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CAYA Cancer Retrospective Cohort Study

R

Resonance, Inc.

Status

Enrolling

Conditions

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

Treatments

Other: Retrospective Medical Record Review

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT07246213
RES-NIT-101-25

Details and patient eligibility

About

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.

Enrollment

18,000 estimated patients

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

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

Trial design

18,000 participants in 2 patient groups

All Cancer Diagnoses
Description:
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.
Treatment:
Other: Retrospective Medical Record Review
Acute Lymphoblastic Leukemia / Lymphoblastic Lymphoma
Description:
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.
Treatment:
Other: Retrospective Medical Record Review

Trial contacts and locations

5

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Central trial contact

Gabriela Villanueva, MD.

Data sourced from clinicaltrials.gov

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