Lung Cancer, Small CellSCOTNCT00997061
SCOT Registry: Small Cell Lung Cancer Treatment and Outcome
An observational study of Lung Cancer, Small Cell, run by GlaxoSmithKline at 61 sites in 14 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Small Cell
- What is being tested?
- HYCAMTIN
- How many people
- 500 participants
- Where
- 61 sitesin 14 countries
- Study dates
- Nov 2009to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly Diagnosed SCLC patients
Who may be able to join
- Male or Female >/= 18 years
- Diagnosis of small cell lung cancer
- Patient newly diagnosed with SCLC
- Has given written informed consent (if applicable)
Who cannot join
- 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.
Trial locations and contacts
61 sites in 14 countries.
61 sites in 14 countries
France11 sites
GSK Investigational Site
Besançon, 25030
GSK Investigational Site
Caen, 14033
GSK Investigational Site
Créteil, 94010
GSK Investigational Site
Draguignan, 83300
GSK Investigational Site
Lorient, 56322
GSK Investigational Site
Paris, 75020
GSK Investigational Site
Perpignan, 66000
GSK Investigational Site
Pessac, 33604
GSK Investigational Site
Pierre-Bénite, 69495
GSK Investigational Site
Saint-Priest-en-Jarez, 42271
GSK Investigational Site
Strasbourg, 67091
Germany9 sites
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53113
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51109
GSK Investigational Site
Hemer, North Rhine-Westphalia, 58675
GSK Investigational Site
Immenhausen, Hesse, 34376
GSK Investigational Site
Kassel, Hesse, 34125
GSK Investigational Site
Leer, Lower Saxony, 26789
GSK Investigational Site
Munich, Bavaria, 81925
GSK Investigational Site
Velbert, North Rhine-Westphalia, 42551
GSK Investigational Site
Wiesbaden, Hesse, 65199
Poland6 sites
GSK Investigational Site
Głuchołazy, 41-340
GSK Investigational Site
Gorzów Wielkopolski, 66-400
GSK Investigational Site
Krakow, 31-115
GSK Investigational Site
Lodz, 93-509
GSK Investigational Site
Lublin, 20-954
GSK Investigational Site
Warsaw, 00-909
Italy5 sites
GSK Investigational Site
Lecce, Apulia, 73100
GSK Investigational Site
Orbassano (TO), Piedmont, 10043
GSK Investigational Site
Parma, Emilia-Romagna, 43100
GSK Investigational Site
Rozzano (MI), Lombardy, 20089
GSK Investigational Site
Sassari, Sardinia, 07100
Spain5 sites
GSK Investigational Site
Córdoba, 14004
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Palma de Mallorca, 07014
GSK Investigational Site
Zaragoza, 50009
Austria4 sites
GSK Investigational Site
Graz, A-8036
GSK Investigational Site
Innsbruck, A-6020
GSK Investigational Site
Salzburg, 5020
GSK Investigational Site
Vienna, 1130
Lithuania4 sites
GSK Investigational Site
Kaunas, LT-50009
GSK Investigational Site
Klaipėda, LT-92228
GSK Investigational Site
Vilnius, LT-08660
GSK Investigational Site
Vilnius, LT-08661
Netherlands4 sites
GSK Investigational Site
Amsterdam, 1081 HV
GSK Investigational Site
Breda, 4818 CK
GSK Investigational Site
Eindhoven, 5623 EJ
GSK Investigational Site
Groningen, 9713 GZ
Greece3 sites
GSK Investigational Site
Athens, 115 27
GSK Investigational Site
Heraklion, Crete, 71110
GSK Investigational Site
Thessaloniki, 57010
South Korea3 sites
GSK Investigational Site
Seongnam-si, Gyeonggi-do, 463-707
GSK Investigational Site
Seoul, 137-701
GSK Investigational Site
Suwon, Gyeonggi-do, 442-723
Czechia2 sites
GSK Investigational Site
Brno, 625 00
GSK Investigational Site
Pilsen, 305 99
Hungary2 sites
GSK Investigational Site
Mátraháza, 3233
GSK Investigational Site
Székesfehérvár, 8000
Slovenia2 sites
GSK Investigational Site
Golnik, 4204
GSK Investigational Site
Ljubljana, 1000
About this study
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.
- Conditions
- Lung Cancer, Small Cell
- Being tested
- HYCAMTIN
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYCAMTINDrug
Observing patients on HYCAMTIN and other drugs for SCLC.
| Study group | Role | What they receive |
|---|---|---|
| HYCAMTIN | Not described Receives: Drug: HYCAMTIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Registry with disease, treatment and outcome data collected.
Measured: 6-9mth recruitment period, 18mth study duration.
Secondary outcomes (1)
survival rates
Measured: 18 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Small CellStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997061
- Sponsor's protocol ID
- 112791
- Acronym
- SCOT
- Status last verified
- Jan 2014
- First submitted
- 15 Oct 2009
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCOT Registry: Small Cell Lung Cancer Treatment and Outcome
- ClinicalTrials.gov ID
- NCT00997061
- Acronym / sponsor ID
- SCOT / 112791
- Conditions
- Lung Cancer, Small Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 16 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HYCAMTIN | – | Drug: HYCAMTIN |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly Diagnosed SCLC patients
Key inclusion criteria (4 listed)
- Male or Female >/= 18 years
- Diagnosis of small cell lung cancer
- Patient newly diagnosed with SCLC
- Has given written informed consent (if applicable)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HYCAMTINObserving patients on HYCAMTIN and other drugs for SCLC. | Drug | HYCAMTIN |
Primary outcome
Registry with disease, treatment and outcome data collected.
Time frame: 6-9mth recruitment period, 18mth study duration.
1 secondary outcome
survival rates
Time frame: 18 month period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
61 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, Small Cell, run by GlaxoSmithKline at 61 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in France, Germany, Poland, Italy, Spain and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Registry with disease, treatment and outcome data collected. (time frame: 6-9mth recruitment period, 18mth study duration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2014.