Liquid BiOpsy, Lung and Colon Cancer in AndaluciA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-07-30

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with radiologic evidence of metastatic (stage IV) 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

xF Tempus assay

Intervention Type 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).

Patients with radiologic evidence of metastatic (stage IV) 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).

xF Tempus assay

Intervention Type 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).

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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María José Serrano Fernández

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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M Jose Serrano, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO) & University Hospital Virgen de la Nieves