Liquid BiOpsy, Lung and Colon Cancer in AndaluciA

Condition(s) studied

Investigational drug(s) / intervention(s)

xF Tempus assay: The blood will be collected and sent to Tempus Labs using the standard sample collection kit containing all the necessary elements to guarantee shipment to Tempus Labs. Two Streck tubes with 8.5mL of blood per tube will be sent to Tempus Labs. The ctDNA isolation and automatic library preparation will be performed using TEMPUS technology (Finkel et al 2021). The NGS analyses will be developed using the xF Tempus assay. This assay involves a panel with hybrid gene capture that detects actionable oncologic targets in four variant classes: single-nucleotide variants (SNVs), insertions/deletions (indels), copy number variants (CNVs), and gene rearrangements. The NGS sequencing is performed using NovaSeq 6000Dx Sequencing System (Illumina, Inc) equipment, according to Tempus protocols. (Finkel et al 2021).

Study summary

The objective of the LOLA Project is to analyse the impact of adopting xF liquid biopsy panel, in the real world of the Andalusian Health Public System in terms of impact on clinical practice and cost through the assessment of clinical impact, duration of turnaround time (TAT) of xF test vs standard of care and the analysis of resource utilisation.

Eligibility

Primary outcome measure(s)

• To analyse the impact of adopting large (TEMPUS) NGS panels in the real world of the Andalusian Health Public System in terms of impact on clinical practice and cost. — through study completion, an average of 3 year
  Proportion of patients with at least one actionable variant (%)

Trial sites (1)

More Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental trials in Spain

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