- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06507878
Globale data fra den virkelige verden hos patienter med avanceret skjoldbruskkirtelkræft om standardbehandling og specialiserede interventioner - Register over onkologiske resultater med test og behandling. (GRASSROOT)
The goal of this clinical research study is to learn about the barriers in the real world to accessing treatments for ATC. And to learn about how patients with ATC tolerate and respond to the commercially available medications for treatment of this disease, outside of a clinical study.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Primary Objectives:
The primary objective of this study is to compare overall survival (OS) between ATC patients treated at MDA versus outside of MDA using treatment regimens offered at MDA based on BRAF status and stage of the disease. We will gather prospective real-world, large-scale, comprehensive data on these patients who are unable to access traditional clinical trials but are treated with MDA regimens, assigned by stage and BRAF-status.
Secondary Objectives:
- To evaluate effect of chemotherapy, immunotherapy, and radiation therapy on the quality of life for ATC survivors
- To evaluate how factors such as health insurance and lack of coverage, adherence, and other sociodemographic characteristics influences patient outcomes.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Priyanka C Iyer, MBBS
- Telefonnummer: (832) 291-6069
- E-mail: piyer@mdanderson.org
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- Rekruttering
- MD Anderson Cancer Center
-
Kontakt:
- Priyanka C Iyer, MBBS
- Telefonnummer: 832-291-6069
- E-mail: piyer@mdanderson.org
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
MD Anderson Cancer Center
Beskrivelse
Inclusion Criteria:
All adult patients aged 18 years or older (with the exception of certain external participant countries where the legal adult age may be different; for example in Singapore, adult majors are defined by age 21 and older) with anaplastic thyroid cancer or poorly differentiated thyroid cancer as their clinical and/ or histological diagnosis will be included.
Exclusion Criteria:
Patients who do not have anaplastic thyroid cancer or poorly differentiated thyroid cancer on their tumor tissue would be excluded.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival
Tidsramme: Through study completion; an average of 1 year.
|
Prospective real-world, large-scale, comprehensive data on these patients who are unable to access traditional clinical trials but are treated with MDA regimens, assigned by stage and BRAF-status. |
Through study completion; an average of 1 year.
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Priyanka C Iyer, MBBS, M.D. Anderson Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
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
- 2024-0394
- NCI-2024-06148 (Anden identifikator: NIH/NCI)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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