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Liquid BiOpsy, Lung and Colon Cancer in AndaluciA

NCT06997458 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-05-30

No results posted yet for this 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.

Conditions

  • Non Small Cell Lung Cancer (NSCLC)
  • Colorectal Cancer (CRC)

Interventions

DIAGNOSTIC_TEST

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).

Sponsors & Collaborators

  • Tempus AI

    collaborator INDUSTRY

  • Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

    lead OTHER

Principal Investigators

  • M Jose Serrano, PhD · Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO) & University Hospital Virgen de la Nieves

  • Valeria Denninghoff, PhD · Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-07-30
Completion
2026-07-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06997458 on ClinicalTrials.gov