A Retrospective Study to Investigate the Current Situation of Biopsy Testing in Swedish Inoperable Non Small Cell Lung Cancer (NSCLC) Patients (MAPSY)
A Retrospective, Medical Record Study to Investigate the Current Situation of Biopsy Testing in the Swedish Inoperable Non Small Cell Lung Cancer Patient Population
Lung cancer is one of the most deadly types of cancer and the leading cause of death in cancer in Sweden. Five year survival is 10% in men and 15% in women. Approximately 3300 individuals in Sweden are diagnosed each year and the incidence of adenocarcinoma is increasing. Lung cancer patients are to a great extent currently being diagnosed by exfoliative cytology. However, new drugs leading to more personalized treatments will demand more specific classification of tumour types. Today EGFR mutation status is becoming an important factor when deciding treatment strategy for patients with Non-Small Cell Lung cancer.
Sufficient tumour material must be available if EGFR mutation status is to be tested. Core needle biopsy is one way to obtain the quantity of material needed when testing mutation status. The portion of patients having core needle biopsies is believed to vary greatly between hospitals in Sweden, a difference from 20% to 70 % have been assumed, but is not yet confirmed in studies. This study will investigate the current situation and procedures when patients are diagnosed with lung cancer. The results can be used to describe any possible adverse events connected to the procedure and possibly contribute to development of a better decision tool to be used when deciding if a core needle biopsy is to be performed or not.
More and more therapeutical targets having similar problems are likely to be developed in the future. An investigation of current quality and procedures when diagnosing lung cancer by biopsies will facilitate future diagnosing of lung cancer and ensure that personalized treatments can be offered to patients.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Gavle, Suécia
- Research Site
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Linkoping, Suécia
- Research Site
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Lulea, Suécia
- Research Site
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Diagnosis code C34 (ICD-10).
- Inoperable lung cancer.
- Diagnosis of lung cancer made between 2010-05-31 and 2009-06-01.
Exclusion Criteria:
- Diagnosis code C34.9b.
- Diagnosis code C34.9h.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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1
Inoperable non small cell lung cancer patients.
Diagnosed between 2010-05-31 and 2009-06-01.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Describe complications connected to biopsy and bronchoscopy in the investigated lung cancer population.
Prazo: Data will be collected retrospectively from medical records. Data of complications will be collected from when the complication occurred and then any overnight stay caused by complication, approximately a few days.
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Data will be collected retrospectively from medical records. Data of complications will be collected from when the complication occurred and then any overnight stay caused by complication, approximately a few days.
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Describe time to diagnosis for patients diagnosed by transthoracic biopsy compared to patients diagnosed by bronchoscopy.
Prazo: Data will be collected retrospectively from medical records. The time span assessed will be from first contact at hospital to the date of diagnosis. Approximately a time frame of a few weeks up to several months.
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Data will be collected retrospectively from medical records. The time span assessed will be from first contact at hospital to the date of diagnosis. Approximately a time frame of a few weeks up to several months.
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Describe difference in clinical outcome for patients diagnosed by histopathology compared to patients diagnosed by cytology alone, one year after diagnosis.
Prazo: Data will be collected retrospectively from medical records. The time of data collection will be at least one year after diagnosis.
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Data will be collected retrospectively from medical records. The time of data collection will be at least one year after diagnosis.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Dr Pål Falck, PhD, AstraZeneca
- Investigador principal: Hirsh Koyi, MD PhD, Gävle Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NIS-OSE-DUM-2010/1
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