SCOT Registry: Small Cell Lung Cancer Treatment and Outcome
This study is ongoing, but not recruiting participants.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00997061
First received: October 15, 2009
Last updated: March 21, 2013
Last verified: March 2013
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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 ]
| Estimated Enrollment: | 500 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | March 2013 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997061
Locations
| Czech Republic | |
| GSK Investigational Site | |
| Brno, Czech Republic, 625 00 | |
| GSK Investigational Site | |
| Plzen, Czech Republic, 305 99 | |
| Estonia | |
| GSK Investigational Site | |
| Tallinn, Estonia, 11619 | |
| France | |
| GSK Investigational Site | |
| Besançon, France, 25030 | |
| GSK Investigational Site | |
| Caen, France, 14033 | |
| GSK Investigational Site | |
| Créteil, France, 94010 | |
| GSK Investigational Site | |
| Draguignan cedex, France, 83300 | |
| GSK Investigational Site | |
| Lorient cedex, France, 56322 | |
| GSK Investigational Site | |
| Paris, France, 75020 | |
| GSK Investigational Site | |
| Perpignan, France, 66000 | |
| GSK Investigational Site | |
| Pessac cedex, France, 33604 | |
| GSK Investigational Site | |
| Pierre Benite, France, 69495 | |
| GSK Investigational Site | |
| Saint-Priest en Jarez, France, 42271 | |
| GSK Investigational Site | |
| Strasbourg, France, 67091 | |
| Hungary | |
| GSK Investigational Site | |
| Székesfehérvár, Hungary, 8000 | |
| Korea, Republic of | |
| GSK Investigational Site | |
| Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707 | |
| GSK Investigational Site | |
| Seoul, Korea, Republic of, 137-701 | |
| GSK Investigational Site | |
| Suwon, Gyeonggi-do, Korea, Republic of, 442-723 | |
| Netherlands | |
| GSK Investigational Site | |
| Eindhoven, Netherlands, 5623 EJ | |
| Poland | |
| GSK Investigational Site | |
| Glucholazy, Poland, 41-340 | |
| GSK Investigational Site | |
| Lodz, Poland, 93-509 | |
| GSK Investigational Site | |
| Lublin, Poland, 20-954 | |
| Slovenia | |
| GSK Investigational Site | |
| Golnik, Slovenia, 4204 | |
| GSK Investigational Site | |
| Ljubljana, Slovenia, 1000 | |
| Spain | |
| GSK Investigational Site | |
| Cordoba, Spain, 14004 | |
| GSK Investigational Site | |
| Madrid, Spain, 28034 | |
| GSK Investigational Site | |
| Madrid, Spain, 28040 | |
| GSK Investigational Site | |
| Palma de Mallorca, Spain, 07014 | |
| GSK Investigational Site | |
| Zaragoza, Spain, 50009 | |
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: | March 21, 2013 |
| 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 May 23, 2013