A Multicenter Retrospective Observational Study to Investigate the Epidemiology and Recurrence and Prognosis in Patients Undergoing Surgery for Lung Adenocarcinoma Harboring ALK Rearrangement

JRCT ID: jRCT1050240057

Registered date:10/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Lung adenocarcinoma
• Date of first enrollment: 10/06/2024
• Target sample size: 950
• Study type: Observational

Outcome(s)

• Primary Outcome: Prevalence of ALK fusion gene

Secondary Outcome

- Patient characteristics of ALK-positive and negative populations
- Relapse free survival (RFS)
- Overall survival (OS)
- Type and site of recurrence
- Post recurrence progression free survival
- Post recurrence survival

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Among patients who have undergone surgery with curative intent between January 2010 and December 2019 at the Department of Thoracic Surgery at Kindai University Hospital or each participating institution, those who have been diagnosed with primary lung adenocarcinoma based on pathological diagnosis.
2) Pathological stage IIA, IIB, IIIA. (UICC version - 8)
3) Patients with known ALK status in clinical practice. Or, if ALK status is unknown, the subject must be able to provide a specimen (at least 4 unstained slides (4 um thick)) for ALK testing. (If ALK Status is known, patients may be enrolled even if they cannot submit samples for ALK testing. Regardless of the method of ALK testing in actual clinical settings)

Exclude criteria

1) Refused participation in the study
2) Other subjects judged to be inappropriate by the principal investigator

Related Information

• Primary Sponsor: Tsutani Yasuhiro
• Secondary Sponsor: Chugai Pharmaceutical Co.,LTD