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National Register Studies in Thoracic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03567538
Recruitment Status : Active, not recruiting
First Posted : June 25, 2018
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Ulrik Sartipy, MD, PhD, Karolinska University Hospital

Tracking Information
First Submitted Date June 13, 2018
First Posted Date June 25, 2018
Last Update Posted Date August 20, 2019
Actual Study Start Date January 1, 2018
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 13, 2018)
All-cause mortality [ Time Frame: 15 years ]
Death from any cause
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 13, 2018)
Postoperative complications [ Time Frame: 30 days ]
Complications related to surgery
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title National Register Studies in Thoracic Surgery
Official Title National Register Studies in Thoracic Surgery
Brief Summary The overall project aim is to study risk and outcomes following thoracic surgery by cross-linking high-quality national Swedish health-data registers for population-based investigations of individual level clinically relevant patient data.
Detailed Description

The purpose of this research project is to study risks and outcomes in patients who underwent thoracic surgery, primarily for lung cancer. We aim to establish a fundament for the conduct of nationwide population-based studies by linking patient-level data from the Swedish quality register for thoracic surgery (ThoR) and other national health-data registers maintained by the government agencies Statistics Sweden and the National Board of Health and Welfare. Cross-linking patient-level data is possible through the Personal Identity Number assigned to every individual who has resided in Sweden on a permanent basis. The Swedish Personal Identity Number is the unique identifier in all national registers.

Specifically, we aim:

  1. To analyze the association between socioeconomic factors and prognosis in patients undergoing pulmonary resection for lung cancer.
  2. To investigate the implementation of minimally invasive surgery for lung cancer in Sweden.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All adult patients who underwent thoracic surgery in Sweden during the study period
Condition
  • Lung Cancer
  • Pulmonary Metastasis
  • Surgery
Intervention Procedure: Thoracic surgery
Thoracic surgery, pulmonary resection, minimally invasive thoracic surgery, video assisted thoracic surgery (VATS)
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: June 13, 2018)
20000
Original Actual Enrollment Same as current
Estimated Study Completion Date January 2024
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

All adult patients who underwent thoracic surgery in Sweden during the study period

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT03567538
Other Study ID Numbers NatRegThx
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available to other researchers.
Responsible Party Ulrik Sartipy, MD, PhD, Karolinska University Hospital
Study Sponsor Karolinska University Hospital
Collaborators Karolinska Institutet
Investigators
Principal Investigator: Ulrik Sartipy, MD, PhD Karolinska University Hospital/Karolinska Institutet
PRS Account Karolinska University Hospital
Verification Date August 2019