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

January 30, 2014 updated by: GlaxoSmithKline

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, A-8036
        • GSK Investigational Site
      • Innsbruck, Austria, A-6020
        • GSK Investigational Site
      • Salzburg, Austria, 5020
        • GSK Investigational Site
      • Vienna, Austria, 1130
        • GSK Investigational Site
  • Czech Republic
      • Brno, Czech Republic, 625 00
        • GSK Investigational Site
      • Plzen, Czech Republic, 305 99
        • GSK Investigational Site
  • Estonia
      • Tallinn, Estonia, 11619
        • GSK Investigational Site
  • France
      • 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
        • GSK Investigational Site
  • Germany
    • Bayern
      • Muenchen, Bayern, Germany, 81925
        • GSK Investigational Site
    • Hessen
      • Immenhausen, Hessen, Germany, 34376
        • GSK Investigational Site
      • Kassel, Hessen, Germany, 34125
        • GSK Investigational Site
      • Wiesbaden, Hessen, Germany, 65199
        • GSK Investigational Site
    • Niedersachsen
      • Leer, Niedersachsen, Germany, 26789
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53113
        • GSK Investigational Site
      • Hemer, Nordrhein-Westfalen, Germany, 58675
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germany, 51109
        • GSK Investigational Site
      • Velbert, Nordrhein-Westfalen, Germany, 42551
        • GSK Investigational Site
  • Greece
      • Athens, Greece, 115 27
        • GSK Investigational Site
      • Heraklion, Crete, Greece, 71110
        • GSK Investigational Site
      • Thessaloniki, Greece, 57010
        • GSK Investigational Site
  • Hungary
      • Mátraháza, Hungary, 3233
        • GSK Investigational Site
      • Székesfehérvár, Hungary, 8000
        • GSK Investigational Site
  • Italy
    • Emilia-Romagna
      • Parma, Emilia-Romagna, Italy, 43100
        • GSK Investigational Site
    • Lombardia
      • Rozzano (MI), Lombardia, Italy, 20089
        • GSK Investigational Site
    • Piemonte
      • Orbassano (TO), Piemonte, Italy, 10043
        • GSK Investigational Site
    • Puglia
      • Lecce, Puglia, Italy, 73100
        • GSK Investigational Site
    • Sardegna
      • Sassari, Sardegna, Italy, 07100
        • GSK Investigational Site
  • Korea, Republic of
      • 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
        • GSK Investigational Site
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • GSK Investigational Site
      • Klaipeda, Lithuania, LT-92228
        • GSK Investigational Site
      • Vilnius, Lithuania, LT-08660
        • GSK Investigational Site
      • Vilnius, Lithuania, LT-08661
        • GSK Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • GSK Investigational Site
      • Breda, Netherlands, 4818 CK
        • GSK Investigational Site
      • Eindhoven, Netherlands, 5623 EJ
        • GSK Investigational Site
      • Groningen, Netherlands, 9713 GZ
        • GSK Investigational Site
  • Poland
      • Glucholazy, Poland, 41-340
        • GSK Investigational Site
      • Gorzow Wielkopolski, Poland, 66-400
        • GSK Investigational Site
      • Krakow, Poland, 31-115
        • GSK Investigational Site
      • Lodz, Poland, 93-509
        • GSK Investigational Site
      • Lublin, Poland, 20-954
        • GSK Investigational Site
      • Warszawa, Poland, 00-909
        • GSK Investigational Site
  • Slovenia
      • Golnik, Slovenia, 4204
        • GSK Investigational Site
      • Ljubljana, Slovenia, 1000
        • GSK Investigational Site
  • Spain
      • Cordoba, Spain, 14004
        • GSK Investigational Site
      • Madrid, Spain, 28040
        • GSK Investigational Site
      • Madrid, Spain, 28034
        • GSK Investigational Site
      • Palma de Mallorca, Spain, 07014
        • GSK Investigational Site
      • Zaragoza, Spain, 50009
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Newly Diagnosed SCLC patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HYCAMTIN
Drug: HYCAMTIN
Observing patients on HYCAMTIN and other drugs for SCLC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Registry with disease, treatment and outcome data collected.
Time Frame: 6-9mth recruitment period, 18mth study duration.
6-9mth recruitment period, 18mth study duration.

Secondary Outcome Measures

Outcome Measure
Time Frame
survival rates
Time Frame: 18 month period
18 month period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

October 15, 2009

First Submitted That Met QC Criteria

October 15, 2009

First Posted (Estimate)

October 16, 2009

Study Record Updates

Last Update Posted (Estimate)

February 3, 2014

Last Update Submitted That Met QC Criteria

January 30, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112791

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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