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| Name | Class |
|---|---|
| Technion, Israel Institute of Technology | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric cancer | patients with definitive diagnosis of gastric cancer by pathology |
| |
| Breast cancer | patients with definitive diagnosis of breast cancer by pathology |
| |
| Benign gastric diseases | Gastritis or gastric ulcer |
| |
| Benign breast diseases | Hyperplasia of mammary glands or mastitis |
| |
| Normal | healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circulating tumor cells, Volatile organic compounds | Diagnostic Test | Alveolar exhaled breath samples and peripheral venous blood(10ml) will be collected from each patients |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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200 patients or volunteers who undergo Gastroscopy or breast surgery in Anhui Provincial cancer hospital, Hefei, China
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuyang Bao, MD | Contact | +86 18555039598 | des_mond@outlook.com | |
| Hu Liu, MD | Contact | +86 13866175691 | drliuhu@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Hu Liu, MD | Anhui Provincial Cancer Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26540569 | Background | Barash O, Zhang W, Halpern JM, Hua QL, Pan YY, Kayal H, Khoury K, Liu H, Davies MP, Haick H. Differentiation between genetic mutations of breast cancer by breath volatolomics. Oncotarget. 2015 Dec 29;6(42):44864-76. doi: 10.18632/oncotarget.6269. | |
| 25159530 | Background | Amal H, Shi DY, Ionescu R, Zhang W, Hua QL, Pan YY, Tao L, Liu H, Haick H. Assessment of ovarian cancer conditions from exhaled breath. Int J Cancer. 2015 Mar 15;136(6):E614-22. doi: 10.1002/ijc.29166. Epub 2014 Sep 5. |
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| ID | Term |
|---|---|
| D009360 | Neoplastic Cells, Circulating |
| D001943 | Breast Neoplasms |
| D013274 | Stomach Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
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| 28000444 | Background | Nakhleh MK, Amal H, Jeries R, Broza YY, Aboud M, Gharra A, Ivgi H, Khatib S, Badarneh S, Har-Shai L, Glass-Marmor L, Lejbkowicz I, Miller A, Badarny S, Winer R, Finberg J, Cohen-Kaminsky S, Perros F, Montani D, Girerd B, Garcia G, Simonneau G, Nakhoul F, Baram S, Salim R, Hakim M, Gruber M, Ronen O, Marshak T, Doweck I, Nativ O, Bahouth Z, Shi DY, Zhang W, Hua QL, Pan YY, Tao L, Liu H, Karban A, Koifman E, Rainis T, Skapars R, Sivins A, Ancans G, Liepniece-Karele I, Kikuste I, Lasina I, Tolmanis I, Johnson D, Millstone SZ, Fulton J, Wells JW, Wilf LH, Humbert M, Leja M, Peled N, Haick H. Diagnosis and Classification of 17 Diseases from 1404 Subjects via Pattern Analysis of Exhaled Molecules. ACS Nano. 2017 Jan 24;11(1):112-125. doi: 10.1021/acsnano.6b04930. Epub 2016 Dec 21. |
| 23899275 | Background | Leja MA, Liu H, Haick H. Breath testing: the future for digestive cancer detection. Expert Rev Gastroenterol Hepatol. 2013 Jul;7(5):389-91. doi: 10.1586/17474124.2013.811033. No abstract available. |
| 24184568 | Background | Amal H, Leja M, Broza YY, Tisch U, Funka K, Liepniece-Karele I, Skapars R, Xu ZQ, Liu H, Haick H. Geographical variation in the exhaled volatile organic compounds. J Breath Res. 2013 Dec;7(4):047102. doi: 10.1088/1752-7155/7/4/047102. Epub 2013 Nov 1. |
| 22888249 | Background | Amal H, Ding L, Liu BB, Tisch U, Xu ZQ, Shi DY, Zhao Y, Chen J, Sun RX, Liu H, Ye SL, Tang ZY, Haick H. The scent fingerprint of hepatocarcinoma: in-vitro metastasis prediction with volatile organic compounds (VOCs). Int J Nanomedicine. 2012;7:4135-46. doi: 10.2147/IJN.S32680. Epub 2012 Jul 30. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |