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SCOT Registry: Small Cell Lung Cancer Treatment and Outcome (SCOT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00997061
First Posted: October 16, 2009
Last Update Posted: February 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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. ]

Secondary Outcome Measures:
  • survival rates [ Time Frame: 18 month period ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997061


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00997061     History of Changes
Other Study ID Numbers: 112791
First Submitted: October 15, 2009
First Posted: October 16, 2009
Last Update Posted: February 3, 2014
Last Verified: January 2014

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
Antineoplastic Agents