Overall SurvivalNCT03658928
A Non-interventional Retrospective Study on Overall Survival in Completely Resected Chinese NSCLC Patients With Adenocarcinoma Histology- ICAN Extension Study
An observational study of Overall Survival, run by Guangdong Association of Clinical Trials.
Trial summary
ICAN was a non-interventional study to explore the EGFR gene mutation status, clinical outcome and recurrent risk factors in early stage Chinese NSCLC with adenocarcinoma histology after complete resection (NIS-OCN-DUM-2009/1). The study had enrolled 571 patients from Apr. 2010 to Dec. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overall Survival
- How many people
- 571 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2018to 30 Apr 2019
- 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: It is a non-interventional, retrospective study and all the patients participated in ICAN study will be enrolled.
Who may be able to join
- Patients ≥18 years old.
- Provision of informed consent prior to any study specific procedures
- Histological diagnosed as adenocarcinoma type of non-small cell lung cancer
- Have completed lung cancer operation
- The tumour EGFR gene mutation status test was performed as regular medical practice
Who cannot join
- No provision of informed consent or EC approve informed consent waiver prior to any study specific procedures;
- Patients withdrew consent for ICAN study;
- Patients in whose medical record was objected to use the existing data for scientific research
About this study
Official title: Guangdong Association of Clinical Trials
ICAN was a non-interventional study to explore the EGFR gene mutation status, clinical outcome and recurrent risk factors in early stage Chinese NSCLC with adenocarcinoma histology after complete resection (NIS-OCN-DUM-2009/1). The study had enrolled 571 patients from Apr. 2010 to Dec. 2010 in 24 sites located in the mainland of China. The study had completed and major results showed that EGFR mutation rate was 55.1% and 3-year DFS rate was 61.7% in early stage Chinese NSCLC with adenocarcinoma histology after complete resection. Postoperative pathologic stage, gender, surgical and resection types had a statistically significant association with 3-year DFS.
This study is ICAN extension study with the purpose to collect the overall survival data from previous ICAN study. Approximately 571 patients who participated in ICAN study will be enrolled.
Read the detailed description
Primary objective
- To observe the overall survival of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study.
Secondary objectives
- To observe the updated DFS of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study;
- To observe the treatment pattern after tumor recurrence of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study in real-world setting;
- To explore the risk factors of OS for early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study in real-world setting, such as EGFR mutation status, gender, smoking history, treatment pattern after recurrence, etc.
- Conditions
- Overall Survival
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
is defined as the time from the date of operation to date of death. For patients who are still alive, the last date when the patient is known to be alive will be used to determine the censoring date.
Measured: from the date of operation to date of death from any cause, whichever came first, assessed up to 8 years.
Secondary outcomes (1)
Disease free survival
is defined as the time from operation until recurrence of tumor or death from any cause, whichever occurs first.
Measured: •from operation until recurrence of tumor or death from any cause, whichever came first, assessed up to 8 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start31 Aug 2018 (estimated)
- Primary completion31 Jan 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overall SurvivalStudies 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
- 571 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658928
- Sponsor's protocol ID
- CTONG1802
- Status last verified
- Mar 2018
- First submitted
- 31 Aug 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guangdong Association of Clinical Trials
- ClinicalTrials.gov ID
- NCT03658928
- Acronym / sponsor ID
- CTONG1802
- Conditions
- Overall Survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 571 participants (estimated)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Study start
- 31 Aug 2018 (estimated)
- Primary completion
- 31 Jan 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 6 Sep 2018 (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.
ICAN was a non-interventional study to explore the EGFR gene mutation status, clinical outcome and recurrent risk factors in early stage Chinese NSCLC with adenocarcinoma histology after complete resection (NIS-OCN-DUM-2009/1). The study had enrolled 571 patients from Apr. 2010 to Dec. 2010 in 24 sites located in the mainland of China. The study had completed and major results showed that EGFR mutation rate was 55.1% and 3-year DFS rate was 61.7% in early stage Chinese NSCLC with adenocarcinoma histology after complete resection. Postoperative pathologic stage, gender, surgical and resection types had a statistically significant association with 3-year DFS.
This study is ICAN extension study with the purpose to collect the overall survival data from previous ICAN study. Approximately 571 patients who participated in ICAN study will be enrolled.
Detailed description
Primary objective
- To observe the overall survival of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study.
Secondary objectives
- To observe the updated DFS of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study;
- To observe the treatment pattern after tumor recurrence of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study in real-world setting;
- To explore the risk factors of OS for early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study in real-world setting, such as EGFR mutation status, gender, smoking history, treatment pattern after recurrence, etc.
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
- It is a non-interventional, retrospective study and all the patients participated in ICAN study will be enrolled.
Key inclusion criteria (5 listed)
- Patients ≥18 years old.
- Provision of informed consent prior to any study specific procedures
- Histological diagnosed as adenocarcinoma type of non-small cell lung cancer
- Have completed lung cancer operation
- The tumour EGFR gene mutation status test was performed as regular medical practice
Key exclusion criteria (3 listed)
- No provision of informed consent or EC approve informed consent waiver prior to any study specific procedures;
- Patients withdrew consent for ICAN study;
- Patients in whose medical record was objected to use the existing data for scientific research
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: from the date of operation to date of death from any cause, whichever came first, assessed up to 8 years.
is defined as the time from the date of operation to date of death. For patients who are still alive, the last date when the patient is known to be alive will be used to determine the censoring date.
1 secondary outcome
Disease free survival
Time frame: •from operation until recurrence of tumor or death from any cause, whichever came first, assessed up to 8 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Overall Survival, run by Guangdong Association of Clinical Trials.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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: from the date of operation to date of death from any cause, whichever came first, assessed up to 8 years.). 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 6 Sep 2018.