Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
18000 participants
OBSERVATIONAL
2025-06-04
2028-12-04
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
Retrospective Medical Record Review
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.
Retrospective Medical Record Review
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.
Interventions
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Retrospective Medical Record Review
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.
Eligibility Criteria
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Inclusion Criteria
1. Participants must be willing and able to provide informed consent prior to enrollment in the registry.
1. For minors or individuals unable to provide informed consent, assent must be obtained along with consent from a legal guardian.
2. 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).
2. A confirmed diagnosis of any type of cancer within the 15 years prior to the site's activation date.
3. Age 0 to 21 years at the time of diagnosis.
4. Received substantial anti-cancer treatment at the participating center, including but not limited to:
1. Chemotherapy
2. Surgery
3. Radiation therapy
4. Immunotherapy
5. Medical records are available and accessible for review
Exclusion Criteria
1. Patients who only visited the participating center for:
1. Consultation without subsequent primary anti-cancer treatment at the participating center
2. Pathology, radiology, or other diagnostic evaluations without treatment
0 Years
21 Years
ALL
No
Sponsors
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Servier Affaires Médicales
INDUSTRY
Resonance, Inc.
OTHER
Responsible Party
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Locations
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Yeolyan Center for Cancer and Blood Disorders
Yerevan, , Armenia
Fundación Ayúdame a Vivir
El Salvador, El Salvador, El Salvador
Unidad Nacional de Oncología Pediátrica (UNOP)
Guatemala City, , Guatemala
Hospital Mario Catarino Rivas
San Pedro Sula, Cortés Department, Honduras
Hospital Escuela
Tegucigalpa, Distrito Central, Honduras
Countries
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Central Contacts
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Facility Contacts
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Anna Avagyan, MD
Role: primary
Roberto Vasquez, MD.
Role: primary
Jeanine Alfaro, MD
Role: primary
Roxana Martinez, MD.
Role: primary
Ligia Fu, MD.
Role: primary
References
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Lee TJ, Saito A. Altered cerebral vessel innervation in the spontaneously hypertensive rat. Circ Res. 1984 Sep;55(3):392-403. doi: 10.1161/01.res.55.3.392.
Erokhin VV. [Reaction of pulmonary tissue to the administration of weakly virulent Mycobacterium tuberculosis according to histochemical and electron microscopic data]. Arkh Patol. 1969;31(2):19-26. No abstract available. Russian.
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.
Other Identifiers
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RES-NIT-101-25
Identifier Type: -
Identifier Source: org_study_id