Long-term Epidemiological Follow-up of Non-small Cell Lung Cancer in Scandinavia

NCT02839629 | Completed DMC

• 1 other identifier: CA209-319
• Study Type: observational
• Target: 5,657
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to describe and evaluate patient characteristics and clinical outcomes in Subjects with diagnosed Non Small Lung Cell Cancer in Sweden, Norway and Denmark.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (8)

• Overall survival based on Response Evaluation Criteria in Solid Tumors (RECIST)

  Overall survival is defined as the time from start of treatment to the end of follow-up; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease

  Approximately 2 years

• Progression free survival based on Response Evaluation Criteria in Solid Tumors (RECIST)

  Progression free survival is defined as the time from date of treatment start to either the first disease progression date or last known tumor assessment date or death; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease

  Approximately 2 years

• Time to progression based on Response Evaluation Criteria in Solid Tumors (RECIST)

  Time to progression is defined as time from start of therapy until tumor progression; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease

  Approximately 2 years

• Disease control rate; defined as total number of patients whose Best Overall Response(BOR)= Complete Response(CR), Partial Response(PR) or Stable Disease(SD), divided by total number of patients

  Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease; BOR: Best Overall Response, CR: Complete Response, PR: Partial Response, SD: Stable Disease

  Approximately 2 years

• Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST)

  Partial response is defined as a record of at least a 30% decrease in the sum of diameters of target lesions, from the baseline sum; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease

  Approximately 2 years

• Complete response based on Response Evaluation Criteria in Solid Tumors (RECIST)

  Complete response is defined as a record of disappearance of all target lesions; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease

  Approximately 2 years

• Percent of patients with an adverse event (AE)

  Patients with advanced stage (stage IIIB and above) disease; AEs are defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product

  Approximately 2 years

• Percent of patients with an adverse event (AE)

  Patients with earlier stage (stages I to IIA) disease; AEs are defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product

  Approximately 2 years

Secondary Outcomes (9)

• Body Mass Index (BMI) of NSCLC patients at diagnosis

  At baseline visit

• Smoking habits of NSCLC patients at diagnosis

  At baseline visit

• Age of NSCLC patients at diagnosis

  At baseline visit

• NSCLC clinical subtype of NSCLC patients at diagnosis

  At baseline visit

• Tumor node metastasis classification of NSCLC patients at diagnosis

  At baseline visit

Study Arms (2)

Cohort 1: National patient cohorts in Scandinavia

Scandinavian countries: Denmark, Norway and Sweden Cohort 1 will include all patients with a diagnosis of NSCLC between 2005 and 2013

Cohort 2: Electronic Medical Records based cohort (Sweden)

Patient as data is available (\~2010) to 2013

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of NSCLC

You may qualify if:

• Patients with a histologically confirmed diagnosis of NSCLC (squamous, adenocarcinoma, not otherwise specified NSCLC \[NSCLC NOS\]) identified in the Cancer registers

You may not qualify if:

• Age under 18 years at time of diagnosis

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 21, 2016
• Study Start: November 23, 2015
• Primary Completion: January 31, 2020
• Study Completion: May 7, 2021
• Last Updated: February 24, 2022

Record last verified: 2022-01