Clinical trial NCT01139619: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Keywords: Biopsy Mapping
Non small cell lung cancer
NSCLC
Lung cancer diagnosis
Retrospective
Inoperable Non Small Cell Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-06-08
Enrollment: 136
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Describe complications connected to biopsy and bronchoscopy in the investigated lung cancer population.
timeFrame: 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.
measure: Describe time to diagnosis for patients diagnosed by transthoracic biopsy compared to patients diagnosed by bronchoscopy.
timeFrame: 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.
measure: Describe difference in clinical outcome for patients diagnosed by histopathology compared to patients diagnosed by cytology alone, one year after diagnosis.
timeFrame: Data will be collected retrospectively from medical records. The time of data collection will be at least one year after diagnosis.
Secondary outcomes:
Other outcomes:
Locations:
city: Gavle
country: Sweden
facility: Research Site
city: Linkoping
country: Sweden
facility: Research Site
city: Lulea
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Dr Pål Falck, PhD
role: STUDY_DIRECTOR
affiliation: Gävle Hospital
name: Hirsh Koyi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: