CAYA Cancer Prospective Cohort Study

Официальное название

Improving Cancer Outcomes for Children, Adolescents, and Young Adults: A Multicenter Prospective Cohort Study on Treatment Failure and Toxicity in Low- and Middle-Income Countries.

Обзор

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.

Первичные конечные точки

• Primary Outcome Measure [Срок оценки: From enrollment through 36 months of follow-up]

Вторичные конечные точки (1)

• Secondary Outcome Measures [Срок оценки: From enrollment through 36 months of follow-up]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Армения · 1 центр

• Yeolyan Center for Cancer and Blood Disorders — Yerevan

Египет · 1 центр

• The Children's Cancer Hospital Egypt 57357 — Cairo

Guatemala · 1 центр

• Unidad Nacional de Oncología Pediátrica (UNOP) — Guatemala City

Публикации

• 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, Par PMID 37694177
• 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. PMID 32056193
• 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. PMID 21503176
• 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. PMID 27184775
• 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. PMID 36579761
• 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. PMID 26210200
• 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. PMID 39173080
• 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. PMID 39268694

Идентификаторы

NCT: NCT07632014 · RES-NIT-102-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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