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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 februari 2018 uppdaterad 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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Faktisk)

650

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • New Jersey
      • Morristown, New Jersey, Förenta staterna, 07960
        • Local Institution

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / 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
Övrig: Icke-interventionell
Icke-interventionell
Ipi monotherapy
Part 2: patients must have been prescribed Ipi monotherapy during the index period between 01-Jan-2015 and 31-May-2016.
Övrig: Icke-interventionell
Icke-interventionell
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.
Övrig: Icke-interventionell
Icke-interventionell
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.
Övrig: Icke-interventionell
Icke-interventionell
Pembro monotherapy
Part 2: patients must have been prescribed Pembro monotherapy during the index period between 01-Jan-2015 and 31-May-2016
Övrig: Icke-interventionell
Icke-interventionell
Nivo monotherapy
Part 2: patients must have been prescribed Nivo monotherapy during the index period between 01-Jan-2015 and 31-May-2016
Övrig: Icke-interventionell
Icke-interventionell

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Distribution of treatment patterns for advanced melanoma patients
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Distribution of prescribing patterns
Tidsram: 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
Tidsram: at baseline
Patient Age at index date will be determined from Medical Records
at baseline
Distribution of Patient's Sex at Index Date
Tidsram: At Baseline
Patient's sex will be determined from Medical Records
At Baseline
Distribution of Comorbidities at index date
Tidsram: At Baseline
Comorbidities will be determined using the Charlson Comorbidity Index (CCI)
At Baseline
Distribution of Healthcare Coverage type
Tidsram: At Baseline
Healthcare Coverage type will be determined using Medical Records
At Baseline
Distribution of Diagnosis Date
Tidsram: At Baseline
Melanoma Diagnosis Date will be determined using medical records
At Baseline
Distribution of Advanced Diagnosis Date
Tidsram: At Baseline
Date of advanced/ metastatic melanoma diagnosis will be determined using medical records
At Baseline
Distribution of Age at Onset
Tidsram: At Baseline
Diagnosis date-Date of Birth
At Baseline
Distribution of Disease stage at time of diagnosis
Tidsram: At Baseline
Disease stage at time of diagnosis will be determined using medical records
At Baseline
Distribution of Disease stage at subsequent visits
Tidsram: Approximately 16 months
Disease stage at subsequent visits will be determined using medical records
Approximately 16 months
Distribution of ECOG status at Baseline
Tidsram: 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
Tidsram: 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
Tidsram: at baseline
Biomarker status will be determined using Medical Records
at baseline
Distribution of treatment-related adverse events
Tidsram: Approximately 16 months
treatment-related adverse events will be determined using medical records
Approximately 16 months
Distribution of Overall Survival (OS) from Advanced Diagnosis
Tidsram: 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
Tidsram: 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)
Tidsram: Approximately 16 months
Approximately 16 months
Distribution of Overall Survival (OS) from Index Date
Tidsram: 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
Tidsram: 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
Tidsram: Approximately 16 months
Approximately 16 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Bristol-Myers Squibb

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 oktober 2016

Primärt slutförande (Faktisk)

30 oktober 2017

Avslutad studie (Faktisk)

31 december 2017

Studieregistreringsdatum

Först inskickad

23 juni 2017

Först inskickad som uppfyllde QC-kriterierna

23 juni 2017

Första postat (Faktisk)

27 juni 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 februari 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 februari 2018

Senast verifierad

1 februari 2018

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CA209-983

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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