- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03270228
Natural History of Nonspecific Pleuritis Diagnosed After Video-assisted-thoracoscopic-surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
Using Landspatientregisteret (LPR) (the National Patient register) the investigators will identify patients who have received a thoracoscopic pleural-biopsy using the SKS-codes KGAC01 and/or KGAA31 and/or KGAC00. From LPR and Cancerregisteret (the National Cancer-register) the investigators will receive diagnosis and additional descriptive data. From dødsårsagsregisteret (the National cause-of-death-register) death date and further descriptive data will be acquired.
Patients with NSP will be identified as patients with no diagnosis six months after pleural-biopsy, despite a thorough investigation.
Patients with a malignant effusion and non-malignant effusion (with known cause) will be used for survival analysis and comparison.
Data Data will be registered in the individual patients CRF (Case Report File) (digital) and will be transferred to a database-program for further processing. Background-variables will be used to describe the study population. Only study-coordinators will have access to data. All data including back-up will be stored and kept in a locked cupboard in a locked room. Only study coordinators possess relevant keys.
Statistics The investigators define significance level (α) as 0.05, and power (β) as 0.80. Descriptive data will be analysed using nonparametric statistics: Chi2-test for categorical data and Mann-Whitney for discrete data. Statistical significance is defined as: p-value < 0.05.
The overall survival of patients with NSP will be analysed using a Caplan-Meier plot and comparison of NSP patients to patients with malignant pleural-effusion the investigators use the Logrank test.
All statistical tests is conducted using STATA14 (4905 Lakeway Dr., College Station, TX 77845).
Ethics This study will not require the approval from Videnskabsetisk komité (the Health Research Ethics Committee), but approval will be sought from Datatilsynet (the Danish Data Protection Agency).
All results will be stored and analysed by computer, and the patients' anonymity will be secured according to the national laws. The data will be stored (anonymised), after completion of the study: data containing cpr.-numbers will be stored behind double-lock at the department.
No patients or investigators have economic incentives for completing the project.
Economy
Expenses related to gathering of data including contact with LPR, Dødsårsagsregisteret and the Danish Cancer Register are already financed through primary investigators PhD-project.
Publication The results from the study will be presented at international scientific congresses and published in international journals. Positive as well as negative results will be published. The scientists right to freely publish the results cannot be limited. All information will be passed anonymously.
The order of authors will follow the Vancouver Declaration, and will thus reflect the amount and significance of work relevant to the specific manuscript.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Naestved, Denmark, 4700
- Naestved Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients with a VATS thoracoscopy
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of cancer
Time Frame: 10 years
|
Percentage
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Type of cancer
Time Frame: 10 years
|
Lung cancer, mesothelioma etc.
|
10 years
|
Survival of patients
Time Frame: 10 years
|
Comparison of patients with a benign cause, a malignant cause and nonspecific pleuritis
|
10 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Simon Reuter, MD, PhD, Naestved Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pleural Effusion Due to Another Disorder (Disorder)
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Yale UniversityWithdrawnPleural Effusion | Malignant Pleural Effusion | Pleurodesis | Pleural Effusions, Chronic | Pleural Effusion Due to Congestive Heart Failure | Pleural Effusion in Conditions Classified Elsewhere
-
Scarlata, Simone, M.D.UnknownThoracic Ultrasound | Pleural Effusion DisorderItaly
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Assiut UniversityNot yet recruitingDisorder of Pleura and Pleural Cavity
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Oberwaid AGUniversity of Zurich; University of Basel; Institute for Exercise and Health...CompletedDepression | Sleep Disorder | Insomnia | Sleep Initiation and Maintenance Disorders | Sleep | Sleep Disturbance | Sleep Fragmentation | Insomnia Due to Other Mental Disorder | Insomnia, Psychophysiological | Insomnia Related to Another Mental ConditionSwitzerland
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University of GroningenZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedDepressive Disorder | Depression | Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant | Ultrarapid Metabolizer Due to Cytochrome P450 CYP2D6 Variant | Intermediate Metabolizer Due to Cytochrome P450 CYP2D6 VariantNetherlands
-
University Hospital, Strasbourg, FranceNot yet recruitingPleural Effusion | Frist Time Indication to Perform a Thoracentesis | Medical Student TrainingFrance
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Chang Gung Memorial HospitalCompletedVirus Diseases | Disorder Related to Transplantation | Injury Due to Exposure to External Cause
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Kyushu UniversityNovartis; Kurume University; Fukuoka University; University of Occupational and... and other collaboratorsUnknownVisual Disorder Due to Age-related Macula DegenerationJapan
-
Midwestern Regional Medical CenterWithdrawnXerostomia Due to Radiotherapy (Disorder)United States
-
University College, LondonWashington University School of Medicine; University of Washington; Alzheimer... and other collaboratorsNot yet recruitingAlzheimer Disease | Autosomal Dominant Alzheimer Disease Due to Mutation of Presenilin 1 (Disorder) | Autosomal Dominant Alzheimer Disease Due to Mutation of Presenilin 2 (Disorder) | Autosomal Dominant Alzheimer Disease Due to Mutation of Amyloid Precursor Protein (Disorder)
Clinical Trials on Nonspecific pleuritis after VATS thoracoscopy
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Naestved HospitalOdense University Hospital; Zealand University Hospital; Rigshospitalet, Denmark and other collaboratorsTerminated
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Peking University People's HospitalUnknown
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Peking University People's HospitalUnknownNon-small Cell Lung CancerChina
-
University of Cape TownCompletedEmpyema | HaemothoraxSouth Africa
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Assiut UniversityUnknown
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University of ChicagoNot yet recruitingLung Cancer | Gastric Adenocarcinoma | Metastatic Cancer | Liver Cancer | GI Cancer | Foregut Carcinoid Tumor | Gallbladder Adenocarcinoma | GI Carcinoma