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Search / Trial NCT06997458

Liquid BiOpsy, Lung and Colon Cancer in AndaluciA

Launched by FUNDACIÓN PÚBLICA ANDALUZA PARA LA INVESTIGACIÓN BIOMÉDICA ANDALUCÍA ORIENTAL · May 21, 2025

Trial Information

Current as of October 04, 2025

Enrolling by invitation

Keywords

Liquid Biopsy Cf Dna Ct Dna Metastatic Cancer Ngs

ClinConnect Summary

The LOLA Project is an observational study in Andalusia that is looking at how using a large blood test (a liquid biopsy) called the xF Tempus panel in real life might change cancer care and costs. Researchers will use this test to look for genetic changes in metastatic non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (CRC) from blood samples. The main question is how often the test finds actionable variants—genetic changes that could influence treatment decisions—and how the test affects the way doctors work and the costs involved.

If you are eligible, you would be an adult (18+) with stage IV NSCLC or stage IV CRC who has not yet started systemic cancer treatment, and you would be able to consent to participate. You would have two blood tubes collected and sent to Tempus Labs for analysis with the xF Tempus assay. There is no experimental treatment given as part of the study; it is about testing use in real practice and measuring outcomes like turnaround time and resource use. The study plans to enroll about 500 people in Granada and is expected to run through roughly 2026, with ongoing monitoring by a safety and data oversight team.

Gender

ALL

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.

About Fundación Pública Andaluza Para La Investigación Biomédica Andalucía Oriental

The Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental is a prominent public foundation dedicated to advancing biomedical research in the Andalusia region of Spain. Committed to fostering innovation and collaboration, the foundation supports a wide range of clinical trials aimed at improving healthcare outcomes and enhancing the understanding of various medical conditions. Through strategic partnerships with academic institutions, healthcare providers, and industry stakeholders, the foundation plays a pivotal role in translating scientific discoveries into practical applications, ultimately contributing to the enhancement of patient care and public health in the region.

Locations

Granada, Andalucia, Spain

Patients applied

0 patients applied

Trial Officials

M Jose Serrano, PhD

Principal Investigator

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

Valeria Denninghoff, PhD

Study Director

Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported