Clinical trial · Observational
CLINICAL STUDY TO IDENTIFY BIOMARKERS FOR TUMOR SPREAD THROUGH AIR SPACES STATUS
UNCOVERING THE GENETIC LANDSCAPE OF LUNG ADENOCARCINOMA: A CLINICAL STUDY TO IDENTIFY BIOMARKERS FOR TUMOR SPREAD THROUGH AIR SPACES STATUS
- 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)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Retrospective Cohort I: 70 patients (35 patients for group 1 and 35 patients for group 2)
- description
- Group 1: patients newly diagnosed with early-stage LUAD, STAS negative Group 2: patients newly diagnosed with early-stage LUAD, STAS positive
- label
- Prospective Cohort II: 70 patients (35 patients for group 1 and 35 patients for group 2)
- description
- Group 1: patients newly diagnosed with early-stage LUAD, STAS negative Group 2: patients newly diagnosed with early-stage LUAD, STAS positive
Primary outcomes (1)
- measure
- Identification and quantification of specific gene miRNAs overexpression's
- timeFrame
- 1 year
- description
- \- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Incapability of understanding the study and/or providing consent * Signed informed consent unavailable
References
Publications (0)
Data not yet available