Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

Age 50-80 years Diagnosis of early stage of lung cancer No previous chemo or radiotherapy for lung cancer No previous malignancies within last 5 years No abuse of alcohol (no more than 1 litre of wine for day). No patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study Signed Informed Consent Completed questionnaire

Age 50-80 years high risk individuals (heavy smokers, subjects with pulmonary disease non-cancer related or with a familiar history of lung cancer disease) Recent (within 6 months) negative Chest X-ray or CT scan No previous malignancies within last 5 years No patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study Signed Informed Consent Completed questionnaire

breath sampling: all subjects exhale into two sterile Tedlar bags, connected to a mouthpiece, in a condition similar to traditional spirometry.

Urine will be collected usual urine container.

The blood sample (\~ 5 ml) will be taken with a serum separator tube.

Breath, urine and blood analysis

Roberto Gasparri, MD, PhD

The goal of this prospective, case-control study is to discover the specific "omics" biomarkers of early stage of lung cancer using the non-invasive samples (breath, urine and serum) in a total of 200 subjects (100 healthy controls and 100 lung cancer patient). The main questions it aims to answer are:

* Which are the "omics" biomarkers that characterize the early stage of lung cancer?
* How to Translate Laboratory Data into Clinical Data?

For each participant we will collected the breath, urine and blood samples. In lung cancer patients group the samples will be sample before lung cancer resection. The samples of Breath, urine and serum will be analysed using different type of analysis: eNose and the Gas Chromatography combined with Ion Mass Spectrometry (GC/IMS). Moreover, Serum will be analyzed by mass-spectrometry-based proteomics. The purpose of these analyses will be to find biomarkers capable of distinguishing the early-stage of lung cancer from the healthy group. Followup will be performed to evaluate the possible change of the volatolomic and proteomic profile.

All partecipants will sign the Informed Consent before the sampling procedures. In addition, they will complete the clinical questionnaire containing medical history, smoking history and psychological evaluation.We will conduct the trial according to the ICH Good Clinical Practice (GCP) guidelines. Keeping accurate and consistent records is essential to a cooperative study.The IEO Data Management Office will responsible of the study database and data management.

serum samples urine samples exhaled breath samples

Volatolomic and Proteomic Profile for Early Diagnosis of Lung Cancer

Volatolomic and Proteomic Profile; Breath, Urine and Serum as Non-invasive Tools for Early Diagnosis of Lung Cancer

Enrolling two cohorts at baseline: healthy individuals at high risk with negative LDCT (no suspicious oncological findings) vs. patients with early-stage I/II lung cancer candidates for surgical resection; sampling in lung cancer patients will be performed pre-intervention. We will assess and compare the serum and urinary proteomic and volatile organic compound profiles, serum and respiratory, of the two cohorts under study at baseline and changes in proteomic and volatile organic compound signature at 12 months from baseline.

The serum proteomic and serum volatomomic, urinary, and respiratory data will be compared using algorithms based on artificial intelligence and deep learning. Data from each test, including patient follow-up, will be analyzed using multivariate statistical analysis of samples with multivariable logistic and Cox proportional hazards regression models to identify the most significant variables.

University of Rome Tor Vergata

European Institute of Oncology

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Infections

Rare Diseases

Syndrome

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Pulmonary Emphysema

Emphysema

Acute Lung Injury

Bronchitis

Bronchitis, Chronic

Chronic Graft Versus Host Disease

Respiratory Distress Syndrome, Infant

Acute Respiratory Distress Syndrome

Acute Graft Versus Host Disease

Subjects who provide informed consent and meet the eligibility criteria will have 50 ml of blood collected and sent to Freenome or Freenome's designee for processing, testing, and storage, and will then complete a standard-of-care screening LDCT.

blood draw

April Allison, BS

Harris Naemi, BS / Joye Choy, BS

Study Coordinator

Chuanbo Xu, PhD

Nasibeh Vatankhah, MD

The PROACT LUNG study is a prospective multi-center observational study to validate a blood-based test for the early detection of lung cancer by collecting blood samples from high-risk participants who will undergo a routine, standard-of-care screening Low-Dose Computed Tomography (LDCT).

