Neuroendocrine Carcinomas: Patient Journey And Treatment Outcomes In Latin America

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- ≥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.

Exclusion Criteria:

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07192991
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Latin American Cooperative Oncology Group
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Rachel Simões Pimenta RiechelmannVladmir Cláudio Cordeiro de Lima
Principal Investigator Affiliation	Latin American Cooperative Oncology GroupLatin American Cooperative Oncology Group
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroendocrine Carcinomas, Lung Neuroendocrine Carcinoma

Additional Details

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.#46;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.

Arms & Interventions

Arms

: Patients with extra-pulmonary neuroendocrine carcinoma

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

: 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.

Interventions

Other: - Observational study

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Project Manager

[email protected]

+55 51 3384 5334

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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