Neuroendocrine Carcinomas: Patient Journey And Treatment Outcomes In Latin America

NCT07192991 | Not Yet Recruiting

• 1 other identifier: LACOG 1324
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neuroendocrine Carcinomas; Lung Neuroendocrine Carcinoma

Outcome Measures

Primary Outcomes (6)

• Patterns of Initial Cancer Treatment: number of participants treated within vs. outside high-volume sites and associated treatment characteristics

  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.

  Throughout the study period, an average of 24 months

• Event-free survival (EFS)

  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.

  Throughout the study period, an average of 24 months

• Time to treatment failure (TTF)

  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

  Throughout the study period, an average of 24 months

• Progression-free survival (PFS)

  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.

  Throughout the study period, an average of 24 months

• Overall survival

  \[according to disease stage/setting\], 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.

  Throughout the study period, an average of 24 months

• Frequency of DLL-3 immunohistochemistry expression

  Rate of patients with DLL3 expression in extra-pulmonary and pulmonary NEC by IHC \[stratified by tumor primary site\]

  After the end of recruitment, an average of 1 year

Study Arms (2)

Patients with extra-pulmonary neuroendocrine carcinoma

Patients with Extrapulmonary Neuroendocrine Carcinoma (EP-NEC), diagnosed between August 2014 and August 2024.

Other: Observational study

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.

Other: Observational study

Interventions

Observational study OTHER

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

Patients with extra-pulmonary neuroendocrine carcinoma; Patients with pulmonary neuroendocrine carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with extra-pulmonary neuroendocrine carcinoma (EP-NEC) and patients with pulmonary neuroendocrine carcinoma (SCLC or LCNEC) from Brazil, Mexico, Argentina and Peru.

You may qualify if:

• ≥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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Latin American Cooperative Oncology Group: lead
• Boehringer Ingelheim: collaborator
• Grupo Argentino de Investigación Clínica en Oncología: collaborator
• Grupo de Estudios Clínicos Oncológicos Peruano: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tumor block: Formalin-Fixed Paraffin-Embedded collected from 2014 onwards.

MeSH Terms

Conditions

Carcinoma, Neuroendocrine

Interventions

Observation

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Rachel Simões Pimenta Riechelmann

  Latin American Cooperative Oncology Group

  PRINCIPAL INVESTIGATOR

• Vladmir Cláudio Cordeiro de Lima

  Latin American Cooperative Oncology Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Manager

CONTACT

+55 51 3384 5334; lacog1324@lacog.group

Laura Voelcker

CONTACT

+55 51 3384 5334; laura.voelcker@lacog.group

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: September 25, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09