CAYA Kræft Retrospektiv Kohortestudie
Forbedring af kræftresultater for børn, unge og unge voksne: En multicenter retrospektiv kohortestudie om behandlingssvigt og toksicitet i lav- og mellemindkomstlande
Despite advances in cancer treatment, significant disparities in outcomes persist between high-income countries (HICs) and low-and middle-income countries (LMICs). Around 80% of children with cancer live in LMICs, where they face challenges such as delayed diagnosis, misdiagnosis, comorbidities, distance to treatment, financial barriers, and limited access to risk-adapted therapies.
Acute lymphoblastic leukemia(ALL)/lymphoblastic lymphoma(LBL), for example, is one of the greatest success stories in pediatric oncology, however, such improvements are not evenly distributed worldwide, and the outcomes for leukemia patients are poorer in LMICs compared to HICs, primarily due to reduced access to quality healthcare.
This study aims to assess cancer treatment outcomes in LMICs, focusing on acute lymphoblastic leukemia/lymphoblastic lymphoma. The findings will inform future studies to implement evidence-based interventions that improve care quality and reduce treatment failures through targeted strategies.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Gabriela Villanueva, MD.
- Telefonnummer: +1-901-205-9518
- E-mail: gabriela.villanueva@resonancehealth.org
Studiesteder
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Yerevan, Armenien
- Rekruttering
- Yeolyan Center for Cancer and Blood Disorders
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Kontakt:
- Anna Avagyan, MD
- Telefonnummer: +010283800
- E-mail: avagyananna2010@gmail.com
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Cairo, Egypten
- Ikke rekrutterer endnu
- The Children's Cancer Hospital Egypt 57357
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Kontakt:
- Iman Sidhom, MD
- Telefonnummer: +202 25351500
- E-mail: iman.sidhom@57357.org
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Kontakt:
- Alaa El Haddad, MD
- E-mail: Alaa.Hadad@57357.org
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El Salvador
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El Salvador, El Salvador, El Salvador, 1101
- Rekruttering
- Fundación Ayúdame a Vivir
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Kontakt:
- Roberto Vasquez, MD.
- E-mail: rfranklinvz@gmail.com
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Guatemala City, Guatemala
- Rekruttering
- Unidad Nacional de Oncología Pediátrica (UNOP)
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Kontakt:
- Jeanine Alfaro, MD
- Telefonnummer: 502 50223177800
- E-mail: jalfaroflowcyt@ayuvi.org.gt
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Cortés Department
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San Pedro Sula, Cortés Department, Honduras, 21102
- Rekruttering
- Hospital Mario Catarino Rivas
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Kontakt:
- Roxana Martinez, MD.
- E-mail: roxmartinez@doctor.com
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Distrito Central
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Tegucigalpa, Distrito Central, Honduras, 11101
- Rekruttering
- Hospital Escuela
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Kontakt:
- Ligia Fu, MD.
- E-mail: ligiafucarrasco@yahoo.com
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Moshi, Tanzania
- Ikke rekrutterer endnu
- Kilimanjaro Christian Medical Center
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Kontakt:
- Esther Maialiwa, MD
- Telefonnummer: +255 755 001 312
- E-mail: mainda.emo@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
The study population will comprise pediatric patients aged 0-21 years diagnosed with cancer, reflecting diverse demographic backgrounds and clinical characteristics.
Beskrivelse
Inclusion Criteria:
Subjects must meet all the following criteria to be included in this registry:
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Participants must be willing and able to provide informed consent prior to enrollment in the registry.
- For minors or individuals unable to provide informed consent, assent must be obtained along with consent from a legal guardian.
- Note: Exemption applies to this criterion when waiver of informed consent/assent is granted by Institutional Review Board(IRB)/Independent Ethics Committee(IEC)/Competent Authorities(CAs).
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A confirmed diagnosis of any type of cancer within the 15 years prior to the site's activation date.
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Age 0 to 21 years at the time of diagnosis.
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Received substantial anti-cancer treatment at the participating center, including but not limited to:
- Chemotherapy
- Surgery
- Radiation therapy
- Immunotherapy
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Medical records are available and accessible for review
Exclusion Criteria:
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Subjects meeting any of the following criteria will be excluded from this registry:
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Patients who only visited the participating center for:
- Consultation without subsequent primary anti-cancer treatment at the participating center
- Pathology, radiology, or other diagnostic evaluations without treatment
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Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: RETROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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All Cancer Diagnoses
Patients aged 0-21 years with any type of cancer diagnosis. Retrospective medical record review will capture incidence of treatment failure, including relapse, progression, or abandonment. |
This study involves retrospective review of medical records of pediatric, adolescent, and young adult cancer patients (ages 0-21 years) treated at participating oncology centers in Guatemala, Honduras, El Salvador, Armenia, and Tanzania. No experimental drug, device, or behavioral intervention is being administered. Data abstraction will be performed to assess treatment failure, therapy-related toxicities, and clinical outcomes. |
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Acute Lymphoblastic Leukemia / Lymphoblastic Lymphoma
Patients aged 0-21 years diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma. Retrospective review will focus on therapy-related toxicities and treatment outcomes in this subgroup. |
This study involves retrospective review of medical records of pediatric, adolescent, and young adult cancer patients (ages 0-21 years) treated at participating oncology centers in Guatemala, Honduras, El Salvador, Armenia, and Tanzania. No experimental drug, device, or behavioral intervention is being administered. Data abstraction will be performed to assess treatment failure, therapy-related toxicities, and clinical outcomes. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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At estimere incidensen af behandlingssvigt hos patienter med enhver type kræftdiagnose.
