NCT07192991

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
4 countries

19 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2025

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 25, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

December 16, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Completed
Last Updated

September 8, 2026

Status Verified

August 1, 2026

Enrollment Period

9 months

First QC Date

February 17, 2025

Last Update Submit

September 2, 2026

Conditions

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

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 carcinomaPatients with pulmonary neuroendocrine carcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Hospital Británico de Buenos Aires

Buenos Aires, Buenos Aires, Argentina

RECRUITING

Hospital de Gastroenterología Carlos Bonorino Udaondo

Buenos Aires, Buenos Aires, Argentina

RECRUITING

Instituto Alexander Fleming

Buenos Aires, Buenos Aires, Argentina

RECRUITING

Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)

Cachoeiro de Itapemirim, Espírito Santo, 29308-065, Brazil

ACTIVE NOT RECRUITING

Clínica Prognóstica - Centro de Pesquisa Clínica Onconeo

Campo Grande, Mato Grosso do Sul, 79002-061, Brazil

ACTIVE NOT RECRUITING

Oncocentro de Minas Gerais (Oncoclínicas)

Belo Horizonte, Minas Gerais, 30360-680, Brazil

ACTIVE NOT RECRUITING

IOP Pesquisa - Instituto de Oncologia do Paraná

Curitiba, Paraná, 80040-170, Brazil

ACTIVE NOT RECRUITING

HCL - Hospital do Câncer de Londrina

Londrina, Paraná, 86015-520, Brazil

ACTIVE NOT RECRUITING

INCA - Instituto Nacional de Câncer

Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil

ACTIVE NOT RECRUITING

HUOL - Hospital Universitário Onofre Lopes da UFRN

Natal, Rio Grande do Norte, 59012-300, Brazil

ACTIVE NOT RECRUITING

Liga Norte Riograndense Contra o Câncer

Natal, Rio Grande do Norte, 59062-000, Brazil

ACTIVE NOT RECRUITING

HMV - Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

ACTIVE NOT RECRUITING

Futtura Oncologia - Hub de Pesquisa Clínica

Porto Alegre, Rio Grande do Sul, 90470-340, Brazil

ACTIVE NOT RECRUITING

ANIMI - Unidade de Tratamento Oncológico

Lages, Santa Catarina, 88501-001, Brazil

ACTIVE NOT RECRUITING

A.C. Camargo Cancer Center

São Paulo, São Paulo, 01509-001, Brazil

ACTIVE NOT RECRUITING

HIAE - Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

ACTIVE NOT RECRUITING

Centro Oncológico Internacional (COI)

Mexico City, Mexico City, Mexico

ACTIVE NOT RECRUITING

INCan - Instituto Nacional de Cancerología

Mexico City, Mexico City, Mexico

ACTIVE NOT RECRUITING

Oncosalud AUNA

Lima, Lima Province, Peru

RECRUITING

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 TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

MethodsInvestigative 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

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

December 16, 2025

Primary Completion

September 1, 2026

Study Completion

September 1, 2026

Last Updated

September 8, 2026

Record last verified: 2026-08

Locations