Clinical trial NCT00997061: SCOT Registry: Small Cell Lung Cancer Treatment and Outcome
Official title: SCOT Registry: Small Cell Lung Cancer Treatment and Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer, Small Cell
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-10-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly Diagnosed SCLC patients

Brief summary: The registry is an international, multicenter, observational registry of newly diagnosed patients with SCLC.

Data will be entered into an electronic CRF (eCRF) via Internet access. Treatment plan remains the responsibility of the patient's physician and data collected in this registry will reflect a "real world" approach of the diagnosis and treatment of patients with SCLC.

Approximately 60 centres in 13 countries will take part in this registry. It is expected that about 500 patients will be recruited during a period of 6 to 9 months according to the feasibility.


Eligibility criteria: Inclusion Criteria:

* Male or Female \>/= 18 years
* Diagnosis of small cell lung cancer
* Patient newly diagnosed with SCLC
* Has given written informed consent (if applicable)

Exclusion Criteria:

* Concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
* Patient presenting with recurrence of SCLC.
* Patients who has received any chemotherapy for the SCLC.

Primary outcomes:
measure: Registry with disease, treatment and outcome data collected.
timeFrame: 6-9mth recruitment period, 18mth study duration.
Secondary outcomes:
measure: survival rates
timeFrame: 18 month period
Other outcomes:
Locations:
city: Graz
country: Austria
facility: GSK Investigational Site
city: Innsbruck
country: Austria
facility: GSK Investigational Site
city: Salzburg
country: Austria
facility: GSK Investigational Site
city: Vienna
country: Austria
facility: GSK Investigational Site
city: Brno
country: Czech Republic
facility: GSK Investigational Site
city: Plzen
country: Czech Republic
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Besançon
country: France
facility: GSK Investigational Site
city: Caen
country: France
facility: GSK Investigational Site
city: Créteil
country: France
facility: GSK Investigational Site
city: Draguignan cedex
country: France
facility: GSK Investigational Site
city: Lorient cedex
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Perpignan
country: France
facility: GSK Investigational Site
city: Pessac cedex
country: France
facility: GSK Investigational Site
city: Pierre Benite
country: France
facility: GSK Investigational Site
city: Saint-Priest en Jarez
country: France
facility: GSK Investigational Site
city: Strasbourg
country: France
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Immenhausen
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Kassel
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Wiesbaden
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Leer
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bonn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Hemer
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Velbert
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Athens
country: Greece
facility: GSK Investigational Site
city: Heraklion, Crete
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Mátraháza
country: Hungary
facility: GSK Investigational Site
city: Székesfehérvár
country: Hungary
facility: GSK Investigational Site
city: Parma
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Rozzano (MI)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Orbassano (TO)
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Lecce
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Sassari
country: Italy
facility: GSK Investigational Site
state: Sardegna
city: Seongnam-si, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Klaipeda
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Breda
country: Netherlands
facility: GSK Investigational Site
city: Eindhoven
country: Netherlands
facility: GSK Investigational Site
city: Groningen
country: Netherlands
facility: GSK Investigational Site
city: Glucholazy
country: Poland
facility: GSK Investigational Site
city: Gorzow Wielkopolski
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Golnik
country: Slovenia
facility: GSK Investigational Site
city: Ljubljana
country: Slovenia
facility: GSK Investigational Site
city: Cordoba
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: Zaragoza
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: