Liquid BiOpsy, Lung and Colon Cancer in AndaluciA
LOLA-PROJECT
Clinical Implementation of Liquid Biopsy in Cancer Through Next Generation Sequencing (NGS) Panels in the Andalusian Public Health System
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2024
CompletedFirst Submitted
Initial submission to the registry
April 25, 2025
CompletedFirst Posted
Study publicly available on registry
May 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
ExpectedMay 30, 2025
May 1, 2025
12 months
April 25, 2025
May 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (%)
through study completion, an average of 3 year
Study Arms (2)
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
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).
Interventions
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 Criteria
Metastatic adenocarcinoma (NSCLC: 250 and CRC: 250)
You may qualify if:
- 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)
- +2 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO)
Granada, Andalusia, 18016, Spain
Related Publications (5)
Rolfo C, Cardona AF, Cristofanilli M, Paz-Ares L, Diaz Mochon JJ, Duran I, Raez LE, Russo A, Lorente JA, Malapelle U, Gil-Bazo I, Jantus-Lewintre E, Pauwels P, Mok T, Serrano MJ; ISLB. Challenges and opportunities of cfDNA analysis implementation in clinical practice: Perspective of the International Society of Liquid Biopsy (ISLB). Crit Rev Oncol Hematol. 2020 Jul;151:102978. doi: 10.1016/j.critrevonc.2020.102978. Epub 2020 May 5.
PMID: 32428812BACKGROUNDRolfo C, Denninghoff V. Globalization of precision medicine programs in lung cancer: a health system challenge. Lancet Reg Health Eur. 2023 Dec 12;36:100819. doi: 10.1016/j.lanepe.2023.100819. eCollection 2024 Jan. No abstract available.
PMID: 38170059BACKGROUNDPisapia P, Costa JL, Pepe F, Russo G, Gragnano G, Russo A, Iaccarino A, de Miguel-Perez D, Serrano MJ, Denninghoff V, Quagliata L, Rolfo C, Malapelle U. Next generation sequencing for liquid biopsy based testing in non-small cell lung cancer in 2021. Crit Rev Oncol Hematol. 2021 May;161:103311. doi: 10.1016/j.critrevonc.2021.103311. Epub 2021 Mar 26.
PMID: 33781866BACKGROUNDFinkle JD, Boulos H, Driessen TM, Lo C, Blidner RA, Hafez A, Khan AA, Lozac'hmeur A, McKinnon KE, Perera J, Zhu W, Dowlati A, White KP, Tell R, Beaubier N. Validation of a liquid biopsy assay with molecular and clinical profiling of circulating tumor DNA. NPJ Precis Oncol. 2021 Jul 2;5(1):63. doi: 10.1038/s41698-021-00202-2.
PMID: 34215841BACKGROUNDMalapelle U, Pisapia P, Addeo A, Arrieta O, Bellosillo B, Cardona AF, Cristofanilli M, De Miguel-Perez D, Denninghoff V, Duran I, Jantus-Lewintre E, Nuzzo PV, O'Byrne K, Pauwels P, Pickering EM, Raez LE, Russo A, Serrano MJ, Gandara DR, Troncone G, Rolfo C. Liquid biopsy from research to clinical practice: focus on non-small cell lung cancer. Expert Rev Mol Diagn. 2021 Nov;21(11):1165-1178. doi: 10.1080/14737159.2021.1985468. Epub 2021 Oct 11.
PMID: 34570988BACKGROUND
Related Links
Biospecimen
Streck tubes with 8.5mL of blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
M Jose Serrano, PhD
Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO) & University Hospital Virgen de la Nieves
- STUDY DIRECTOR
Valeria Denninghoff, PhD
Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 25, 2025
First Posted
May 30, 2025
Study Start
August 1, 2024
Primary Completion
July 30, 2025
Study Completion (Estimated)
July 30, 2026
Last Updated
May 30, 2025
Record last verified: 2025-05