- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03450876
Long Term Quality of Life in Melanoma Patients in Netherlands
9. september 2020 opdateret af: Bristol-Myers Squibb
A Prospective Multicenter Cohort Study of Late Physical Psychological and Social Effects in Patients Treated With Ipilimumab for Advanced Melanoma
Study of late physical, psychological and social effects in patients treated with ipilimumab for advanced (stage IV or unresectable stage III) melanoma.
Studieoversigt
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
89
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Amsterdam, Holland, 1066 CX
- Local Institution
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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
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with advanced melanoma who survived at least 2 years and were treated with ipilimumab between 2011 and 2015 in one of the specified melanoma centers in the Netherlands.
Beskrivelse
Inclusion Criteria-
- Patient population: Adults ≥ 18 years of age at diagnosis, diagnosed with histologically confirmed advanced (stage IV or unresectable stage III) melanoma, who have received at least one course of ipilimumab treatment (first, second, or second plus line; routine practice or study treatment) in one of the specified treatment centers, and who have survived at least 2 years after (completion of) ipilimumab treatment (measured from last ipilimumab administration)
- Matched healthy control population: Individuals without melanoma (stage III or IV) diagnosis that have been included in the PROFILES cohort
Exclusion Criteria
- Insufficient understanding of the Dutch language
- Other anticancer treatment after ipilimumab or during study entry
- Disease recurrence during the study
Other protocol defined inclusion/exclusion criteria could 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 |
Intervention / Behandling |
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Healthy Control
Individuals without melanoma (stage III or IV) diagnosis that have been included in the PROFILES cohort
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Ikke-interventionel
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24 to < 36 months post-ipilimumab treatment
24 to 36 month post-ipilimumab treatment advanced melanoma patients that were treated with ipilimumab in 2014 in one of the 14 melanoma centers in the Netherlands
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Ikke-interventionel
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≥ 36 to < 48 months post-ipilimumab treatment
36 to 48 month post-ipilimumab treatment advanced melanoma patients that were treated with ipilimumab in 2013 in one of the 14 melanoma centers in the Netherlands
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Ikke-interventionel
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≥ 48 months post-ipilimumab treatment
Greater than 48 month post-ipilimumab treatment advanced melanoma patients that were treated with ipilimumab between 2011 and 2012 in one of the 14 melanoma centers in the Netherlands
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Ikke-interventionel
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ C30)
Tidsramme: Baseline up to 3 years
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EORTC QLQ-C30 is a self-reported, 30-item generic questionnaire developed to assess 15 domains: global health status scale, five functional scales (physical, role, emotional, cognitive, and social functioning) and nine symptom scales (fatigue, nausea, vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties).
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Baseline up to 3 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Hospital Anxiety and Depression Scale (HADS)
Tidsramme: Baseline up to 3 years
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14-item questionnaire assesses symptoms of mood disturbance, yielding separate scale scores for anxiety and depression, as well as a total score
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Baseline up to 3 years
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Multidimensional Fatigue Inventory (MFI)
Tidsramme: Baseline up to 3 years
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Fatigue will be assessed with the Multidimensional Fatigue Inventory (MFI)
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Baseline up to 3 years
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Cancer Worry Scale (CWS)
Tidsramme: Baseline up to 3 years
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8-item questionnaire will be used to assess the prevalence of cancer-specific distress in melanoma survivors and in healthy controls
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Baseline up to 3 years
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European Organisation for Research and Treatment of Cancer Quality Of Life (EORTC QLQ) module for sexual health
Tidsramme: Baseline up to 3 years
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Sexual health will be assessed with the European Organisation for Research and Treatment of Cancer Quality Of Life (EORTC QLQ) module for sexual health
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Baseline up to 3 years
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Functional Assessment of Cancer Therapy-Melanoma questionnaire (FACT-M)
Tidsramme: Baseline up to 3 years
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51-item measurement of quality of life
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Baseline up to 3 years
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EuroQOL-5D (EQ-5D) survivors
Tidsramme: Baseline up to 3 years
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Generic health status will be assessed with the EuroQOL-5D (EQ-5D) survivors
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Baseline up to 3 years
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Impact of Cancer Questionnaire (IOCv2)
Tidsramme: Baseline up to 3 years
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81 items that present statements regarding specific impacts of cancer to which respondents indicate their level of agreement from 1 (strongly disagree) to 5 (strongly agree).
