Liquid BiOpsy, Lung and Colon Cancer in AndaluciA

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.

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Key information

Conditions

Non Small Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Cancer (CRC) Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO)

Granada, Andalusia, 18016, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

xF Tempus assay

Diagnostic Test

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).

Primary outcomes

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.

Time frame: through study completion, an average of 3 year

Proportion of patients with at least one actionable variant (%)

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

Other

Collaborators

Tempus AI

Registry information

Official study title

Clinical Implementation of Liquid Biopsy in Cancer Through Next Generation Sequencing (NGS) Panels in the Andalusian Public Health System

Acronym: LOLA-PROJECT

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: May 30, 2025
Registry last updated: May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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