Hospital of Zurich, Institute for
Pathology, where immunohistochemical/molecular examinations, such as immunostaining,
fluorescence in situ hybridization (FISH) and mutational analysis of the histological
specimen are performed by PD Dr. A. Soltermann, member of the study team. After this, the
specimens are returned to the original institute for pathology, where they were taken. All
specimens are made anonymous at the moment of collection at the external hospital by the
doctoral candidate (each specimen is labeled with the aforementioned study number, which is
assigned in the case report form).
Phase 5) Data analysis, publication.
