We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01139619
First Posted: June 8, 2010
Last Update Posted: February 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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. ]
  • 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. ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01139619     History of Changes
Other Study ID Numbers: NIS-OSE-DUM-2010/1
First Submitted: June 2, 2010
First Posted: June 8, 2010
Last Update Posted: February 25, 2013
Last Verified: February 2013

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