SCOT Registry: Small Cell Lung Cancer Treatment and Outcome

Lung Cancer, Small Cell Clinical Trial

— SCOT  

Official title:

SCOT Registry: Small Cell Lung Cancer Treatment and Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997061
• Other study ID #: 112791
• Status: Completed
• Phase: N/A
• First received: October 15, 2009
• Last updated: January 30, 2014
• Start date: November 2009
• Est. completion date: February 2012

Study information

• Verified date: January 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Státní ústav pro kontrolu léciv, Oddelení klinického hodnoceníSpain: Agencia Española del Medicamento y Productos SanitariosFrance: Conseil National de l'Ordre des MédecinsAustria: Agency for Health and Food SafetyNeherlands: Dutch Medical Research in Human Subjects Act (WMO).Italy: Isituto Superiore di Sanita'Poland: Centralna Ewidencja Badan Klinicznych Urzad Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów BiobójczychGermany: Federal Institute for Drugs and Medical DevicesSouth Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer, Small Cell
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• HYCAMTIN
Observing patients on HYCAMTIN and other drugs for SCLC.

Locations

Country	Name	City	State
Austria	GSK Investigational Site	Graz
Austria	GSK Investigational Site	Innsbruck
Austria	GSK Investigational Site	Salzburg
Austria	GSK Investigational Site	Vienna
Czech Republic	GSK Investigational Site	Brno
Czech Republic	GSK Investigational Site	Plzen
Estonia	GSK Investigational Site	Tallinn
France	GSK Investigational Site	Besançon
France	GSK Investigational Site	Caen
France	GSK Investigational Site	Créteil
France	GSK Investigational Site	Draguignan cedex
France	GSK Investigational Site	Lorient cedex
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Perpignan
France	GSK Investigational Site	Pessac cedex
France	GSK Investigational Site	Pierre Benite
France	GSK Investigational Site	Saint-Priest en Jarez
France	GSK Investigational Site	Strasbourg
Germany	GSK Investigational Site	Bonn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hemer	Nordrhein-Westfalen
Germany	GSK Investigational Site	Immenhausen	Hessen
Germany	GSK Investigational Site	Kassel	Hessen
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Leer	Niedersachsen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Velbert	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wiesbaden	Hessen
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Heraklion, Crete
Greece	GSK Investigational Site	Thessaloniki
Hungary	GSK Investigational Site	Mátraháza
Hungary	GSK Investigational Site	Székesfehérvár
Italy	GSK Investigational Site	Lecce	Puglia
Italy	GSK Investigational Site	Orbassano (TO)	Piemonte
Italy	GSK Investigational Site	Parma	Emilia-Romagna
Italy	GSK Investigational Site	Rozzano (MI)	Lombardia
Italy	GSK Investigational Site	Sassari	Sardegna
Korea, Republic of	GSK Investigational Site	Seongnam-si, Gyeonggi-do
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Suwon, Gyeonggi-do
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Klaipeda
Lithuania	GSK Investigational Site	Vilnius
Lithuania	GSK Investigational Site	Vilnius
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Breda
Netherlands	GSK Investigational Site	Eindhoven
Netherlands	GSK Investigational Site	Groningen
Poland	GSK Investigational Site	Glucholazy
Poland	GSK Investigational Site	Gorzow Wielkopolski
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Warszawa
Slovenia	GSK Investigational Site	Golnik
Slovenia	GSK Investigational Site	Ljubljana
Spain	GSK Investigational Site	Cordoba
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Palma de Mallorca
Spain	GSK Investigational Site	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Austria,  Czech Republic,  Estonia,  France,  Germany,  Greece,  Hungary,  Italy,  Korea, Republic of,  Lithuania,  Netherlands,  Poland,  Slovenia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Registry with disease, treatment and outcome data collected.		6-9mth recruitment period, 18mth study duration.	No
Secondary	survival rates		18 month period	No