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

NCT ID: NCT01139619

Last Updated: 2013-02-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 136 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-01-31

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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

1

Inoperable non small cell lung cancer patients. Diagnosed between 2010-05-31 and 2009-06-01.

No interventions assigned to this group

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Pål Falck, PhD

Role: STUDY_DIRECTOR

AstraZeneca

Hirsh Koyi, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Gävle Hospital

Locations

Research Site

Gävle, , Sweden

Research Site

Linköping, , Sweden

Research Site

Luleå, , Sweden

Countries

Sweden

Other Identifiers

NIS-OSE-DUM-2010/1

Identifier Type: -

Identifier Source: org_study_id