Retrospective Epidemiological Study of Locally Advanced Non Small Cell Lung Cancer Patients in Brazil (RELANCE)

February 18, 2024 updated by: Latin American Cooperative Oncology Group
RELANCE is a large multi-institutional study that aims to retrospectively collect information about diagnostic, treatment and outcome of patients diagnosed with locally advanced NSCLC in Brazil. It is hypothesized that there is a great heterogeneity in treatment patterns owing to inequities in access to adequate staging methods, optimal treatment and multidisciplinary teams in Brazil.

Study Overview

Status

Completed

Conditions

Detailed Description

RELANCE study will collect sociodemographic and clinical data of patients diagnosed with locally advanced NSCLC in the period of January 2015 and Jun 2019 in the participating institutions. Socio-demographic characteristics, clinicopathological features, treatments patterns and outcomes will be recovered from medical charts. Disease status and survival data will be collected up to the last date of follow-up June 2021.

Study Type

Observational

Enrollment (Actual)

403

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
    • SP
      • São Paulo, SP, Brazil
        • AC Camargo

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 diagnosed with stage IIIA or IIIB NSCLC in the period of January 2015 to December 2016.

Description

Inclusion Criteria:

  1. Patients aged 18 years or older;
  2. Histologically or cytological diagnosis of NSCLC in the period of January 2015 to December 2016;
  3. Locally Advanced NSCLC defined as clinical stage IIIA and IIIB according to 7th Edition TNM Staging System;
  4. Any NSCLC histological subtype and molecular mutation;
  5. Any Eastern Cooperative Oncology Group (ECOG) Performance Status (0 to 4) at diagnosis;
  6. Patients assigned by treating physician to any therapy or palliative care;
  7. Access to patient medical chart for data collection.

Exclusion Criteria:

  1. Small cell lung cancer and non-invasive NSCLC;
  2. Synchronic NSCLC or second primary tumour in the last 5 years (except non-melanoma skin cancer).

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Up to June 30, 2018
defined as time from diagnosis to death of any cause;
Up to June 30, 2018

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: Up to June 30, 2018
defined as time from any line of treatment to progression of the disease or death of any cause
Up to June 30, 2018
Time to next treatment
Time Frame: Up to June 30, 2018
defined as time from start of the any treatment to the beginning of a second therapy
Up to June 30, 2018

Collaborators and Investigators

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

Sponsor

Latin American Cooperative Oncology Group

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Vladmir Cláudio Cordeiro de Lima, 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)

September 25, 2019

Primary Completion (Actual)

June 9, 2022

Study Completion (Actual)

June 9, 2022

Study Registration Dates

First Submitted

February 8, 2019

First Submitted That Met QC Criteria

February 8, 2019

First Posted (Actual)

February 11, 2019

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LACOG 0118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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