Neuroendocrine Carcinomas: Patient Journey And Treatment Outcomes In Latin America

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Observational study
  This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.

Первичные конечные точки

• Patterns of Initial Cancer Treatment: number of participants treated within vs. outside high-volume sites and associated treatment characteristics [Срок оценки: Throughout the study period, an average of 24 months]
• Event-free survival (EFS) [Срок оценки: Throughout the study period, an average of 24 months]
• Time to treatment failure (TTF) [Срок оценки: Throughout the study period, an average of 24 months]
• Progression-free survival (PFS) [Срок оценки: Throughout the study period, an average of 24 months]
• Overall survival [Срок оценки: Throughout the study period, an average of 24 months]
• Frequency of DLL-3 immunohistochemistry expression [Срок оценки: After the end of recruitment, an average of 1 year]

Критерии участия

Критерии включения

• ≥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

Критерии исключения

• 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).

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07192991 · LACOG 1324

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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