Clinical trial · Observational
Liquid BiOpsy, Lung and Colon Cancer in AndaluciA
Clinical Implementation of Liquid Biopsy in Cancer Through Next Generation Sequencing (NGS) Panels in the Andalusian Public Health System
NCT06997458CI-TRIAL-00090365LOLA-PROJECTenrolling by invitationClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| xF Tempus assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients with radiologic evidence of metastatic (stage IV) NSCLC
- description
- * 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
- interventionNames
- Diagnostic Test: xF Tempus assay
- label
- Patients with radiologic evidence of metastatic (stage IV) CRC
- description
- * 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).
- interventionNames
- Diagnostic Test: xF Tempus assay
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDRolfo 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 32428812
- BACKGROUNDRolfo 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 38170059
- BACKGROUNDPisapia 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 33781866
- BACKGROUNDFinkle 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 34215841
- BACKGROUNDMalapelle 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 34570988