Status:
COMPLETED
Spanish Lung Liquid vs. Invasive Biopsy Program (SLLIP)
Lead Sponsor:
MedSIR
Collaborating Sponsors:
Guardant Health, Inc.
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
Tumor Derived cell free DNA (cfDNA) is increasingly used in the clinic to obtain genotype information about lung cancer, but its concordance with concurrent tumor-derived sequenced data is not known. ...
Detailed Description
Primary objective: To demonstrate the non-inferiority of cfDNA-based versus tumor tissue-based genotyping as it pertains to the detection of clinically-actionable biomarkers in first line, treatment ...
Eligibility Criteria
Inclusion
- Patients biopsy-proven, metastatic, previously untreated, non-squamous non-small cell lung cancer (NSCLC). Patients may have received adjuvant cytotoxic chemotherapy, but not targeted neo-adjuvant or adjuvant therapy.
- Age ≥ 18 years
- Ability to understand a written informed consent document, and the willingness to sign it.
- Willingness to provide blood sample at the time points defined in Table 1 \[pre-treatment, Day 14 (+/- 7 days) and End of Study\].
- Patient has or will have standard-of-care tissue genotyping ordered.
- Stable Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Exclusion
- Pregnancy, recorded from clinical records
- Any concurrent, non-cutaneous, malignancy (with the exception of early stage non-invasive cervical cancer). Any prior cancer must have occurred more than 5 years prior with no evidence of currently active disease
Key Trial Info
Start Date :
July 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT03248089
Start Date
July 1 2016
End Date
January 1 2019
Last Update
January 9 2019
Active Locations (7)
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1
H. Can Ruti
Badalona, Spain
2
Dexeus
Barcelona, Spain
3
H. del Mar
Barcelona, Spain
4
H. Sant Pau
Barcelona, Spain