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Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States

5. februar 2018 oppdatert av: Bristol-Myers Squibb
This study will collect real-world data from advanced melanoma diagnosis through most recent visit and data sourced from patient medical records following a 2-part study design consisting of a random sample (Part 1) and an oversample (Part 2).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

650

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New Jersey
      • Morristown, New Jersey, Forente stater, 07960
        • Local Institution

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients initiating a new line of therapy for unresectable stage III and/or metastatic (stage IV) melanoma during the index period between 01-Jan-2015 and 31-May-2016.

Beskrivelse

Inclusion Criteria:

  • Adults 18 years or older
  • Diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma before 01-Nov-2015
  • Initiating a new line of therapy during the index period between 01-Jan-2015 and 31-May-2016, irrespective of advanced melanoma diagnosis date
  • Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period)

Exclusion Criteria:

  • Physicians unwilling or unable to follow study instructions
  • Patients who were previously enrolled in a cancer treatment-related clinical trial since the diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
advanced melanoma patients
Part 1 will consist of a representative sample of advanced melanoma patients, irrespective of date of diagnosis of stage III unresectable and metastatic/stage IV, to address information objectives on treatment patterns, clinical outcomes, and resource use after the start of treatment post-launch of new drugs, ie, since 2011 for ipi and 2015 for ipi + nivo in advanced melanoma
Annen: Ikke-intervensjonell
Ikke-intervensjonell
Ipi monotherapy
Part 2: patients must have been prescribed Ipi monotherapy during the index period between 01-Jan-2015 and 31-May-2016.
Annen: Ikke-intervensjonell
Ikke-intervensjonell
Ipi + nivo combination therapy
Part 2: patients must have been prescribed Ipi + nivo combination therapy during the index period between 01-Jan-2015 and 31-May-2016.
Annen: Ikke-intervensjonell
Ikke-intervensjonell
Dabrafenib + trametinib combination therapy
Part 2: patients must have been prescribed Dabrafenib + trametinib combination therapy during the index period between 01-Jan-2015 and 31-May-2016.
Annen: Ikke-intervensjonell
Ikke-intervensjonell
Pembro monotherapy
Part 2: patients must have been prescribed Pembro monotherapy during the index period between 01-Jan-2015 and 31-May-2016
Annen: Ikke-intervensjonell
Ikke-intervensjonell
Nivo monotherapy
Part 2: patients must have been prescribed Nivo monotherapy during the index period between 01-Jan-2015 and 31-May-2016
Annen: Ikke-intervensjonell
Ikke-intervensjonell

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Distribution of treatment patterns for advanced melanoma patients
Tidsramme: Aproximately 6 months
Distribution of treatment patterns for advanced melanoma patients including, treatment regimen selection and rationale, as well as time to initiation of therapy and type of therapy
Aproximately 6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Distribution of prescribing patterns
Tidsramme: Approximately 16 months
Distribution of prescribing patterns by type of practice setting and melanoma patient volume
Approximately 16 months
Distribution of Patient Age at index date
Tidsramme: at baseline
Patient Age at index date will be determined from Medical Records
at baseline
Distribution of Patient's Sex at Index Date
Tidsramme: At Baseline
Patient's sex will be determined from Medical Records
At Baseline
Distribution of Comorbidities at index date
Tidsramme: At Baseline
Comorbidities will be determined using the Charlson Comorbidity Index (CCI)
At Baseline
Distribution of Healthcare Coverage type
Tidsramme: At Baseline
Healthcare Coverage type will be determined using Medical Records
At Baseline
Distribution of Diagnosis Date
Tidsramme: At Baseline
Melanoma Diagnosis Date will be determined using medical records
At Baseline
Distribution of Advanced Diagnosis Date
Tidsramme: At Baseline
Date of advanced/ metastatic melanoma diagnosis will be determined using medical records
At Baseline
Distribution of Age at Onset
Tidsramme: At Baseline
Diagnosis date-Date of Birth
At Baseline
Distribution of Disease stage at time of diagnosis
Tidsramme: At Baseline
Disease stage at time of diagnosis will be determined using medical records
At Baseline
Distribution of Disease stage at subsequent visits
Tidsramme: Approximately 16 months
Disease stage at subsequent visits will be determined using medical records
Approximately 16 months
Distribution of ECOG status at Baseline
Tidsramme: At Baseline
Eastern Cooperative Oncology Group (ECOG) status at Baseline will be determined using medical records
At Baseline
Distribution of ECOG status at Last Visit
Tidsramme: Approximately 16 months
Eastern Cooperative Oncology Group (ECOG) status at Last Visit will be determined using medical records
Approximately 16 months
Distribution of Biomarker status at baseline
Tidsramme: at baseline
Biomarker status will be determined using Medical Records
at baseline
Distribution of treatment-related adverse events
Tidsramme: Approximately 16 months
treatment-related adverse events will be determined using medical records
Approximately 16 months
Distribution of Overall Survival (OS) from Advanced Diagnosis
Tidsramme: Approximately 16 months
Date of death minus advanced/metastatic diagnosis date, censoring for LTF or end of observation
Approximately 16 months
Distribution of Progression-Free Survival (PFS) at Advanced Diagnosis
Tidsramme: Approximately 16 months
Date of progression (increase in tumor size or increase in cancer stage)/start of next line of therapy minus advanced/metastatic diagnosis date, censoring for LTF or end of observation
Approximately 16 months
Distribution of Overall Response Rate (ORR)
Tidsramme: Approximately 16 months
Approximately 16 months
Distribution of Overall Survival (OS) from Index Date
Tidsramme: Approximately 16 months
Date of death minus index treatment start date, censoring for LTF or end of observation
Approximately 16 months
Distribution of Progression-Free Survival (PFS) at Index Date
Tidsramme: Approximately 16 months
Date of progression (increase in tumor size or increase in cancer stage)/start of next line of therapy minus index treatment start date, censoring for LTF or end of observation
Approximately 16 months
Distribution of melanoma related HCRU
Tidsramme: Approximately 16 months
Approximately 16 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Bristol-Myers Squibb

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. oktober 2016

Primær fullføring (Faktiske)

30. oktober 2017

Studiet fullført (Faktiske)

31. desember 2017

Datoer for studieregistrering

Først innsendt

23. juni 2017

Først innsendt som oppfylte QC-kriteriene

23. juni 2017

Først lagt ut (Faktiske)

27. juni 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. februar 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. februar 2018

Sist bekreftet

1. februar 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CA209-983

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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Forhold

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