Neuroendocrine Carcinomas: Patient Journey And Treatment Outcomes In Latin America
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 19
- 主要终点
- Patterns of Initial Cancer Treatment: number of participants treated within vs. outside high-volume sites and associated treatment characteristics
研究概览
简要总结
This observational, retrospective study aims to understand the treatment patterns and outcomes of patients with pulmonary and extra-pulmonary neuroendocrine carcinomas (NEC) in Latin America (Brazil, Mexico, Argentina, and Peru). The research will collect data from medical records to analyze factors like patient demographics, diagnosis methods, tumor characteristics, treatment approaches, and disease progression. The study is non-interventional, meaning patient care will follow standard clinical practice, with data gathered via an electronic system.
详细描述
Currently, there is a hypothesis that there is not enough evidence to fully understand the patient journey and accurately determine the clinical outcomes of neuroendocrine carcinomas (NEC) in Latin America. A better understanding of this landscape, including its unique regional aspects, could lead to improved patient care.
To address this gap, this observational, retrospective, non-interventional study aims to describe treatment patterns and outcomes for patients with both pulmonary and extra-pulmonary NEC in Latin America. Eligible patients diagnosed with either form of NEC will be included, and data will be collected from medical records at selected sites across Brazil, Mexico, Argentina, and Peru.
Data to be retrieved include but are not limited to age at diagnosis, gender, ECOG at diagnosis, stage (TNM), resources used for primary diagnosis (imaging, upfront surgery etc.), primary site, tumor size and grade, setting of initial treatment (reference center vs community hospital), type of initial surgical approach, data of anti-cancer treatments (including (neo)adjuvant and advanced settings) and relapse and/or progression/death. Data regarding anti-cancer treatments (including (neo)adjuvant and advanced settings), as well as radiotherapy use will also be recorded.
As this project is non-interventional, patients will still receive treatment and clinical assessments for extra-pulmonary and pulmonary NEC as determined by their attending physician, according to the standard of care and routine clinical practice at each site. No visits are demanded by the study, but for those required for the consent process whenever determined by the local ethics committee. Patient source data will be taken from the patient's medical records and reported by means of an electronic data capture (EDC) system.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Diagnosed between August 2014 and August 2024 with one of the following:
- •Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)
- •Large-cell neuroendocrine carcinoma (LCNEC) or mixed
- •Small Cell Lung Cancer (SCLC) or mixed
- •Adequate and accessible medical records for data collection
- •Tumor block collected from 2014 onwards
排除标准
- •Patients with active, concurrent malignancies at the time of NEC diagnosis, except for non-invasive cancers like basal cell carcinoma or squamous cell carcinoma of the skin, or in situ cervical cancer.
- •Patients or their legal representatives unwilling or unable to provide informed consent (if needed per ethics committee).
研究组 & 干预措施
Patients with extra-pulmonary neuroendocrine carcinoma
Patients with Extrapulmonary Neuroendocrine Carcinoma (EP-NEC), diagnosed between August 2014 and August 2024.
干预措施: Observational study (Other)
Patients with pulmonary neuroendocrine carcinoma
Patients with Large-cell neuroendocrine carcinoma (LCNEC) or mixed and patients with Small Cell Lung Cancer (SCLC) or mixed, diagnosed between August 2014 and August 2024.
干预措施: Observational study (Other)
结局指标
主要结局
Patterns of Initial Cancer Treatment: number of participants treated within vs. outside high-volume sites and associated treatment characteristics
时间窗: Throughout the study period, an average of 24 months
Treatment patterns will be analyzed descriptively using tables and graphs to illustrate the distribution of patients receiving initial cancer treatment within versus outside high-volume treatment centers. Key characteristics of the initial treatment will be assessed.
Event-free survival (EFS)
时间窗: Throughout the study period, an average of 24 months
defined as time from diagnosis until relapse, death, or definitive failure of treatment strategy that implicates failure of curative-intent treatment \[for patients treated with curative intent\]. Participants who are lost to follow up or reach the study end will be censored at their last date of contact.
Time to treatment failure (TTF)
时间窗: Throughout the study period, an average of 24 months
in first and second-line: defined as time from first dose of treatments until date of discontinuation of treatment for any reason, including progression of disease, treatment toxicity, and death. Participants who are lost to follow up or reach the study end will be censored at their last date of contact
Progression-free survival (PFS)
时间窗: Throughout the study period, an average of 24 months
defined as time from treatment initiation until progression or death \[for patients treated with palliative intent\]. Participants who are lost to follow up or reach the study end will be censored at their last date of contact.
Overall survival
时间窗: Throughout the study period, an average of 24 months
\[according to disease stage/setting\], defined as time from initial diagnosis until date of death from any cause. Participants who are lost to follow up or reach the study end will be censored at their last date of contact.
Frequency of DLL-3 immunohistochemistry expression
时间窗: After the end of recruitment, an average of 1 year
Rate of patients with DLL3 expression in extra-pulmonary and pulmonary NEC by IHC \[stratified by tumor primary site\]
次要结局
未报告次要终点