Multicenter Retrospective Database on Prognostic and Predictive Factors in Patients With Neuroendocrine Tumors (LACOG/GTG 0119)

February 18, 2024 updated by: Latin American Cooperative Oncology Group
Multicenter retrospective longitudinal analytical study of patients with neuroendocrine tumors.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Hospital Alemão Oswaldo Cruz
      • São Paulo, Brazil
        • Fundacao Antonio Prudente - Ac Camargo Center
    • Bahia
      • Salvador, Bahia, Brazil
        • Ensino E Terapia de Inovacao Clinica Amo - Etica
    • Ceará
      • Fortaleza, Ceará, Brazil
        • Universidade Federal do Ceará/HOSPITAL UNIVERSITARIO WALTER CANTIDIO
    • Distrito Federal
      • Brasília, Distrito Federal, Brazil
        • Hospital Sirio Libanes Brasilia
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Hospital Moinhos de Vento
  • Peru
      • Surquillo, Peru
        • Instituto Nacional de Enfermedades Neoplasicas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18 years or older and with histologically confirmed neuroendocrine tumors; or metastatic or inoperable disease; or patients with clinical information about the therapies received, including exclusive palliative care.

Description

Inclusion Criteria:

  • Patients aged 18 years or older and with histologically confirmed neuroendocrine tumors;
  • Metastatic or inoperable disease;
  • Patients with clinical information about the therapies received, including exclusive palliative care.

Exclusion Criteria:

  • Lack of data on survival outcomes and/or details on treatments received.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients aged 18 years or older with histologically confirmed neuroendocrine tumor
Metastatic or inoperable disease; Patients with clinical information about the therapies received, including exclusive palliative care;
Other: Histologically confirmed neuroendocrine tumor
Patients aged 18 years or older with histologically confirmed neuroendocrine tumor of any grade or site; Metastatic or inoperable disease; Patients with clinical information about the therapies received, including exclusive palliative care;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2022
2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate per RECIST 1.1;
Time Frame: 2022
2022
Progression-free survival by RECIST 1.1 from D1 of each treatment;
Time Frame: 2022
2022
Symptom control time
Time Frame: 2022
Improvement of symptoms and/or stabilization of radiological disease in non-functioning ENT, at the physician's discretion
2022
Incidence of complications of the disease and/or treatments, defined by adverse events
Time Frame: 2022
2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Latin American Cooperative Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2020

Primary Completion (Actual)

June 30, 2023

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

December 22, 2021

First Posted (Actual)

December 23, 2021

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LACOG 0119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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