CAYA Cancer Prospective Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-21
SponsorResonance, Inc.
About this trial
Cancer is a leading cause of illness and death among children, adolescents, and young adults(CAYAs), especially in low- and middle-income countries(LMICs), where access to timely diagnosis and treatment is often limited. As a result, patients in these settings may experience higher rates of treatment complications, interruptions, and poorer outcomes compared with those in high-income countries (HICs).
This is a prospective, multicenter observational study that will follow children, adolescents, and young adults(CAYAs) with cancer who are receiving routine care at participating hospitals in low - and middle - income countries(LMICs). The study does not involve experimental treatments or changes to standard medical care. Information will be collected from medical records and from questionnaires that address access to care and social factors affecting treatment.
By describing treatment outcomes and the challenges patients and families face during cancer care, this study aims to provide data that can help inform future efforts to improve access to care and cancer outcomes in resource-limited settings.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 0 to 21 years at study enrollment.
Diagnosed with cancer and receiving active treatment or undergoing follow-up at the participating sites.
Willingness to provide informed consent/assent. For minors incapable of providing assent, or individuals unable to provide consent, consent must be obtained from a legal representative and in accordance with local requirements.
Disqualifiers
None
Trial population
The study population consists of children, adolescents and young adults aged 0 to 21 years diagnosed with cancer, who are receiving routine clinical care at participating hospitals in low- and middle-income countries(LMIC). Participants are enrolled prospectively and followed over time as part of an observational cohort to document clinical outcomes and factors related to access to care.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
6,000 Participants
are grouped into 1 trial groupGroup A: Children, Adolescents, and Young Adults With Cancer
Trial outcomes
Primary outcomes
1
Primary Outcome Measure
1. Incidence of treatment failure, dichotomous: Defined as the first occurrence of relapse, progressive disease, refractory disease, treatment-related death, diseaserelated death, treatment abandonment, or secondary malignancy; summarized as the 3-year cumulative incidence of the event. 2. Incidence of severe treatment-related toxicity (CTCAE v5.0), dichotomous: Defined as the first occurrence of any grade 3, 4 or 5 adverse event according to CTCAE 5.0; summarized as the 3-year cumulative incidence of the event.
Time frame
From enrollment through 36 months of follow-upSecondary outcomes
1
Secondary Outcome Measures
Event free survival (EFS), dichotomous time-to-event: First occurrence of death, relapse, progressive disease, refractory disease, treatment abandonment, or secondary malignancy; summarized as the 3-year EFS. Overall survival (OS), dichotomous time-to-event: Occurrence of death; summarized as the 3-year OS. Pattern of relapse, categorical: Site of disease recurrence after a complete remission, classified as isolated bone marrow, isolated CNS, isolated extramedullary, or combined relapse, or no recurrence, whichever occurs first, summarized as the percentage of each category. Treatment abandonment, dichotomous: Period of 4 weeks or more without receiving any protocol-specified therapy by patient/family decision; summarized as percentage. Treatment interruptions, dichotomous: Period of more than 7 days and less than 4 weeks in the initiation of a subsequent treatment cycle as specified by the treatment protocol; summarized as percentage.
Time frame
From enrollment through 36 months of follow-upOther outcomes
1
Other Outcome Measures
Total interval, numerical discrete: Defined as the time in days from the onset of the first symptom to the start of anti-cancer treatment; summarized as median time and interquartile range (IQR). Patient interval, numerical discrete: Defined as the time in days from the onset of the first cancer symptom to the first consultation with a healthcare professional; summarized as median time and IQR. Diagnostic interval, numerical discrete: Defined as the time in days from the first consultation with a healthcare professional to the date of a definitive cancer diagnosis; summarized as median time and IQR. Treatment interval, numerical discrete: Defined as the time in days from the date of a definitive cancer diagnosis to the day of starting anti-cancer treatment; summarized as median time and IQR.
Time frame
From enrollment through 36 months of follow up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Resonance, Inc.
Lead sponsor
Servier Affaires Médicales
Collaborator
Source ClinicalTrials.gov