Clinical trial · Observational
Concordance of Inivata Liquid Biopsy With Standard Tissue Biopsy
An Observational Multicenter Study to Evaluate the Performance and Utility of Inivata Liquid Biopsy Analysis Compared With Tissue Biopsy Analysis for Detection of Genomic Alterations in Patients With Lung Cancer
NCT03116633CI-TRIAL-00038659completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to look at a comparison of liquid biopsy (blood sample) analysis compared with tissue biopsy in patients with advanced lung cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Arm A
- description
- 1st line setting-approx. 150 patients. collect tissue biopsy per standard of care \& one blood draw (40ml)
- label
- Arm B
- description
- 1st line setting- approx. 100 patients one blood draw (40ml)
- label
- Arm C
- description
- Approx. 10 patients tissue collection optional 3 blood draws (40ml) over 5 days
Primary outcomes (1)
- measure
- Concordance in the detection of molecular abnormalities using Inivata liquid biopsy panel with detection using standard of care tissue biopsy analysis.
- timeFrame
- 12 months
- description
- The primary endpoint is concordance in detecting molecular abnormalities using Inivata liquid biopsy panel compared with detection using tissue biopsy analysis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written, signed and dated informed consent * Male \& female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC. * Patients intended to initiate first-line treatment (Arms A and B) * Patients who plan to have or have had a recent tumor tissue biopsy taken as part of their standard of care (Arm A) * Patient must understand and be able, willing and likely to fully comply with all study procedures and restrictions. Exclusion Criteria: * Patients who have received any approved or experimental cancer therapy since their most recent NSCLC tissue biopsy * Any history of metastatic cancer. * Previous malignancy in the last 2 years (except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix). * Patient with a severe acute or chronic medical or psychiatric condition or laboratory abnormality
References
Publications (0)
Data not yet available
No reference posted for this study.