Clinical trial NCT06997458: Liquid BiOpsy, Lung and Colon Cancer in AndaluciA
Official title: Clinical Implementation of Liquid Biopsy in Cancer Through Next Generation Sequencing (NGS) Panels in the Andalusian Public Health System
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Non Small Cell Lung Cancer (NSCLC)
Colorectal Cancer (CRC)
Keywords: Liquid Biopsy
cfDNA
ctDNA
Metastatic Cancer
NGS
Lead sponsor: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Sponsor class: OTHER
Collaborators: name: Tempus AI
First posted: 2025-05-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Metastatic adenocarcinoma (NSCLC: 250 and CRC: 250)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: through study completion, an average of 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO)
state: Andalucia
Study officials:
affiliation: Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO) & University Hospital Virgen de la Nieves
name: M Jose Serrano, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO)
name: Valeria Denninghoff, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Rolfo 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.
citation: Pisapia 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.
citation: Finkle 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.
citation: Malapelle 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.