CAYA Kreft Retrospektiv Kohortstudie
Forbedring av kreftresultater for barn, ungdommer og unge voksne: En multikenter retrospektiv kohortstudie om behandlingssvikt og toksisitet i lav- og mellominntektsland
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Gabriela Villanueva, MD.
- Telefonnummer: +1-901-205-9518
- E-post: gabriela.villanueva@resonancehealth.org
Studiesteder
-
-
-
Yerevan, Armenia
- Rekruttering
- Yeolyan Center for Cancer and Blood Disorders
-
Ta kontakt med:
- Anna Avagyan, MD
- Telefonnummer: +010283800
- E-post: avagyananna2010@gmail.com
-
-
-
-
-
Cairo, Egypt
- Har ikke rekruttert ennå
- The Children's Cancer Hospital Egypt 57357
-
Ta kontakt med:
- Iman Sidhom, MD
- Telefonnummer: +202 25351500
- E-post: iman.sidhom@57357.org
-
Ta kontakt med:
- Alaa El Haddad, MD
- E-post: Alaa.Hadad@57357.org
-
-
-
-
El Salvador
-
El Salvador, El Salvador, El Salvador, 1101
- Rekruttering
- Fundación Ayúdame a Vivir
-
Ta kontakt med:
- Roberto Vasquez, MD.
- E-post: rfranklinvz@gmail.com
-
-
-
-
-
Guatemala City, Guatemala
- Rekruttering
- Unidad Nacional de Oncología Pediátrica (UNOP)
-
Ta kontakt med:
- Jeanine Alfaro, MD
- Telefonnummer: 502 50223177800
- E-post: jalfaroflowcyt@ayuvi.org.gt
-
-
-
-
Cortés Department
-
San Pedro Sula, Cortés Department, Honduras, 21102
- Rekruttering
- Hospital Mario Catarino Rivas
-
Ta kontakt med:
- Roxana Martinez, MD.
- E-post: roxmartinez@doctor.com
-
-
Distrito Central
-
Tegucigalpa, Distrito Central, Honduras, 11101
- Rekruttering
- Hospital Escuela
-
Ta kontakt med:
- Ligia Fu, MD.
- E-post: ligiafucarrasco@yahoo.com
-
-
-
-
-
Moshi, Tanzania
- Har ikke rekruttert ennå
- Kilimanjaro Christian Medical Center
-
Ta kontakt med:
- Esther Maialiwa, MD
- Telefonnummer: +255 755 001 312
- E-post: mainda.emo@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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:
-
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).
-
A confirmed diagnosis of any type of cancer within the 15 years prior to the site's activation date.
-
Age 0 to 21 years at the time of diagnosis.
-
Received substantial anti-cancer treatment at the participating center, including but not limited to:
- Chemotherapy
- Surgery
- Radiation therapy
- Immunotherapy
-
Medical records are available and accessible for review
Exclusion Criteria:
-
Subjects meeting any of the following criteria will be excluded from this registry:
-
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
-
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: RETROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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. |
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
For å estimere forekomsten av behandlingssvikt, hos pasienter med enhver type kreftdiagnose.
Tidsramme: 3 år fra kreftdiagnosedato (retrospektiv oppfølging via medisinske journaler; pasienter uten en hendelse vil bli sensurert ved siste kontakt innen 3 år)
|
3 år fra kreftdiagnosedato (retrospektiv oppfølging via medisinske journaler; pasienter uten en hendelse vil bli sensurert ved siste kontakt innen 3 år)
|
|
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)
|
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)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
For å estimere forekomsten av behandlingssvikt etter krefttype, behandlingsregime, aldersgrupper og sosiodemografiske variabler hos pasienter diagnostisert med kreft.
Tidsramme: 3 år fra kreftdiagnosedato (retrospektiv oppfølging via medisinske journaler; pasienter uten hendelse vil bli sensurert ved siste kontakt innen 3 år)
|
3 år fra kreftdiagnosedato (retrospektiv oppfølging via medisinske journaler; pasienter uten hendelse vil bli sensurert ved siste kontakt innen 3 år)
|
|
Å estimere hendelsesfri overlevelse (EFS) og total overlevelse (OS) for pasienter diagnostisert med akutt lymfatisk leukemi eller lymfoblastisk lymfom.
Tidsramme: 3 år fra kreftdiagnosedatoen (retrospektiv oppfølging via medisinske journaler; pasienter uten en hendelse vil bli sensurert ved siste kontakt innen 3 år)
|
3 år fra kreftdiagnosedatoen (retrospektiv oppfølging via medisinske journaler; pasienter uten en hendelse vil bli sensurert ved siste kontakt innen 3 år)
|
|
Å beskrive mønstre for tilbakefall hos pasienter med akutt lymfatisk leukemi eller lymfoblastisk lymfom.
Tidsramme: 3 år fra kreftdiagnosedato (retrospektiv oppfølging via medisinske journaler; pasienter uten hendelse vil bli sensurert ved siste kontakt innen 3 år)
|
3 år fra kreftdiagnosedato (retrospektiv oppfølging via medisinske journaler; pasienter uten hendelse vil bli sensurert ved siste kontakt innen 3 år)
|
|
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)
|
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)
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RES-NIT-101-25
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .