SCOT Registry: Small Cell Lung Cancer Treatment and Outcome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00997061
First received: October 15, 2009
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Lung Cancer, Small Cell
Drug: HYCAMTIN

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: SCOT Registry: Small Cell Lung Cancer Treatment and Outcome

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Registry with disease, treatment and outcome data collected. [ Time Frame: 6-9mth recruitment period, 18mth study duration. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • survival rates [ Time Frame: 18 month period ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: November 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HYCAMTIN Drug: HYCAMTIN
Observing patients on HYCAMTIN and other drugs for SCLC.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Newly Diagnosed SCLC patients

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997061

  Show 61 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00997061     History of Changes
Other Study ID Numbers: 112791
Study First Received: October 15, 2009
Last Updated: January 30, 2014
Health Authority: Czech Republic: Státní ústav pro kontrolu léčiv, Oddělení klinického hodnocení
Spain: Agencia Española del Medicamento y Productos Sanitarios
France: Conseil National de l'Ordre des Médecins
Austria: Agency for Health and Food Safety
Neherlands: Dutch Medical Research in Human Subjects Act (WMO).
Italy: Isituto Superiore di Sanita'
Poland: Centralna Ewidencja Badań Klinicznych Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
Germany: Federal Institute for Drugs and Medical Devices
South Korea: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014