CAYA Cancer Retrospective Cohort Study

NCT ID: NCT07246213

Last Updated: 2025-12-19

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

18000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-04

Study Completion Date

2028-12-04

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Young Adult Cancer Adolescent Cancer Childhood Cancers Acute Lymphoblastic Leukemia (ALL) Lymphoblastic Lymphoma (LBL)

Keywords

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Cancer outcomes Low- and Middle-Income Countries (LMICs) Childhood cancer Adolescent and young adult cancer (CAYA) Treatment failure Therapy-related toxicities Retrospective cohort Leukemia outcomes Oncology disparities High-Income Countries (HICs)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Subjects must meet all the following criteria to be included in this registry:

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

* Subjects meeting any of the following criteria will be excluded from this registry:

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
Minimum Eligible Age

0 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Servier Affaires Médicales

INDUSTRY

Sponsor Role collaborator

Resonance, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yeolyan Center for Cancer and Blood Disorders

Yerevan, , Armenia

Site Status RECRUITING

Fundación Ayúdame a Vivir

El Salvador, El Salvador, El Salvador

Site Status NOT_YET_RECRUITING

Unidad Nacional de Oncología Pediátrica (UNOP)

Guatemala City, , Guatemala

Site Status RECRUITING

Hospital Mario Catarino Rivas

San Pedro Sula, Cortés Department, Honduras

Site Status NOT_YET_RECRUITING

Hospital Escuela

Tegucigalpa, Distrito Central, Honduras

Site Status NOT_YET_RECRUITING

Countries

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Armenia El Salvador Guatemala Honduras

Central Contacts

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Gabriela Villanueva, MD.

Role: CONTACT

Phone: +1-901-205-9518

Email: [email protected]

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.

Reference Type BACKGROUND
PMID: 6467529 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4979198 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28819280 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30740656 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29726390 (View on PubMed)

Other Identifiers

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RES-NIT-101-25

Identifier Type: -

Identifier Source: org_study_id