A Retrospective Study to Investigate the Current Situation of Biopsy Testing in Swedish Inoperable Non Small Cell Lung Cancer (NSCLC) Patients (MAPSY)
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ClinicalTrials.gov Identifier: NCT01139619 |
Recruitment Status
:
Completed
First Posted
: June 8, 2010
Last Update Posted
: February 25, 2013
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Tracking Information | |||||||
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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 |
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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. |
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Detailed Description | Not Provided | ||||||
Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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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. |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Completed | ||||||
Actual Enrollment |
136 | ||||||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | AstraZeneca | ||||||
Verification Date | February 2013 |