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

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Samsung Medical Center

Status

Enrolling

Conditions

Small Cell Lung Cancers
Neuroendocrine Carcinoma

Treatments

Other: No treatment is included in this protocol.

Study type

Observational

Funder types

Other

Identifiers

NCT02688894
2016-02-071

Details and patient eligibility

About

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.

Full description

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 (molecular profiling) can be performed before, during, or after the initial 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. In addition, blood collection will be conducted at Baseline (initial), three weeks, six weeks, twelve weeks, and subsequent imaging. 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.

Enrollment

797 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. Histologically or cytologically confirmed Small cell lung cancers
  4. ECOG performance status of 0 to 2
  5. Patients who are being treated or were treated with platinum-based chemotherapy as a first-line treatment
  6. Patients with available archival tissues for molecular analysis or patients who agreed with biopsy for molecular analysis

Exclusion criteria

  1. More than two prior chemotherapy regimen for the treatment of small cell lung cancer
  2. Pregnant or nursing women (women of reproductive potential have to agree to use an effective contraceptive method)
  3. 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.

Trial design

797 participants in 1 patient group

Small cell lung cancers
Description:
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
Treatment:
Other: No treatment is included in this protocol.

Trial contacts and locations

6

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Central trial contact

Seoha Kim; Se-Hoon Lee, MD,Ph.D.

Data sourced from clinicaltrials.gov

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