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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01139619
First received: June 2, 2010
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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.


Condition
Non Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 136
Study Start Date: October 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Inoperable non small cell lung cancer patients. Diagnosed between 2010-05-31 and 2009-06-01.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139619

Locations
Sweden
Research Site
Gavle, Sweden
Research Site
Linkoping, Sweden
Research Site
Lulea, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Dr Pål Falck, PhD AstraZeneca
Principal Investigator: Hirsh Koyi, MD PhD Gävle Hospital
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01139619     History of Changes
Other Study ID Numbers: NIS-OSE-DUM-2010/1
Study First Received: June 2, 2010
Last Updated: February 22, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
Biopsy Mapping
Non small cell lung cancer
NSCLC
Lung cancer diagnosis
Retrospective
Inoperable Non Small Cell Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014