Liquid BiOpsy, Lung and Colon Cancer in AndaluciA

• Conditions: Non Small Cell Lung Cancer (NSCLC); Colorectal Cancer (CRC)

• Registration Number: NCT06997458
• Lead Sponsor: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-01
• Study First Submitted: 2025-04-25
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Study First Posted: 2025-05-30
• Last Update Posted: 2025-05-30
• Primary Completion: 2025-07-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

General criteria:

• More than 18 years old
• Both genders
• Ability to provide written informed consent

Specific criteria:

• NSCLC

  • Patients diagnosed with the 8th Edition of the Tumor, Node, Metastasis (TNM) staging system for Lung Cancer approved by International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC): IV (Any T, Any N, M1a-c)
  • Histologically confirmed NSCLC (adenocarcinoma)
  • Performance status of 0-2 (ECOG PS) ○ Estimated life expectancy ≥3 months
  • Treatment naïve patients (chemotherapy, immunotherapy, targeted therapy, radiotherapy).
  • Smokers or Non-Smokers

• CRC

  • Patients diagnosed with the Tumor, Node, Metastasis (TNM) staging system for Colorectal Cancer approved by the American Joint Committee on Cancer (AJCC): IV (Any T, Any N, M1a-c)
  • Histologically confirmed CRC (adenocarcinoma)
  • Performance status of 0-2 (ECOG PS)
  • Estimated life expectancy ≥3 months
  • Treatment naïve patients (chemotherapy, immunotherapy, targeted therapy, radiotherapy).

Exclusion Criteria

• General: History of any other cancer within the previous 5 years, except non-melanoma skin cancer
• General: Absence of Informed consent. > Pregnant or nursing women. > Small cell lung cancer.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO); 🇪🇸 Granada, Andalucia, Spain