Seventy items apply to all survivors, 3 to currently employed respondents, 4 to respondents not currently partnered, and 4 to currently partnered respondents
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Baseline up to 3 years
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Work Ability Index questionnaire (WAI)
Tidsramme: Baseline up to 3 years
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13-item questionnaire developed to obtain survivors' experiences with return to work and work performance
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Baseline up to 3 years
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EORTC information module (EORTC QLQINFO25)
Tidsramme: Baseline up to 3 years
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Information needs will be assessed with the EORTC information module (EORTC QLQINFO25)
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Baseline up to 3 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
17. juni 2020
Studieafslutning (Faktiske)
17. juni 2020
Datoer for studieregistrering
Først indsendt
15. februar 2018
Først indsendt, der opfyldte QC-kriterier
28. februar 2018
Først opslået (Faktiske)
1. marts 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. september 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. september 2020
Sidst verificeret
1. september 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CA209-483
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
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National Cancer Institute (NCI)ExelisisAfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanom | Stage III Uveal Melanoma AJCC v7 | Stage IIIA Uveal Melanoma AJCC v7 | Stadie IIIB Uveal Melanoma AJCC v7 | Stage IIIC Uveal Melanoma AJCC v7Forenede Stater, Canada
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National Cancer Institute (NCI)AfsluttetFase IV kutan melanom AJCC v6 og v7 | Tilbagevendende melanom | Fase IIIC kutan melanom AJCC v7 | Slimhinde melanom | Iris melanom | Fase IIIA kutan melanom AJCC v7 | Fase IIIB kutan melanom AJCC v7 | Stage IV Uveal Melanoma AJCC v7 | Medium/Large Size Posterior Uveal Melanom | Tilbagevendende uveal melanom | Stage IIIA Uveal Melanoma AJCC v7 og andre forholdForenede Stater
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)AfsluttetFase IV kutan melanom AJCC v6 og v7 | Okulært melanom | Fase IIIC kutan melanom AJCC v7 | Kutant melanom | Slimhinde melanom | Fase IIIB kutan melanom AJCC v7 | Stage IV Uveal Melanoma AJCC v7 | Stadie IIIB Uveal Melanoma AJCC v7 | Stage IIIC Uveal Melanoma AJCC v7 | Stadie III Akral Lentiginøst Melanom AJCC... og andre forholdForenede Stater
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Sidney Kimmel Cancer Center at Thomas Jefferson...PfizerAktiv, ikke rekrutterendeCiliær krop og choroid melanom, medium/stor størrelse | Ciliær krop og choroidea melanom, lille størrelse | Iris melanom | Stadium IIIA Intraokulært melanom | Stadium IIIB Intraokulært melanom | Stadie IIIC Intraokulært melanom | Stadie I Intraokulært melanom | Stadie IIA Intraokulært melanom | Stadie IIB... og andre forholdForenede Stater
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)AfsluttetMetastatisk melanom | Fase IV kutan melanom AJCC v6 og v7 | Uoperabelt melanom | Slimhinde melanom | Stage IV Uveal Melanoma AJCC v7Forenede Stater
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National Cancer Institute (NCI)AfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanomForenede Stater
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National Cancer Institute (NCI)AfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanomForenede Stater, Frankrig, Det Forenede Kongerige
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National Cancer Institute (NCI)Memorial Sloan Kettering Cancer Center; Institut Curie Paris; Moffitt Cancer...Aktiv, ikke rekrutterendeMetastatisk uveal melanom | Stage IV Uveal Melanoma AJCC v7Forenede Stater
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)AfsluttetMetastatisk uveal melanom | Stage IV Uveal Melanoma AJCC v7Forenede Stater
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Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbAktiv, ikke rekrutterendeMetastatisk uveal melanom | Metastatisk malign neoplasma i leveren | Stage IV Uveal Melanoma AJCC v7Forenede Stater
Kliniske forsøg med Ikke-interventionel
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AstraZenecaAfsluttetBrystkræft | Onkologi | EpidemiologiAlgeriet
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AlvimedicaAfsluttetKarsygdomme | Koronararteriesygdom | Koronar sygdomKalkun
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The First Affiliated Hospital of Guangzhou Medical...UkendtKOL | Hyperkapnisk respirationssvigtKina
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Universidade Federal de PernambucoCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.AfsluttetCystisk fibroseBrasilien
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Jie LiBinzhou Medical UniversityAfsluttetKronisk obstruktiv lungesygdom med (akut) eksacerbationKina
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University Hospital, GrenobleRekrutteringHjertefejl | Lungesygdom, kronisk obstruktivFrankrig
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UPECLIN HC FM Botucatu UnespUkendtEkstubationsfejl | Akut respirationssvigt efter ekstubationBrasilien
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University Hospital, GrenobleAfsluttetRespiratorisk acidose hos ICU-patienterFrankrig
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Patri-cia Angelica de Miranda Silva NogueiraAfsluttet
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Fondazione Policlinico Universitario Agostino Gemelli...RekrutteringAkut hypoxæmisk respirationssvigtItalien