CLINICAL STUDY TO IDENTIFY BIOMARKERS FOR TUMOR SPREAD THROUGH AIR SPACES STATUS
PAIR-LUNG
UNCOVERING THE GENETIC LANDSCAPE OF LUNG ADENOCARCINOMA: A CLINICAL STUDY TO IDENTIFY BIOMARKERS FOR TUMOR SPREAD THROUGH AIR SPACES STATUS
1 other identifier
observational
140
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2026
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
June 5, 2026
June 1, 2026
2.1 years
June 1, 2026
June 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Secondary Outcomes (1)
Creation of in vitro model to recapitulate STAS-positive LUAD microenvironment
1 year
Study Arms (2)
Retrospective Cohort I: 70 patients (35 patients for group 1 and 35 patients for group 2)
Group 1: patients newly diagnosed with early-stage LUAD, STAS negative Group 2: patients newly diagnosed with early-stage LUAD, STAS positive
Prospective Cohort II: 70 patients (35 patients for group 1 and 35 patients for group 2)
Group 1: patients newly diagnosed with early-stage LUAD, STAS negative Group 2: patients newly diagnosed with early-stage LUAD, STAS positive
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidade Nova de Lisboalead
- Unidade Local de Saúde de São Josécollaborator
Study Sites (2)
NMS Research | Cancer Nanomedicine - João Conde's Lab
Lisbon, Portugal
Unidade Local de Saúde de São José
Lisbon, Portugal
Biospecimen
Paraffined tumor tissue and blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2026
First Posted
June 5, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2029
Last Updated
June 5, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
IPD will not be shared due to data protection, privacy, and confidentiality considerations. The dataset may contain sensitive health information and the informed consent obtained from participants does not include provisions for broad data sharing with external researchers. Aggregate results will be published in peer-reviewed journals and may be made publicly available, but IPD access will be limited to authorized study personnel for the purposes of analysis and regulatory compliance.