Skip to content

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

A Multicenter Retrospective Observational Study to Investigate the Epidemiology and Recurrence and Prognosis in Patients Undergoing Surgery for Lung Adenocarcinoma Harboring ALK Rearrangement - CReGYT-03 ALK study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1050240057
Enrollment
950
Registered
2024-06-10
Start date
2024-06-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung adenocarcinoma Lung adenocarcinoma

Interventions

None listed

Sponsors

Tsutani Yasuhiro
Lead Sponsor
Chugai Pharmaceutical Co.,LTD
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Prevalence of ALK fusion gene

Secondary

MeasureTime frame
- 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

Contacts

Public ContactAkira Hamada

Kindai University

a-hamada@med.kindai.ac.jp+81-72-366-0221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026