Epidemiology and Outcome of Solitary Fibrous Tumors of the Pleura.

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01694654
First received: September 24, 2012
Last updated: September 26, 2012
Last verified: September 2012
  Purpose
  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.

Condition Phase
Solitary Fibrous Tumors of the Pleura
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Epidemiology and Outcome of Solitary Fibrous Tumors of the Pleura. A Multicenter Study.

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Biospecimen Retention:   Samples With DNA

Tumor specimen (operative resectate)


Estimated Enrollment: 300
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Histologically proven diagnosis of SFTP between 2000 and 2011.

Criteria

Inclusion criteria:

  • Histologically proven diagnosis of SFTP between 2000 and 2011.

Exclusion criteria:

  • Missing informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694654

Contacts
Contact: Daniel Franzen, MD daniel.franzen@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Internal Medicine Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Daniel Franzen, MD University Hospital Zurich, Divison of Internal Medicine
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01694654     History of Changes
Other Study ID Numbers: SFT-1
Study First Received: September 24, 2012
Last Updated: September 26, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Pleural Neoplasms
Solitary Fibrous Tumor, Pleural
Solitary Fibrous Tumors
Neoplasms, Fibrous Tissue
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Pleural Diseases
Respiratory Tract Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 19, 2014