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| Name | Class |
|---|---|
| Servier Affaires Médicales | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children, Adolescents, and Young Adults With Cancer | Participants include children, adolescents and young adults with a diagnosis of cancer who are receiving routine care at participating hospitals in low- and middle-income countries(LMIC). This study follows patients as part of a single observational cohort and does not assign any experimental treatments. All medical care is provided according to local standard practice. Participants are followed over time to document clinical outcomes, as well as factors related to access to care and the overall treatment experience. |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure |
| From enrollment through 36 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Subjects must meet all the following criteria to be included in this study:
Age 0 to 21 years at study enrollment.
Diagnosed with cancer and receiving active treatment or undergoing follow-up at the participating sites.
a. Note: Patients seen solely for consultation or diagnostic evaluations without subsequent treatment and those who have been off treatment for more than 5 years and are seen only for survivorship follow-up are not considered as meeting this criterion.
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.
Exclusion Criteria:
Subjects meeting any of the following criteria must be excluded from this study:
1. Any medical or psychological condition that, in the investigator's opinion, might compromise the ability of the patient to provide assent/informed consent/assent.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriela Villanueva, MD. | Contact | +1-901-205-9518 | gabriela.villanueva@resonancehealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yeolyan Center for Cancer and Blood Disorders | Recruiting | Yerevan | Armenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37694177 | Background | Nath A, Mathur P, Sudarshan KL, Kaur Rajput G, Mascarenhas L, Arora RS, Seth R, Kumar Dixit S, Chinnaswamy G, Banipal RPS, Bhutia TW, Kumar Bodal V, Budukh A, Kumar Chaudhary N, Vijay CR, Shikha Das D, Gundeti S, Harris C, Hazarika M, Natha Jondhale S, Gunaseelan K, Khamo V, Konjengbam R, Kumar A, Saroj Kumar DM, Majumdar G, Malik S, Mandal S, Najmi AM, Mohan Kumar C, Kumar Pandey A, Pandya S, Pareek P, Pautu JL, Surya Rao V, Ramesh C, Rawal M, Radhakrishnan N, Radhakrishnan V, Shah A, Singh SB, Singh V, Singh P, Sundriyal D, Swaminathan R, Avinash T, Priya Kumari T, Tawsik S, Tiwari L. An assessment of childhood cancer care services in India - gaps, challenges and the way forward. Lancet Reg Health Southeast Asia. 2023 Jun 20;16:100235. doi: 10.1016/j.lansea.2023.100235. eCollection 2023 Sep. | |
| 32056193 |
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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.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
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| From enrollment through 36 months of follow-up |
| From enrollment through 36 months of follow up. |
| The Children's Cancer Hospital Egypt 57357 | Recruiting | Cairo | 11441 | Egypt |
|
| Unidad Nacional de Oncología Pediátrica (UNOP) | Recruiting | Guatemala City | Guatemala |
|
| Background |
| Verma N, Bhattacharya S. Time to Diagnosis and Treatment of Childhood Cancer. Indian J Pediatr. 2020 Aug;87(8):641-643. doi: 10.1007/s12098-020-03217-y. Epub 2020 Feb 13. |
| 21503176 | Background | Brown BJ, Ajayi SO, Ogun OA, Oladokun RE. Factors influencing time to diagnosis of childhood cancer in Ibadan, Nigeria. Afr Health Sci. 2009 Dec;9(4):247-53. |
