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Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices

14. december 2021 opdateret af: Bristol-Myers Squibb
The purpose of this study is to gather data on patients diagnosed with and treated for classical Hodgkin Lymphoma (cHL). It aims to closely observe how treatment for cHL is rendered, as well as assess the outcome of those treatment options and their impact on quality of life. Additional analyses will also attempt to identify prognostic or predictive biomarkers

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

290

Kontakter og lokationer

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

Studiesteder

    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40207
        • Norton Cancer Institute

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

Sandsynlighedsprøve

Studiebefolkning

Community Sample

Beskrivelse

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Histologically confirmed diagnosis of Classical Hodgkin Lymphoma (cHL)
  • Patients who are treatment-naïve, or are within ± 2 weeks beginning any line of therapy at time of enrollment
  • Patients must be within ± 2 weeks of Day 1 of the first cycle of any line of therapy to enroll; a cycle is practice-defined for chemotherapy, targeted therapy, or immunotherapy-based regimens.
  • Any Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status (PS)
  • Patients must have available medical records for the date of diagnosis of cHL and available medical records documenting any prior treatment and treatment dates for the Hodgkin lymphoma, including chemotherapy, radiation, surgery and other anti-cancer therapy received.
  • Patients must consent for use of their FFPE tissue blocks for exploratory analyses

Exclusion Criteria:

  • Patients on supportive care only and not receiving anti-cancer therapy are not eligible to enroll
  • Patients with unknown date of diagnosis of cHL
  • Patients whose prior cHL therapy, and dates of therapy (eg, surgery, radiation, or drug therapy) are unknown
  • Any other non-HL (non-Hodgkin Lymphoma) active malignancy for which the patient is receiving treatment
  • Patients participating in a clinical study that does not allow enrollment into a non-interventional study
  • Patients enrolled who go on to receive only supportive, palliative, hospice, or end-of-life care remain on study and should not be discontinued from follow-up.

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
Population with Condition
Community Sample

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Composite of Treatment Patterns
Tidsramme: Up to five years
What are the treatment patterns of therapies used to treat cHL (ie, incorporation of novel chemotherapy or non-chemotherapy to upfront therapy, chemotherapy/radiation and/or transplant sparring patterns, incorporation of immune checkpoint agents or other investigational therapies)
Up to five years
Overall Survival (OS)
Tidsramme: Up to five years
Up to five years
Progression Free Survival (PFS)
Tidsramme: Up to five years
Up to five years
Duration of Response
Tidsramme: Up to five years
Up to five years
Percentage of patients who achieve complete response
Tidsramme: Up to 5 years
Up to 5 years
Percentage of patients who achieve partial response
Tidsramme: Up to 5 years
Up to 5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Health-related quality of life (HRQoL)
Tidsramme: Up to five years
Up to five years
Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
Tidsramme: Up to five years
Up to five years
Drivers of Treatment Choice
Tidsramme: Up to five years

What are drivers of choice (eg. lack of response, safety, cost or other barriers to care) for:

treatment decisions across and between drug classes, changes and/or discontinuation in treatment, determinants of transplant eligibility/in-eligibility?

Up to five years
Healthcare resource utilization measured by imputed costs
Tidsramme: Up to five years
Up to five years
Grade of AE
Tidsramme: Up to 5 years
Up to 5 years

Samarbejdspartnere og efterforskere

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

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.

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)

7. oktober 2016

Primær færdiggørelse (Faktiske)

30. september 2020

Studieafslutning (Faktiske)

30. september 2020

Datoer for studieregistrering

Først indsendt

29. juli 2016

Først indsendt, der opfyldte QC-kriterier

2. august 2016

Først opslået (Skøn)

5. august 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. december 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. december 2021

Sidst verificeret

1. december 2021

Mere information

Begreber relateret til denne undersøgelse

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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