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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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Gavle, Zweden
- Research Site
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Linkoping, Zweden
- Research Site
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Lulea, Zweden
- Research Site
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Describe complications connected to biopsy and bronchoscopy in the investigated lung cancer population.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Dr Pål Falck, PhD, AstraZeneca
- Hoofdonderzoeker: Hirsh Koyi, MD PhD, Gävle Hospital
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NIS-OSE-DUM-2010/1
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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