- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03425825
Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)
Treatment Patterns Among Patients With Advanced Small Cell Lung Cancer (SCLC) in Europe
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Barcelona, Spanien, 08025
- Local Institution
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London, Vereinigtes Königreich, N19JY
- Local Institution
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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LD-SCLC receiving 1st line treatment
patients with LD-SCLC receiving first-line treatment, including potential maintenance treatment
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ED-SCLC receiving 1st line treatment
patients with ED-SCLC receiving first-line treatment, including potential maintenance treatment
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relapsed/refractory receiving 2nd or later-line treatment
relapsed/refractory patients receiving second- or later-line treatment
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Distribution of Patient Demographic Characteristics
Zeitfenster: At baseline
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Characteristics include: Age/month and year of birth Gender Ethnicity Weight Height Smoking status Alcohol consumption Other relevant risk factors |
At baseline
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Distribution of Patient Clinical Characteristics in Relapsed/refractory patients receiving second- or later-line treatment
Zeitfenster: At baseline
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Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
At baseline
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Distribution of Patient Clinical Characteristics in patients with LD-SCLC
Zeitfenster: At baseline
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Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
At baseline
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Distribution of Patient Clinical Characteristics in patients with ED-SCLC
Zeitfenster: At baseline
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Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
At baseline
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Distribution of treatment patterns in patients with ED-SCLC
Zeitfenster: Approximately 44 months
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Details on patients prior treatment Patterns will be summarized using descriptive statistics
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Approximately 44 months
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Distribution of treatment patterns in patients with LD-SCLC
Zeitfenster: Approximately 44 months
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Details on patients prior treatment Patterns will be summarized using descriptive statistics
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Approximately 44 months
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Distribution of treatment patterns in Relapsed/refractory patients receiving second- or later-line treatment
Zeitfenster: Approximately 44 months
|
Details on patients prior treatment Patterns will be summarized using descriptive statistics
|
Approximately 44 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Composite of SCLC-related healthcare resource utilization (HCRU)
Zeitfenster: Approximately 44 months
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HCRU will include hospitalizations, emergency visits, outpatient visits, treatments received (including treatments prescribed to manage AEs), diagnostic tests and procedures, surgery, and ancillary services.
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Approximately 44 months
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Overall survival (OS)
Zeitfenster: Approximately 44 months
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Approximately 44 months
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Progression-free survival (PFS)
Zeitfenster: Approximately 44 months
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Approximately 44 months
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Objective response rate (ORR)
Zeitfenster: Approximately 44 months
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Approximately 44 months
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Mortality rate
Zeitfenster: Approximately 44 months
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Approximately 44 months
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Treatment-related adverse events (AEs) leading to discontinuation
Zeitfenster: Approximately 44 months
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Approximately 44 months
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Incidence of surgery as cancer-directed therapy
Zeitfenster: Approximately 44 months
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To describe the use of surgery in the management of LD-SCLC and ED-SCLC patients having relapsed
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Approximately 44 months
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Incidence of radiation therapy as cancer-directed therapy
Zeitfenster: Approximately 44 months
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To describe the use of radiation therapy in the management of LD-SCLC and ED-SCLC patients having relapsed
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Approximately 44 months
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Incidence of best supportive care (BSC)
Zeitfenster: Approximately 44 months
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To describe the use of best supportive care (BSC) in the management of LD-SCLC and ED-SCLC patients having relapsed
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Approximately 44 months
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Incidence of palliative care
Zeitfenster: Approximately 44 months
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To describe the use of palliative care in the management of LD-SCLC and ED-SCLC patients having relapsed
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Approximately 44 months
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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CA209-913
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