Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Breast Neoplasms

Neoplastic Cells, Circulating

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Neoplasm Metastasis

Neoplastic Processes

Stomach Cancer

patients with definitive diagnosis of gastric cancer by pathology

patients with definitive diagnosis of breast cancer by pathology

Hyperplasia of mammary glands or mastitis

Alveolar exhaled breath samples and peripheral venous blood(10ml) will be collected from each patients

Circulating tumor cells, Volatile organic compounds

Chuyang Bao, MD

Hu Liu, MD

Early diagnosis of malignant tumors is pivotal for improving their prognoses. Circulating tumor cells (CTC) in peripheral blood and Volatile organic compounds (VOCs) in exhaled breath are newly developed diagnosis method. Due to the low percentage of CTCs in peripheral blood of cancer patients and the surface structure of lymphocytes (especially megakaryocytes) is often confused with tumor cells, CTC has a high false positive and negative rate. In recent years, the detection of volatile organic compounds (VOCs) in exhaled breath as a simple and noninvasive method has shown broad application prospects in the diagnosis of various diseases. A series of studies of VOCs diagnosing solid tumors the investigators had conducted in the past decade show that VOCs can not only distinguish different types of tumors, but also can make a distinction between different stages. This study was to compare CTC and VOCs with clinical samples. Predictive models will be built employing discriminant factor analysis (DFA) pattern recognition method. Sensitivity and specificity will be determined using leave-one-out cross-validation or an independent blind test set.

200 patients with definitive diagnoses will be enrolled and the alveolar exhaled breath samples and peripheral venous blood will be collected. Two blood samples and two breath samples will be collected from each patient. One blood sample will be send to CTC tests for a blind test and the other will be used for headspace VOCs analyses. One breath sample was used for analysis with the Nano-sensors array, and the other was used for gas chromatography coupled with mass spectrometry (GC-MS) analysis. The VOCs samples were collected using sorbent tubes at a total flow through sorption trap of 200ml/min, then will be send to Israel Institute of Technology for further test.

Diagnostic Power Comparison Between VOCs and CTCs

The Diagnostic Power of VOCs Compared With CTCs for Cancer

Exhaled breath samples and peripheral venous blood collected will be used to build predictive models employing discriminant factor analysis (DFA) and thereafter examine the sensitivity and specificity of model identification.

Organize predictive models of VOCs/CTCs and establish Comprehensive Diagnostic Model.

Technion, Israel Institute of Technology

Anhui Medical University

Associate Professor

Patients with definitively diagnosed of solid tumors

Patients with definitively diagnosed of benign disease or precancerous lesion

Chemical sensors based on Monolayer-Capped Metallic Nanoparticles (MCMNPs) can recognize and classify exhaled breath by special recognition algorithm, which achieves the purpose of disease diagnosis.

Nanomaterial-based sensors

Bao Chuyang, MD

Early diagnoses of malignant tumors are pivotal for improving their prognoses. The Exhaled Breath is made up of oxygen, carbon dioxide, nitrogen, water, inert gases and volatile organic compounds (VOCs). Theoretically, the concentration of VOCs in exhalation produced by metabolism in human body is only about nmol/L-pmol/L, which can significantly increase under certain pathological conditions. A series of studies of VOCs diagnosing solid tumors the investigators had been conducted in the past decade. It was found that VOCs in exhaled breath can not only distinguish different types of tumors, but also can make a clear distinction between different stages. Our long-term collaborator, Professor Hossam Haick (Israel Institute of Technology) has developed a nano sensor array, so called Na-nose, which can detect VOCs of the exhaled breath by binding gases to specific chemiresistors coated with gold nanomaterials. The Na-nose has the advantages of low cost, easy to use, good reproducibility and real-time detection for large scale clinical application. This study was to use large clinical samples to validate the diagnostic efficacy of the newly developed Nano-nose( Sniffphone and Breath Screener) for malignant tumors .

Israel Institute of Technology provides two type of Na-nose. One is Breath Screener used for large-scale sampling and feature VOCs extraction to establish database. The other is called Sniff Phone aim at clinical real-time VOCs detection assisted by software. About 10,000 patients will participate in the subject of Breath Screener in batches. First, 7000 patients will have a definitive diagnosis and exhaled breath collected. Feature VOCs of specific tumors will be extracted from these samples and employed to build predictive model by using discriminant factor analysis (DFA). After the predictive model had been completed, 3000 definitively diagnosed patients will participate in validating the specificity and sensitivity of the prediction model. With the assistance of Breath Screener clinical database and software services, Sniff Phone is more suitable for clinical real-time detection for its small and convenient design characteristics. At last, Breath Screener and Sniff Phone will continue enriching databases and improve diagnosis efficacy in their clinical applications.

Cancer Diagnoses From Exhaled Breath With Na-nose

Diagnosing Cancers From Healthy From Human Exhaled Breath With Na-nose

First, feature VOCs of specific tumors will be extracted from part of collected samples and employed to build predictive model. After the predictive model had been completed, number of definitively diagnosed patients will participate in validating the specificity and sensitivity of the prediction model.

Integrate the correlation and relevance between the exhaled samples and the differentially expressed genes in the cancer group and the benign / normal control group to explore the mechanism of feature VOCs' production.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Diagnostic Power Comparison Between VOCs and CTCs	NCT03958812	Circulating Tum... Volatile Organi... Breast Cancer Gastric Cancer Diagnoses Disea...	Circulating tum...	18 Years - 75 Years	Anhui Medical University
Cancer Diagnoses From Exhaled Breath With Na-nose	NCT03967652	Volatile Organi... Cancer Diagnoses Disea...	Nanomaterial-ba...	18 Years - 75 Years	Anhui Medical University

Spots Global Cancer Trial Database for volatile organic chemicals