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

Non-Small Cell Lung Cancer Clinical Trial

— SCAN-LEAF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02839629
• Other study ID #: CA209-319
• Status: Completed
• Start date: November 23, 2015
• Est. completion date: May 7, 2021

Study information

• Verified date: January 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5657
• Est. completion date: May 7, 2021
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Age under 18 years at time of diagnosis

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Body Mass Index (BMI) of NSCLC patients at diagnosis		At baseline visit
Secondary	Smoking habits of NSCLC patients at diagnosis		At baseline visit
Secondary	Age of NSCLC patients at diagnosis		At baseline visit
Secondary	NSCLC clinical subtype of NSCLC patients at diagnosis		At baseline visit
Secondary	Tumor node metastasis classification of NSCLC patients at diagnosis		At baseline visit
Secondary	Charlson Comorbidity index of NSCLC patients at diagnosis		At baseline visit
Secondary	Drug utilization after NSCLC diagnosis by line of therapy		Approximately 2 years
Secondary	Proportion of patients who receive surgery by stage at treatment		Approximately 2 years
Secondary	Proportion of patients who receive radiation by stage at treatment		Approximately 2 years

External Links

•   BMS Clinical Trial Information
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