- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03425825
Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)
Treatment Patterns Among Patients With Advanced Small Cell Lung Cancer (SCLC) in Europe
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
-
London, Spojené království, N19JY
- Local Institution
-
-
-
-
-
Barcelona, Španělsko, 08025
- Local Institution
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
Cohort 1 and 2:
- Patients 18 years of age or older at SCLC diagnosis
- Confirmed diagnosis of SCLC within the patient identification period (between October 2013 and October 2015)
- Initiated on first-line treatment (radiotherapy and/or chemotherapy) for their SCLC
- Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first)
- Signed informed consent (where required as per local requirements)
Cohort 3:
- Patients 18 years of age or older at SCLC diagnosis
- Confirmed diagnosis of SCLC not earlier than October 2013
- Initiated on second-line treatment due to relapse after first-line therapy not later than August 2016
- Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first)
- Signed informed consent (where required as per local requirements)
Exclusion Criteria:
- Participants with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to first treatment and no additional therapy is required or anticipated to be required during the study period.
Other Inclusion/Exclusion criteria may apply
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
---|
LD-SCLC receiving 1st line treatment
patients with LD-SCLC receiving first-line treatment, including potential maintenance treatment
|
ED-SCLC receiving 1st line treatment
patients with ED-SCLC receiving first-line treatment, including potential maintenance treatment
|
relapsed/refractory receiving 2nd or later-line treatment
relapsed/refractory patients receiving second- or later-line treatment
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Distribution of Patient Demographic Characteristics
Časové okno: At baseline
|
Characteristics include: Age/month and year of birth Gender Ethnicity Weight Height Smoking status Alcohol consumption Other relevant risk factors |
At baseline
|
Distribution of Patient Clinical Characteristics in Relapsed/refractory patients receiving second- or later-line treatment
Časové okno: At baseline
|
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
At baseline
|
Distribution of Patient Clinical Characteristics in patients with LD-SCLC
Časové okno: At baseline
|
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
At baseline
|
Distribution of Patient Clinical Characteristics in patients with ED-SCLC
Časové okno: At baseline
|
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
At baseline
|
Distribution of treatment patterns in patients with ED-SCLC
Časové okno: Approximately 44 months
|
Details on patients prior treatment Patterns will be summarized using descriptive statistics
|
Approximately 44 months
|
Distribution of treatment patterns in patients with LD-SCLC
Časové okno: Approximately 44 months
|
Details on patients prior treatment Patterns will be summarized using descriptive statistics
|
Approximately 44 months
|
Distribution of treatment patterns in Relapsed/refractory patients receiving second- or later-line treatment
Časové okno: Approximately 44 months
|
Details on patients prior treatment Patterns will be summarized using descriptive statistics
|
Approximately 44 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Composite of SCLC-related healthcare resource utilization (HCRU)
Časové okno: Approximately 44 months
|
HCRU will include hospitalizations, emergency visits, outpatient visits, treatments received (including treatments prescribed to manage AEs), diagnostic tests and procedures, surgery, and ancillary services.
|
Approximately 44 months
|
Overall survival (OS)
Časové okno: Approximately 44 months
|
Approximately 44 months
|
|
Progression-free survival (PFS)
Časové okno: Approximately 44 months
|
Approximately 44 months
|
|
Objective response rate (ORR)
Časové okno: Approximately 44 months
|
Approximately 44 months
|
|
Mortality rate
Časové okno: Approximately 44 months
|
Approximately 44 months
|
|
Treatment-related adverse events (AEs) leading to discontinuation
Časové okno: Approximately 44 months
|
Approximately 44 months
|
|
Incidence of surgery as cancer-directed therapy
Časové okno: Approximately 44 months
|
To describe the use of surgery in the management of LD-SCLC and ED-SCLC patients having relapsed
|
Approximately 44 months
|
Incidence of radiation therapy as cancer-directed therapy
Časové okno: Approximately 44 months
|
To describe the use of radiation therapy in the management of LD-SCLC and ED-SCLC patients having relapsed
|
Approximately 44 months
|
Incidence of best supportive care (BSC)
Časové okno: Approximately 44 months
|
To describe the use of best supportive care (BSC) in the management of LD-SCLC and ED-SCLC patients having relapsed
|
Approximately 44 months
|
Incidence of palliative care
Časové okno: Approximately 44 months
|
To describe the use of palliative care in the management of LD-SCLC and ED-SCLC patients having relapsed
|
Approximately 44 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CA209-913
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Rakovina plic
-
Indiana UniversityRichard L. Roudebush VA Medical CenterDokončeno
-
Novartis PharmaceuticalsDokončenoNeuroendokrinní nádory | Advanced NET of GI Origin | Advanced NET of Lung OriginSpojené státy, Kolumbie, Itálie, Tchaj-wan, Spojené království, Belgie, Česko, Německo, Japonsko, Saudská arábie, Kanada, Holandsko, Španělsko, Korejská republika, Libanon, Rakousko, Čína, Řecko, Jižní Afrika, Thajsko, Maďarsko, Krocan a více
-
Assiut UniversityZatím nenabírámeRakovina plic | Poranění plic | Bleb Lung
-
SanofiRegeneron PharmaceuticalsDokončenoKarcinom | Non Small Cell LungSpojené státy, Francie, Kanada, Brazílie, Polsko, Rumunsko, Ruská Federace, Německo, Itálie, Holandsko, Portugalsko, Španělsko, Švédsko, Bulharsko, Estonsko, Indie, Malajsie, Singapur, Tchaj-wan, Česká republika, Argentina, Finsko, Ma... a více
-
University of LorraineDokončenoDítě, Pouze | Spontánní pneumotorax | Idiopatický pneumotorax | Bleb LungFrancie
-
Jiangsu HengRui Medicine Co., Ltd.NeznámýNon Small Cell LungČína