This is a prospective, multi-center, observational study to evaluate the performance of the Freenome Multiomics Blood Test in screening eligible participants for lung cancer.

Enrollment will be open to all eligible participants for screening chest CT scan as part of the Standard of Care (SOC) for lung cancer. Subjects who meet the eligibility criteria for this study and provide informed consent will be enrolled and blood sample collection must be completed within 30 days of signing the informed consent. Optimally, the screening chest CT will be completed on the same day of the study blood collection, however up to 45 days will be allowed after study blood collection to obtain a screening chest CT.

The study will also collect demographic data and relevant clinical data, such as medical history, lifestyle, occupational and environmental exposure(s), family history, and clinical laboratory data. All reports and clinical notes regarding the diagnostic tests and procedures related to lung cancer diagnosis or lung lesion assessment, such as histopathology and bronchoscopy reports, and diagnostic/follow-up images and imaging reports will be collected as part of follow up to the screening chest CT scan.

All enrolled subjects will be followed prospectively from the date of the baseline screening chest CT until a minimum of 24 months, or until a premature study endpoint inclusive of withdrawal of consent or death.

Blood specimens will be de-identified and used to validate the performance characteristics of the Freenome Multiomics Blood Test

Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

The PROACT LUNG Study: A Prospective, Observational,Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening (FRNM-007)

Clinical performance of the Freenome Blood Test, including sensitivity and specificity, in detecting lung cancer in subjects with positive and negative lung cancer outcomes during a 12-month follow-up period

Clinical performance of the Freenome Blood Test, including sensitivity and specificity, in detecting lung cancer in subjects with positive and negative lung cancer outcomes during a 24-month follow-up period

Freenome Holdings Inc.

patient conform pulmonary nodules on CT images

DNA were extracted from patients'plasma ,then the DNA was bisulfite converted and tested by DNA methylation assay.The results were combined with AI images to differentiate between benign and malignant lung nodules.

DNA methylation joint AI imaging

Linfu Zhou

Yichun Wang

Lung cancer is the leading cause of cancer deaths,and the key to reducing mortality in lung cancer patients is early diagnosis and treatment.Currently,peripheral blood DNA methylation is a novel in vitro molecular marker for tumors.Meanwhile artificial intelligence diagnostic system can further improve the diagnostic ability.The purpose of this study is to apply the overall DNA methylation level (i.e.,methylation profile) and the altered methylation degree of specific genes as tumor diagnostic indexes,and combined with the artificial intelligence imaging technology for the early and accurate diagnosis of lung cancer,to achieve the early detection,diagnosis,and treatment of lung cancer,and to effectively reduce the mortality rate of lung cancer.

DNA Methylation Combined With Artificial Intelligence Imaging to Identify Lung Nodules

DNA Methylation Combined With Artificial Intelligence Imaging for Early Benign and Malignant Differentiation of Lung Nodules:an Observational,Single-center Clinical Trial(MAGIC Study)

Construction of a diagnostic model for DNA methylation combined with AI imaging. Comparing the results of the model with pathologic diagnosis, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Volatolomic and Proteomic Profile for Early Diagnosis of Lung Cancer	NCT06341387	Lung Cancer Non-small Cell ... Non-small Cell ... Lung Cancer Dia...	Breath, urine a...	50 Years - 80 Years	European Institute of Oncology
Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening	NCT06122077	Lung Cancer Dia...	blood draw	50 Years -	Freenome Holdings Inc.
DNA Methylation Combined With Artificial Intelligence Imaging to Identify Lung Nodules	NCT06220305	Lung Cancer Dia...	DNA methylation...	20 Years - 80 Years	The First Affiliated Hospital with Nanjing Medical University

Spots Global Cancer Trial Database for lung cancer diagnosis