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Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)

11. januar 2022 opdateret af: Bristol-Myers Squibb

Treatment Patterns Among Patients With Advanced Small Cell Lung Cancer (SCLC) in Europe

Non-interventional, retrospective study of advanced SCLC patients in 4 European countries (France, Germany, Italy, and United Kingdom [UK]) with the aim to produce evidence across different SCLC treatment lines to characterize the clinical and economic burden of the disease in Europe.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

764

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Advanced SCLC patients in 4 European countries (France, Germany, Italy, and United Kingdom [UK]).

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Distribution of Patient Demographic Characteristics
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Approximately 44 months
Details on patients prior treatment Patterns will be summarized using descriptive statistics
Approximately 44 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Composite of SCLC-related healthcare resource utilization (HCRU)
Tidsramme: 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)
Tidsramme: Approximately 44 months
Approximately 44 months
Progression-free survival (PFS)
Tidsramme: Approximately 44 months
Approximately 44 months
Objective response rate (ORR)
Tidsramme: Approximately 44 months
Approximately 44 months
Mortality rate
Tidsramme: Approximately 44 months
Approximately 44 months
Treatment-related adverse events (AEs) leading to discontinuation
Tidsramme: Approximately 44 months
Approximately 44 months
Incidence of surgery as cancer-directed therapy
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bristol-Myers Squibb

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. december 2016

Primær færdiggørelse (Faktiske)

24. januar 2019

Studieafslutning (Faktiske)

24. januar 2019

Datoer for studieregistrering

Først indsendt

13. oktober 2017

Først indsendt, der opfyldte QC-kriterier

1. februar 2018

Først opslået (Faktiske)

8. februar 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. januar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. januar 2022

Sidst verificeret

1. januar 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CA209-913

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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