Liquid BiOpsy, Lung and Colon Cancer in AndaluciA (LOLA-PROJECT)

Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

Status: Invitation-only

Conditions: Colorectal Cancer (CRC); Non Small Cell Lung Cancer (NSCLC)

Treatments: Diagnostic Test: xF Tempus assay

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06997458

LCI2024-2027

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

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

Treatment:

Diagnostic Test: xF Tempus assay

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).

Treatment:

Diagnostic Test: xF Tempus assay