The Molecular Screening Study for the Umbrella Trial (SUKSES) in Relapsed Small Cell Lung Cancer Patients [SUKSES-S]
1 other identifier
observational
797
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2016
CompletedFirst Posted
Study publicly available on registry
February 23, 2016
CompletedStudy Start
First participant enrolled
April 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
April 28, 2026
April 1, 2026
12.4 years
February 18, 2016
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Ratio of each molecular subtypes
To provide molecular characteristics of SCLC to proceed SUKSES trial
After registration of this study
Secondary Outcomes (1)
Success rate of each molecular profiling methods
After completion of registration
Study Arms (1)
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
Interventions
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 Criteria
Histologically or cytologically confirmed Small cell lung cancers
You may qualify if:
- 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
You may not qualify if:
- More than two prior chemotherapy regimen for the treatment of small cell lung cancer
- Pregnant or nursing women (women of reproductive potential have to agree to use an effective contraceptive method)
- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤2 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Gachon University Gil Medical Center
Incheon, South Korea
Chungbuk University Hospital
Jungbuk, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
VHS Medical Center
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
Biospecimen
Tumor tissue, whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Se-Hoon Lee, MD, PhD
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD,PhD
Study Record Dates
First Submitted
February 18, 2016
First Posted
February 23, 2016
Study Start
April 29, 2016
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
April 28, 2026
Record last verified: 2026-04