| 27184775 | Background | Njuguna F, Martijn H, Langat S, Musimbi J, Muliro H, Skiles J, Vik T, Sitaresmi MN, van de Ven PM, Kaspers GJ, Mostert S. Factors influencing time to diagnosis and treatment among pediatric oncology patients in Kenya. Pediatr Hematol Oncol. 2016 Apr;33(3):186-99. doi: 10.3109/08880018.2016.1169566. |
| 36579761 | Background | Cotache-Condor C, Kantety V, Grimm A, Williamson J, Landrum KR, Schroeder K, Staton C, Majaliwa E, Tang S, Rice HE, Smith ER. Determinants of delayed childhood cancer care in low- and middle-income countries: A systematic review. Pediatr Blood Cancer. 2023 Mar;70(3):e30175. doi: 10.1002/pbc.30175. Epub 2022 Dec 29. |
| 26210200 | Background | Bukowinski AJ, Burns KC, Parsons K, Perentesis JP, O'Brien MM. Toxicity of Cancer Therapy in Adolescents and Young Adults (AYAs). Semin Oncol Nurs. 2015 Aug;31(3):216-26. doi: 10.1016/j.soncn.2015.05.003. Epub 2015 May 7. |
| 39173080 | Background | Bamodu OA, Chung CC. Cancer Care Disparities: Overcoming Barriers to Cancer Control in Low- and Middle-Income Countries. JCO Glob Oncol. 2024 Aug;10:e2300439. doi: 10.1200/GO.23.00439. |
| 39268694 | Background | Chan A, Eng L, Jiang C, Dagsi M, Ke Y, Tanay M, Bergerot C, Dixit N, Gutierrez AC, Velazquez AI, Islami F, Soto-Perez-de-Celis E. Global disparities in cancer supportive care: An international survey. Cancer Med. 2024 Sep;13(17):e70234. doi: 10.1002/cam4.70234. |
| 39847745 | Background | Ariello K, Hadi AN, Denburg A, Gupta S. Survival Outcomes for Adolescent and Young Adults With Cancer in Low- and Middle-Income Countries: A Systematic Review. JCO Glob Oncol. 2025 Jan;11:e2400326. doi: 10.1200/GO-24-00326. Epub 2025 Jan 23. |
| 37517410 | Background | Ehrlich BS, McNeil MJ, Pham LTD, Chen Y, Rivera J, Acuna C, Sniderman L, Sakaan FM, Aceituno AM, Villegas CA, Force LM, Bolous NS, Wiphatphumiprates PP, Slone JS, Carrillo AK, Gillipelli SR, Duffy C, Arias AV, Devidas M, Rodriguez-Galindo C, Mukkada S, Agulnik A. Treatment-related mortality in children with cancer in low-income and middle-income countries: a systematic review and meta-analysis. Lancet Oncol. 2023 Sep;24(9):967-977. doi: 10.1016/S1470-2045(23)00318-2. Epub 2023 Jul 27. |
| 26304881 | Background | 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. |
| 39434099 | Background | Li W, Liang H, Wang W, Liu J, Liu X, Lao S, Liang W, He J. Global cancer statistics for adolescents and young adults: population based study. J Hematol Oncol. 2024 Oct 21;17(1):99. doi: 10.1186/s13045-024-01623-9. |
| 35326719 | Background | Derebas J, Panuciak K, Margas M, Zawitkowska J, Lejman M. The New Treatment Methods for Non-Hodgkin Lymphoma in Pediatric Patients. Cancers (Basel). 2022 Mar 18;14(6):1569. doi: 10.3390/cancers14061569. |
| 36907639 | Background | Temple WC, Mueller S, Hermiston ML, Burkhardt B. Diagnosis and management of lymphoblastic lymphoma in children, adolescents and young adults. Best Pract Res Clin Haematol. 2023 Mar;36(1):101449. doi: 10.1016/j.beha.2023.101449. Epub 2023 Feb 16. |
| 39717082 | Background | Hu Y, Liu Y, Fu J, Liu Y, Wang H, Song Y. Global, regional, and national burden of acute lymphoblastic leukemia in children: Epidemiological trends analysis from 1990 to 2021. iScience. 2024 Nov 23;27(12):111356. doi: 10.1016/j.isci.2024.111356. eCollection 2024 Dec 20. |
| 38572751 | Background | Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4. |
| 34086348 | Background | Bray F, Laversanne M, Weiderpass E, Soerjomataram I. The ever-increasing importance of cancer as a leading cause of premature death worldwide. Cancer. 2021 Aug 15;127(16):3029-3030. doi: 10.1002/cncr.33587. Epub 2021 Jun 4. |
| D006425 |
| Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |