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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 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

650

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • New Jersey
      • Morristown, New Jersey, Forenede Stater, 07960
        • Local Institution

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

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

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
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
Andet: Ikke-interventionel
Ikke-interventionel
Ipi monotherapy
Part 2: patients must have been prescribed Ipi monotherapy during the index period between 01-Jan-2015 and 31-May-2016.
Andet: Ikke-interventionel
Ikke-interventionel
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.
Andet: Ikke-interventionel
Ikke-interventionel
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.
Andet: Ikke-interventionel
Ikke-interventionel
Pembro monotherapy
Part 2: patients must have been prescribed Pembro monotherapy during the index period between 01-Jan-2015 and 31-May-2016
Andet: Ikke-interventionel
Ikke-interventionel
Nivo monotherapy
Part 2: patients must have been prescribed Nivo monotherapy during the index period between 01-Jan-2015 and 31-May-2016
Andet: Ikke-interventionel
Ikke-interventionel

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

Bristol-Myers Squibb

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)

25. oktober 2016

Primær færdiggørelse (Faktiske)

30. oktober 2017

Studieafslutning (Faktiske)

31. december 2017

Datoer for studieregistrering

Først indsendt

23. juni 2017

Først indsendt, der opfyldte QC-kriterier

23. juni 2017

Først opslået (Faktiske)

27. juni 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. februar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. februar 2018

Sidst verificeret

1. februar 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CA209-983

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 .

Kliniske forsøg med Melanom

Kliniske forsøg med Ikke-interventionel

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Sri Lanka

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner