Clinical trial NCT03658928: A Non-interventional Retrospective Study on Overall Survival in Completely Resected Chinese NSCLC Patients With Adenocarcinoma Histology- ICAN Extension Study
Official title: Guangdong Association of Clinical Trials
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overall Survival
Lead sponsor: Guangdong Association of Clinical Trials
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 571
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: It is a non-interventional, retrospective study and all the patients participated in ICAN study will be enrolled.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Patients ≥18 years old.
2. Provision of informed consent prior to any study specific procedures
3. Histological diagnosed as adenocarcinoma type of non-small cell lung cancer
4. Have completed lung cancer operation
5. The tumour EGFR gene mutation status test was performed as regular medical practice

Exclusion Criteria:

1. No provision of informed consent or EC approve informed consent waiver prior to any study specific procedures;
2. Patients withdrew consent for ICAN study;
3. Patients in whose medical record was objected to use the existing data for scientific research

Primary outcomes:
measure: Overall survival
timeFrame: from the date of operation to date of death from any cause, whichever came first, assessed up to 8 years.
Secondary outcomes:
measure: Disease free survival
timeFrame: •from operation until recurrence of tumor or death from any cause, whichever came first, assessed up to 8 years.
Other outcomes:
Locations:
Study officials:
References: