Diagnostic Power Comparison Between VOCs and CTCs

NCT03958812 | Unknown

• 1 other identifier: DPCVC
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Circulating Tumor Cell; Volatile Organic Chemicals; Breast Cancer; Gastric Cancer; Diagnoses Disease

Keywords

CTCs; VOCs; Breast cancer; Gastric cancer; diagnoses

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comprehensive diagnostic model of VOCs and CTCs

  From June 1,2020 to Dec 31,2020

Study Arms (5)

Gastric cancer

patients with definitive diagnosis of gastric cancer by pathology

Diagnostic Test: Circulating tumor cells, Volatile organic compounds

Breast cancer

patients with definitive diagnosis of breast cancer by pathology

Diagnostic Test: Circulating tumor cells, Volatile organic compounds

Benign gastric diseases

Gastritis or gastric ulcer

Diagnostic Test: Circulating tumor cells, Volatile organic compounds

Benign breast diseases

Hyperplasia of mammary glands or mastitis

Diagnostic Test: Circulating tumor cells, Volatile organic compounds

Normal

healthy volunteers

Diagnostic Test: Circulating tumor cells, Volatile organic compounds

Interventions

Circulating tumor cells, Volatile organic compounds DIAGNOSTIC_TEST

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

Benign breast diseases; Benign gastric diseases; Breast cancer; Gastric cancer; Normal

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

200 patients or volunteers who undergo Gastroscopy or breast surgery in Anhui Provincial cancer hospital, Hefei, China

You may qualify if:

• years
• Definitive diagnosis of gastric cancer, breast cancer,benign breast disease and gastric lesions
• ECOG(Eastern Cooperative Oncology Group) scores ≤ 2

You may not qualify if:

• Other palliative chemotherapy and radiotherapy for this cancer
• Other cancer
• Diabetes, Fatty liver
• Autoimmune disease
• Pulmonary ventilation dysfunction

Sponsors & Collaborators

• Anhui Medical University: lead
• Technion, Israel Institute of Technology: collaborator

Related Publications (6)

• 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.

  PMID: 26540569 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.

  PMID: 25159530 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.

  PMID: 28000444 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.

  PMID: 23899275 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.

  PMID: 24184568 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.

  PMID: 22888249 BACKGROUND

MeSH Terms

Conditions

Neoplastic Cells, Circulating; Breast Neoplasms; Stomach Neoplasms; Disease

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Hu Liu, MD

  Anhui Provincial Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chuyang Bao, MD

CONTACT

+86 18555039598; des_mond@outlook.com

Hu Liu, MD

CONTACT

+86 13866175691; drliuhu@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 22, 2019
• Study Start: June 15, 2019
• Primary Completion: June 1, 2020
• Study Completion: December 31, 2020
• Last Updated: June 3, 2019

Record last verified: 2019-05