Solitary Fibrous Tumors of the PleuraNCT01694654
Epidemiology and Outcome of Solitary Fibrous Tumors of the Pleura.
An observational study of Solitary Fibrous Tumors of the Pleura, run by University of Zurich at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Solitary Fibrous Tumors of the Pleura
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2012to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Histologically proven diagnosis of SFTP between 2000 and 2011.
Who may be able to join
- Histologically proven diagnosis of SFTP between 2000 and 2011.
Who cannot join
- Missing informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Internal Medicine
Zurich, Canton of Zurich, 8091
About this study
Official title: Epidemiology and Outcome of Solitary Fibrous Tumors of the Pleura. A Multicenter Study.
- To determine the incidence, prevalence and long-term outcome of patients with SFTP in the German spoken part of Switzerland.
- 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.
Read the 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.
- Conditions
- Solitary Fibrous Tumors of the Pleura
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solitary Fibrous Tumors of the PleuraStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Franzen, MD, Principal investigator, University Hospital Zurich, Divison of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694654
- Sponsor's protocol ID
- SFT-1
- Status last verified
- Apr 2016
- First submitted
- 24 Sep 2012
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Diebold M, Soltermann A, Hottinger S, Haile SR, Bubendorf L, Komminoth P, Jochum W, Grobholz R, Theegarten D, Berezowska S, Darwiche K, Oezkan F, Kohler M, Franzen DP. Prognostic value of MIB-1 proliferation index in solitary fibrous tumors of the pleura implemented in a new score - a multicenter study. Respir Res. 2017 Dec 16;18(1):210. doi: 10.1186/s12931-017-0693-8.
PubMed 29246159
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Outcome of Solitary Fibrous Tumors of the Pleura. A Multicenter Study.
- ClinicalTrials.gov ID
- NCT01694654
- Acronym / sponsor ID
- SFT-1
- Conditions
- Solitary Fibrous Tumors of the Pleura
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To determine the incidence, prevalence and long-term outcome of patients with SFTP in the German spoken part of Switzerland.
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Histologically proven diagnosis of SFTP between 2000 and 2011.
Key inclusion criteria (1 listed)
- Histologically proven diagnosis of SFTP between 2000 and 2011.
Key exclusion criteria (1 listed)
- Missing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Derived from this study: PubMed 29246159Diebold M, Soltermann A, Hottinger S, Haile SR, Bubendorf L, Komminoth P, Jochum W, Grobholz R, Theegarten D, Berezowska S, Darwiche K, Oezkan F, Kohler M, Franzen DP. Prognostic value of MIB-1 proliferation index in solitary fibrous tumors of the pleura implemented in a new score - a multicenter study. Respir Res. 2017 Dec 16;18(1):210. doi: 10.1186/s12931-017-0693-8.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Franzen, MD principal investigator
University Hospital Zurich, Divison of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solitary Fibrous Tumors of the Pleura, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01694654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.