Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03270228 |
| Other study ID # |
NSP |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2017 |
| Est. completion date |
January 30, 2019 |
Study information
| Verified date |
December 2020 |
| Source |
Naestved Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The investigators want to determine the incidence of malignant disease, type of malignant
disease and overall survival in patients diagnosed with NSP after VATS.
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.
