A Non-interventional Retrospective Study on Overall Survival in Completely Resected Chinese NSCLC Patients With Adenocarcinoma Histology- ICAN Extension Study

NCT03658928 | Unknown

• 1 other identifier: CTONG1802
• Study Type: observational
• Target: 571
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overall Survival

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  •from operation until recurrence of tumor or death from any cause, whichever came first, assessed up to 8 years.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

It is a non-interventional, retrospective study and all the patients participated in ICAN study will be enrolled.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Association of Clinical Trials: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 6, 2018
• Study Start: August 31, 2018
• Primary Completion: January 31, 2019
• Study Completion: April 30, 2019
• Last Updated: September 6, 2018

Record last verified: 2018-03