The Molecular Screening Study for the Umbrella Trial (SUKSES) in Relapsed Small Cell Lung Cancer Patients [SUKSES-S]

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

This protocol is a molecular screening protocol only. No drug intervention study will be included in this protocol. Based on the molecular profiling, patients may be eligible for drug intervention study of SUKSES trial. This procedure can be performed during or after the first-line treatment. DNA will be extracted from the archived or fresh tissue and blood. NGS-based cancer panel and Nanostring CNV will be tested with DNA from tissue and/or blood. Immunohistochemistry and FISH will be done by pathologists using archived or fresh tissue. Tumor tissues (fresh or archival) will be analyzed using NGS-based cancer panel, nanostring CNV, immunohistochemistry and/or FISH. Specific methods of each molecular tests will be defined with standard laboratory manual developed by pathologists.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• Provision of fully informed consent prior to any study specific procedures.

• Patients must be ≥20 years of age.

• Histologically or cytologically confirmed Small cell lung cancers

• ECOG performance status of 0 to 2

• Patients who are being treated or were treated with platinum-based chemotherapy as a first-line treatment

• Patients with available archival tissues for molecular analysis or patients who agreed with biopsy for molecular analysis

Locations
Other Locations
Republic of Korea
Gachon University Gil Medical Center
COMPLETED
Incheon
Chungbuk University Hospital
COMPLETED
Jungbuk
Seoul National University Bundang Hospital
COMPLETED
Seongnam
Samsung Medical Center
RECRUITING
Seoul
VHS Medical Center
COMPLETED
Seoul
Ulsan University Hospital
COMPLETED
Ulsan
Contact Information
Primary
Se-Hoon Lee, MD,Ph.D.
sehoon.lee@samsung.com
+82-10-4759-7640
Backup
Seoha Kim
seoha88.kim@samsung.com
+82-2-2148-7668
Time Frame
Start Date: 2016-04-29
Estimated Completion Date: 2024-12
Participants
Target number of participants: 797
Treatments
Small cell lung cancers
To provide molecular characteristics of Small cell lung cancers to proceed SUKSES trial, To assess success rate of molecular profiling of Small cell lung cancers
Sponsors
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov