CLINICAL STUDY TO IDENTIFY BIOMARKERS FOR TUMOR SPREAD THROUGH AIR SPACES STATUS

ConditionLung Adenocarcinoma

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversidade Nova de Lisboa

About this trial

Lung cancer remains a significant challenge in oncology, with poor prognosis for patients, especially those with advanced-stage disease. The phenomenon of tumor spread through air spaces (STAS) in pulmonary cancer has garnered attention for its association with aggressive tumor behavior and adverse clinical outcomes. Spread through air spaces identification has been highly debatable on scientific community as an important prognostic feature for distant and locoregional recurrence and as a key player in the differential diagnosis and selection of the appropriate treatment. The aim of this study is to unravel the complexities of STAS-positive lung adenocarcinoma (LUAD) diagnosis and treatment options. For that, we intend to (1) isolate primary lung cancer tissues from early-stages lung adenocarcinoma to fabricate organoid in vitro models and (2) evaluate the microRNA (miRNA) profile of tumor and healthy tissue samples. This is a Hybrid (prospective and retrospective) observational clinical study with a nested translational study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients older than 18 years old

Active early LUAD diagnosis according to the American Joint Committee on Cancer

Signed informed consent or previous consent given for future research

Disqualifiers

History of inflammatory bowel disease and autoimmune diseases

History of hepatic disease (including history of alcoholic or viral hepatitis)

LUAD patients with other active malignancy(ies)

Previous treatment for LUAD

Trial population

Cohort I: Retrospective data collection 70 patients who have undergone LUAD surgery at the Thoracic Surgery Unity of ULS DE SÃO JOSÉ (35 patients for group 1 and 35 patients for group 2). In this cohort, we use banked formalin-fixed paraffin embedded (FFPE) tissue samples for analysis. Cohort II: Prospective data Collection 70 patients diagnosed with LUAD in ULSSJ will be invited to participate in the study (35 patients for group 1 and 35 patients for group 2). In this cohort of patients, we will prospectively perform a non-interventional study to recruit LUAD patients and analyze the clinical impact of the STAS pattern in patients with LUAD.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

140 Participants

are grouped into 2 trial groups

Group A: Retrospective Cohort I: 70 patients (35 patients for group 1 and 35 patients for group 2)

Group B: Prospective Cohort II: 70 patients (35 patients for group 1 and 35 patients for group 2)

Trial outcomes

Primary outcomes

Identification and quantification of specific gene miRNAs overexpression's

\- Identify and quantify specific gene miRNAs ubiquitously overexpressed in paraffined tumor tissue and in blood samples of STAS-positive patients in comparison with other LUAD patient group.

Time frame

1 year

Secondary outcomes

Creation of in vitro model to recapitulate STAS-positive LUAD microenvironment

* Isolation of LUAD patient-derived cells to fabricate an organoid in vitro model to better recapitulate STAS-positive LUAD microenvironment. * Assessment of correlation between demographic and clinical parameters, and STAS presence in LUAD patients.

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade Nova de Lisboa

Lead sponsor

Unidade Local de Saúde de São José

Collaborator

Source ClinicalTrials.gov

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