Liquid BiOpsy, Lung and Colon Cancer in AndaluciA

N/AEnrolling By InvitationNCT06997458

Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

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

Interventions

xF Tempus assayDIAGNOSTIC_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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Granada, Andalusia, Spain

Outcomes

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.

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

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

Data from ClinicalTrials.gov

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