- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02856646
Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Kentucky
-
Louisville, Kentucky, Forenede Stater, 40207
- Norton Cancer Institute
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
Population with Condition
Community Sample
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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
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CA209-655
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