Colorectal Cancer (CRC), Non Small Cell Lung Cancer (NSCLC)
Conditions
Keywords
Liquid Biopsy, cfDNA, ctDNA, Metastatic Cancer, NGS
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.
Interventions
DIAGNOSTIC_TESTxF 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
Tempus AI
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 (%) |
Countries
Spain
Outcome results
None listed