Lung Cancer, Non-small CellRELANCENCT03836469
Retrospective Epidemiological Study of Locally Advanced Non Small Cell Lung Cancer Patients in Brazil
An observational study of Lung Cancer, Non-small Cell, run by Latin American Cooperative Oncology Group at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-small Cell
- How many people
- 403 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Sep 2019to 9 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 diagnosed with stage IIIA or IIIB NSCLC in the period of January 2015 to December 2016.
Who may be able to join
- Patients aged 18 years or older;
- Histologically or cytological diagnosis of NSCLC in the period of January 2015 to December 2016;
- Locally Advanced NSCLC defined as clinical stage IIIA and IIIB according to 7th Edition TNM Staging System;
- Any NSCLC histological subtype and molecular mutation;
- Any Eastern Cooperative Oncology Group (ECOG) Performance Status (0 to 4) at diagnosis;
- Patients assigned by treating physician to any therapy or palliative care;
- Access to patient medical chart for data collection.
Who cannot join
- Small cell lung cancer and non-invasive NSCLC;
- Synchronic NSCLC or second primary tumour in the last 5 years (except non-melanoma skin cancer).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Lung Cancer, Non-small Cell
- Keywords
- Lung cancer, Non-small cell
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
defined as time from diagnosis to death of any cause;
Measured: Up to June 30, 2018
Secondary outcomes (2)
Progression free survival
defined as time from any line of treatment to progression of the disease or death of any cause
Measured: Up to June 30, 2018
Time to next treatment
defined as time from start of the any treatment to the beginning of a second therapy
Measured: Up to June 30, 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start25 Sep 2019
- Primary completion9 Jun 2022
- Study completion9 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Non-small CellStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Vladmir Cláudio Cordeiro de Lima, Principal investigator, Latin American Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836469
- Sponsor's protocol ID
- LACOG 0118
- Acronym
- RELANCE
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2019
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Epidemiological Study of Locally Advanced Non Small Cell Lung Cancer Patients in Brazil
- ClinicalTrials.gov ID
- NCT03836469
- Acronym / sponsor ID
- RELANCE / LACOG 0118
- Conditions
- Lung Cancer, Non-small Cell
- Keywords
- Lung cancer, Non-small cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 11 Feb 2019 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with stage IIIA or IIIB NSCLC in the period of January 2015 to December 2016.
Key inclusion criteria (7 listed)
- Patients aged 18 years or older;
- Histologically or cytological diagnosis of NSCLC in the period of January 2015 to December 2016;
- Locally Advanced NSCLC defined as clinical stage IIIA and IIIB according to 7th Edition TNM Staging System;
- Any NSCLC histological subtype and molecular mutation;
- Any Eastern Cooperative Oncology Group (ECOG) Performance Status (0 to 4) at diagnosis;
Key exclusion criteria (2 listed)
- Small cell lung cancer and non-invasive NSCLC;
- Synchronic NSCLC or second primary tumour in the last 5 years (except non-melanoma skin cancer).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: Up to June 30, 2018
defined as time from diagnosis to death of any cause;
2 secondary outcomes
Progression free survival
Time frame: Up to June 30, 2018
Time to next treatment
Time frame: Up to June 30, 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Vladmir Cláudio Cordeiro de Lima principal investigator
Latin American Cooperative Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, Non-small Cell, run by Latin American Cooperative Oncology Group at 1 site in Brazil.
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: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Up to June 30, 2018). 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 20 Feb 2024.