A Retrospective Study to Investigate the Current Situation of Biopsy Testing in Swedish Inoperable Non Small Cell Lung Cancer (NSCLC) Patients (MAPSY)

Tracking Information
First Submitted Date	June 2, 2010
First Posted Date	June 8, 2010
Last Update Posted Date	February 25, 2013
Study Start Date	October 2010
Actual Primary Completion Date	January 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: June 7, 2010)	Describe complications connected to biopsy and bronchoscopy in the investigated lung cancer population. [ Time Frame: 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. ]; Describe time to diagnosis for patients diagnosed by transthoracic biopsy compared to patients diagnosed by bronchoscopy. [ Time Frame: 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. ]; Describe difference in clinical outcome for patients diagnosed by histopathology compared to patients diagnosed by cytology alone, one year after diagnosis. [ Time Frame: Data will be collected retrospectively from medical records. The time of data collection will be at least one year after diagnosis. ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01139619 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	A Retrospective Study to Investigate the Current Situation of Biopsy Testing in Swedish Inoperable Non Small Cell Lung Cancer (NSCLC) Patients
Official Title	A Retrospective, Medical Record Study to Investigate the Current Situation of Biopsy Testing in the Swedish Inoperable Non Small Cell Lung Cancer Patient Population
Brief Summary	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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Approximately 200 inoperable non small cell lung cancer patients recruited from centers in Swedish University- and County hospitals.
Condition	Non Small Cell Lung Cancer
Intervention	Not Provided
Study Groups/Cohorts	1; Inoperable non small cell lung cancer patients. Diagnosed between 2010-05-31 and 2009-06-01.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: August 9, 2012)	136
Original Estimated Enrollment; (submitted: June 7, 2010)	200
Actual Study Completion Date	January 2013
Actual Primary Completion Date	January 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Sweden
Removed Location Countries
Administrative Information
NCT Number	NCT01139619
Other Study ID Numbers	NIS-OSE-DUM-2010/1
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	AstraZeneca
Study Sponsor	AstraZeneca
Collaborators	Not Provided
Investigators	Study Director: Dr Pål Falck, PhD AstraZeneca Principal Investigator: Hirsh Koyi, MD PhD Gävle Hospital
PRS Account	AstraZeneca
Verification Date	February 2013