Improving Cancer Outcomes for Children, Adolescents, and Young Adults: A Multicenter Retrospective Cohort Study on Treatment Failure and Toxicity in Low- and Middle-Income Countries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18,000
- 试验地点
- 10
- 主要终点
- To estimate the incidence of Grade 3, 4, and 5 therapy-related toxicities in patients diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma.
研究概览
简要总结
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.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 回顾性
入排标准
- 年龄范围
- 0 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Subjects must meet all the following criteria to be included in this registry:
- Participants must be willing and able to provide informed consent prior to enrollment in the registry.
- For minors or individuals unable to provide informed consent, assent must be obtained along with consent from a legal guardian.
- 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).
- A confirmed diagnosis of any type of cancer within the 15 years prior to the site's activation date.
- Age 0 to 21 years at the time of diagnosis.
- Received substantial anti-cancer treatment at the participating center, including but not limited to:
- Chemotherapy
- Surgery
- Radiation therapy
- Immunotherapy
- Medical records are available and accessible for review
排除标准
- Subjects meeting any of the following criteria will be excluded from this registry:
- Patients who only visited the participating center for:
- Consultation without subsequent primary anti-cancer treatment at the participating center
- Pathology, radiology, or other diagnostic evaluations without treatment
- Patients who only visited the participating center for:
研究组 & 干预措施
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.
干预措施: Retrospective Medical Record Review (Other)
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.
干预措施: Retrospective Medical Record Review (Other)
结局指标
主要结局
To estimate the incidence of Grade 3, 4, and 5 therapy-related toxicities in patients diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma.
时间窗: 3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years)
To estimate the incidence of treatment failure, in patients with any type of cancer diagnosis.
时间窗: 3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years)
To estimate the incidence of therapy related toxicities in patients diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma.
时间窗: 3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years)
次要结局
- To estimate the event-free survival (EFS) and overall survival (OS) in patients diagnosed with any type of cancer.(3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years))
- To estimate the incidence of treatment failure by cancer type, treatment regimen, age groups, and sociodemographic variables of patients diagnosed with any cancer.(3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years))
- To estimate the incidence and severity of individual therapy- related toxicities in patients diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma.(3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years))
- To estimate the event-free survival (EFS) and overall survival (OS) for patients diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma.(3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years))
- To describe patterns of relapse in patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.(3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years))
研究者
研究点 (10)
标识符
- NCT 编号
- NCT07246213
- 其他研究编号
- RES-NIT-101-25
日期
- 首次提交
- (10个月前)
- 首次发布
- (10个月前)
- 主要完成日期
- (明年)
- 研究完成日期
- (2年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否
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.