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Completed

NCT Number: NCT02839629

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Approximately 2 years

    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

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

    Time frame: Approximately 2 years

    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

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

    Time frame: Approximately 2 years

    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

  4. 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

    Time frame: Approximately 2 years

    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

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

    Time frame: Approximately 2 years

    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

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

    Time frame: Approximately 2 years

    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

  7. Percent of patients with an adverse event (AE)

    Time frame: Approximately 2 years

    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

  8. Percent of patients with an adverse event (AE)

    Time frame: Approximately 2 years

    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

Secondary outcomes

  1. Body Mass Index (BMI) of NSCLC patients at diagnosis

    Time frame: At baseline visit

  2. Smoking habits of NSCLC patients at diagnosis

    Time frame: At baseline visit

  3. Age of NSCLC patients at diagnosis

    Time frame: At baseline visit

  4. NSCLC clinical subtype of NSCLC patients at diagnosis

    Time frame: At baseline visit

  5. Tumor node metastasis classification of NSCLC patients at diagnosis

    Time frame: At baseline visit

  6. Charlson Comorbidity index of NSCLC patients at diagnosis

    Time frame: At baseline visit

  7. Drug utilization after NSCLC diagnosis by line of therapy

    Time frame: Approximately 2 years

  8. Proportion of patients who receive surgery by stage at treatment

    Time frame: Approximately 2 years

  9. Proportion of patients who receive radiation by stage at treatment

    Time frame: Approximately 2 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Acronym: SCAN-LEAF

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Jul 21, 2016
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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