Diagnostic Power Comparison Between VOCs and CTCs

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Diagnostic Power of VOCs Compared With CTCs for Cancer

Conditions
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Circulating Tumor Cell, Volatile Organic Chemicals, Breast Cancer, Gastric Cancer, Diagnoses Disease

Intervention / Treatment
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* Diagnostic Test: Circulating tumor cells, Volatile organic compounds


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years Definitive diagnosis of gastric cancer, breast cancer,benign breast disease and gastric lesions ECOG(Eastern Cooperative Oncology Group) scores ≤ 2 Exclusion Criteria: Other palliative chemotherapy and radiotherapy for this cancer Other cancer Diabetes, Fatty liver Autoimmune disease Pulmonary ventilation dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastric cancer<br>patients with definitive diagnosis of gastric cancer by pathology | Diagnostic Test: Circulating tumor cells, Volatile organic compounds<br>* Alveolar exhaled breath samples and peripheral venous blood(10ml) will be collected from each patients<br>|
| Breast cancer<br>patients with definitive diagnosis of breast cancer by pathology | Diagnostic Test: Circulating tumor cells, Volatile organic compounds<br>* Alveolar exhaled breath samples and peripheral venous blood(10ml) will be collected from each patients<br>|
| Benign gastric diseases<br>Gastritis or gastric ulcer | Diagnostic Test: Circulating tumor cells, Volatile organic compounds<br>* Alveolar exhaled breath samples and peripheral venous blood(10ml) will be collected from each patients<br>|
| Benign breast diseases<br>Hyperplasia of mammary glands or mastitis | Diagnostic Test: Circulating tumor cells, Volatile organic compounds<br>* Alveolar exhaled breath samples and peripheral venous blood(10ml) will be collected from each patients<br>|
| Normal<br>healthy volunteers | Diagnostic Test: Circulating tumor cells, Volatile organic compounds<br>* Alveolar exhaled breath samples and peripheral venous blood(10ml) will be collected from each patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discrimination between Malignant and Benign Gastric/Breast Lesions and normal group with each diagnostic method (Na-nose/GC-MS/CTC) | 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. | From June 15,2019 to June 1,2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehensive diagnostic model of VOCs and CTCs | Organize predictive models of VOCs/CTCs and establish Comprehensive Diagnostic Model. | From June 1,2020 to Dec 31,2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CTCs, VOCs, Breast cancer, Gastric cancer, diagnoses