Tidsramme: 3 år fra cancerdiagnosens dato (retrospektiv opfølgning via journaler; patienter uden en hændelse vil blive censureret ved sidste kontakt inden for 3 år)
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3 år fra cancerdiagnosens dato (retrospektiv opfølgning via journaler; patienter uden en hændelse vil blive censureret ved sidste kontakt inden for 3 år)
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To estimate the incidence of Grade 3, 4, and 5 therapy-related toxicities in patients diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma.
Tidsramme: 3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years)
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3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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At estimere incidensen af behandlingssvigt efter kræfttype, behandlingsregime, aldersgrupper og sociodemografiske variabler for patienter diagnosticeret med enhver form for kræft.
Tidsramme: 3 år fra datoen for cancerdiagnose (retrospektiv opfølgning via medicinske journaler; patienter uden en hændelse vil blive censureret ved sidste kontakt inden for 3 år)
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3 år fra datoen for cancerdiagnose (retrospektiv opfølgning via medicinske journaler; patienter uden en hændelse vil blive censureret ved sidste kontakt inden for 3 år)
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At estimere hændelsesfri overlevelse (EFS) og samlet overlevelse (OS) for patienter diagnosticeret med akut lymfatisk leukæmi eller lymfoblastisk lymfom.
Tidsramme: 3 år fra diagnosetidspunktet for kræft (retrospektiv opfølgning via journaler; patienter uden en hændelse vil blive censureret ved sidste kontakt inden for 3 år)
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3 år fra diagnosetidspunktet for kræft (retrospektiv opfølgning via journaler; patienter uden en hændelse vil blive censureret ved sidste kontakt inden for 3 år)
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At beskrive tilbagefaldsmønstre hos patienter med akut lymfatisk leukæmi eller lymfoblastisk lymfom.
Tidsramme: 3 år fra cancerdiagnose (retrospektiv opfølgning via journaler; patienter uden en hændelse vil blive censureret ved sidste kontakt inden for 3 år)
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3 år fra cancerdiagnose (retrospektiv opfølgning via journaler; patienter uden en hændelse vil blive censureret ved sidste kontakt inden for 3 år)
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To estimate the event-free survival (EFS) and overall survival (OS) in patients diagnosed with any type of cancer.
Tidsramme: 3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years)
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3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years)
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Generelle publikationer
- Toft N, Birgens H, Abrahamsson J, Griskevicius L, Hallbook H, Heyman M, Klausen TW, Jonsson OG, Palk K, Pruunsild K, Quist-Paulsen P, Vaitkeviciene G, Vettenranta K, Asberg A, Frandsen TL, Marquart HV, Madsen HO, Noren-Nystrom U, Schmiegelow K. Results of NOPHO ALL2008 treatment for patients aged 1-45 years with acute lymphoblastic leukemia. Leukemia. 2018 Mar;32(3):606-615. doi: 10.1038/leu.2017.265. Epub 2017 Aug 18.
- Chantada G, Lam CG, Howard SC. Optimizing outcomes for children with non-Hodgkin lymphoma in low- and middle-income countries by early correct diagnosis, reducing toxic death and preventing abandonment. Br J Haematol. 2019 Jun;185(6):1125-1135. doi: 10.1111/bjh.15785. Epub 2019 Feb 10.
- Howard SC, Zaidi A, Cao X, Weil O, Bey P, Patte C, Samudio A, Haddad L, Lam CG, Moreira C, Pereira A, Harif M, Hessissen L, Choudhury S, Fu L, Caniza MA, Lecciones J, Traore F, Ribeiro RC, Gagnepain-Lacheteau A. The My Child Matters programme: effect of public-private partnerships on paediatric cancer care in low-income and middle-income countries. Lancet Oncol. 2018 May;19(5):e252-e266. doi: 10.1016/S1470-2045(18)30123-2.
- Rodriguez-Galindo C, Friedrich P, Alcasabas P, Antillon F, Banavali S, Castillo L, Israels T, Jeha S, Harif M, Sullivan MJ, Quah TC, Patte C, Pui CH, Barr R, Gross T. Toward the Cure of All Children With Cancer Through Collaborative Efforts: Pediatric Oncology As a Global Challenge. J Clin Oncol. 2015 Sep 20;33(27):3065-73. doi: 10.1200/JCO.2014.60.6376. Epub 2015 Aug 24.
- Pui CH, Yang JJ, Bhakta N, Rodriguez-Galindo C. Global efforts toward the cure of childhood acute lymphoblastic leukaemia. Lancet Child Adolesc Health. 2018 Jun;2(6):440-454. doi: 10.1016/S2352-4642(18)30066-X. Epub 2018 Mar 30.
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RES-NIT-101-25
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
At this stage, the plan for sharing individual participant data (IPD) remains undecided. As the study continues to expand to new sites and additional countries, a comprehensive assessment of applicable data protection and privacy regulations in each jurisdiction is required. A final determination regarding IPD sharing will be made once compliance with all relevant national and international legal frameworks has been ensured.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .