Neuroendocrine CarcinomasNECTARINENCT07192991
Neuroendocrine Carcinomas: Patient Journey And Treatment Outcomes In Latin America
An observational study of Neuroendocrine Carcinomas and Lung Neuroendocrine Carcinoma, run by Latin American Cooperative Oncology Group at 19 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Carcinomas, Lung Neuroendocrine Carcinoma
- What is being tested?
- Observational study
- How many people
- 200 participants
- Where
- 19 sitesin 4 countries
- Study dates
- 16 Dec 2025to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥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
Who cannot join
- 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).
Trial locations and contacts
19 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 4 countries
Brazil13 sites
- Active, not recruiting
Oncocentro de Minas Gerais (Oncoclínicas)
Belo Horizonte, Minas Gerais, 30360-680
- Active, not recruiting
Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)
Cachoeiro de Itapemirim, Espírito Santo, 29308-065
- Active, not recruiting
Clínica Prognóstica - Centro de Pesquisa Clínica Onconeo
Campo Grande, Mato Grosso do Sul, 79002-061
- Active, not recruiting
IOP Pesquisa - Instituto de Oncologia do Paraná
Curitiba, Paraná, 80040-170
- Active, not recruiting
ANIMI - Unidade de Tratamento Oncológico
Lages, Santa Catarina, 88501-001
- Active, not recruiting
HCL - Hospital do Câncer de Londrina
Londrina, Paraná, 86015-520
- Active, not recruiting
HUOL - Hospital Universitário Onofre Lopes da UFRN
Natal, Rio Grande do Norte, 59012-300
- Active, not recruiting
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59062-000
- Active, not recruiting
HMV - Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-001
- Active, not recruiting
Futtura Oncologia - Hub de Pesquisa Clínica
Porto Alegre, Rio Grande do Sul, 90470-340
- Active, not recruiting
INCA - Instituto Nacional de Câncer
Rio de Janeiro, Rio de Janeiro, 20230-130
- Active, not recruiting
A.C. Camargo Cancer Center
São Paulo, São Paulo, 01509-001
- Active, not recruiting
HIAE - Hospital Israelita Albert Einstein
São Paulo, São Paulo
Argentina3 sites, 3 recruiting
- Recruiting
Hospital Británico de Buenos Aires
Buenos Aires, Buenos Aires
Ernesto Korbenfeld
- Recruiting
Hospital de Gastroenterología Carlos Bonorino Udaondo
Buenos Aires, Buenos Aires
Andrea Elizabeth Acosta
- Recruiting
Instituto Alexander Fleming
Buenos Aires, Buenos Aires
Claudio Marcelo Martin
Mexico2 sites
- Active, not recruiting
Centro Oncológico Internacional (COI)
Mexico City, Mexico City
- Active, not recruiting
INCan - Instituto Nacional de Cancerología
Mexico City, Mexico City
Peru1 site, 1 recruiting
- Recruiting
Oncosalud AUNA
Lima, Lima Province
Paola Catherine Montenegro Beltràn
About this study
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.
Read the detailed description
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.
- Being tested
- Observational study
- Medical subject headings
- Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Patients with extra-pulmonary neuroendocrine carcinoma | Patients with Extrapulmonary Neuroendocrine Carcinoma (EP-NEC), diagnosed between August 2014 and August 2024. Receives: 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. Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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]
Measured: After the end of recruitment, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start16 Dec 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine CarcinomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim, Grupo Argentino de Investigación Clínica en Oncología, Grupo de Estudios Clínicos Oncológicos Peruano
- Responsible party
- Sponsor
- Investigators
- Rachel Simões Pimenta Riechelmann, Principal investigator, Latin American Cooperative Oncology GroupVladmir Cláudio Cordeiro de Lima, Principal investigator, Latin American Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192991
- Sponsor's protocol ID
- LACOG 1324
- Acronym
- NECTARINE
- Status last verified
- Aug 2026
- First submitted
- 17 Feb 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroendocrine Carcinomas: Patient Journey And Treatment Outcomes In Latin America
- ClinicalTrials.gov ID
- NCT07192991
- Acronym / sponsor ID
- NECTARINE / LACOG 1324
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim, Grupo Argentino de Investigación Clínica en Oncología, Grupo de Estudios Clínicos Oncológicos Peruano
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with extra-pulmonary neuroendocrine carcinoma | – | Other: Observational studyPatients with Extrapulmonary Neuroendocrine Carcinoma (EP-NEC), diagnosed between August 2014 and August 2024. |
| Patients with pulmonary neuroendocrine carcinoma | – | Other: Observational studyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- ≥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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyThis is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care. | Other | Patients with extra-pulmonary neuroendocrine carcinoma, Patients with pulmonary neuroendocrine carcinoma |
Primary outcome
Patterns of Initial Cancer Treatment: number of participants treated within vs. outside high-volume sites and associated treatment characteristics
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Simões Pimenta Riechelmann principal investigator
Latin American Cooperative Oncology Group
Vladmir Cláudio Cordeiro de Lima principal investigator
Latin American Cooperative Oncology Group
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Carcinomas and Lung Neuroendocrine Carcinoma, run by Latin American Cooperative Oncology Group at 19 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Brazil, Argentina, Mexico, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Manager (+55 51 3384 5334, lacog1324@lacog.group), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patterns of Initial Cancer Treatment: number of participants treated within vs. outside high-volume sites and associated treatment characteristics (time frame: Throughout the study period, an average of 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.