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出境医 / 临床实验 / Diagnostic Power Comparison Between VOCs and CTCs

Diagnostic Power Comparison Between VOCs and CTCs

Study Description
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.

Condition or disease Intervention/treatment
Circulating Tumor Cell Volatile Organic Chemicals Breast Cancer Gastric Cancer Diagnoses Disease Diagnostic Test: Circulating tumor cells, Volatile organic compounds

Detailed Description:
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.
Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Diagnostic Power of VOCs Compared With CTCs for Cancer
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
Group/Cohort Intervention/treatment
Gastric cancer
patients with definitive diagnosis of gastric cancer by pathology
 Diagnostic Test: Circulating tumor cells, Volatile organic compounds
Alveolar exhaled breath samples and peripheral venous blood(10ml) will be collected from each patients
Breast cancer
patients with definitive diagnosis of breast cancer by pathology
 Diagnostic Test: Circulating tumor cells, Volatile organic compounds
Alveolar exhaled breath samples and peripheral venous blood(10ml) will be collected from each patients
Benign gastric diseases
Gastritis or gastric ulcer
 Diagnostic Test: Circulating tumor cells, Volatile organic compounds
Alveolar exhaled breath samples and peripheral venous blood(10ml) will be collected from each patients
Benign breast diseases
Hyperplasia of mammary glands or mastitis
 Diagnostic Test: Circulating tumor cells, Volatile organic compounds
Alveolar exhaled breath samples and peripheral venous blood(10ml) will be collected from each patients
Normal
healthy volunteers
 Diagnostic Test: Circulating tumor cells, Volatile organic compounds
Alveolar exhaled breath samples and peripheral venous blood(10ml) will be collected from each patients
Outcome Measures
Primary Outcome Measures :
  1. Discrimination between Malignant and Benign Gastric/Breast Lesions and normal group with each diagnostic method (Na-nose/GC-MS/CTC) [ Time Frame: From June 15,2019 to June 1,2020 ]
    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.


Secondary Outcome Measures :
  1. Comprehensive diagnostic model of VOCs and CTCs [ Time Frame: From June 1,2020 to Dec 31,2020 ]
    Organize predictive models of VOCs/CTCs and establish Comprehensive Diagnostic Model.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
200 patients or volunteers who undergo Gastroscopy or breast surgery in Anhui Provincial cancer hospital, Hefei, China
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Chuyang Bao, MD +86 18555039598 des_mond@outlook.com
Contact: Hu Liu, MD +86 13866175691 drliuhu@yahoo.com

Sponsors and Collaborators
Anhui Medical University
Technion, Israel Institute of Technology
Investigators
Layout table for investigator information
Principal Investigator: Hu Liu, MD Anhui Provincial Cancer Hospital
Tracking Information
First Submitted Date May 20, 2019
First Posted Date May 22, 2019
Last Update Posted Date June 3, 2019
Estimated Study Start Date June 15, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 30, 2019) 		Discrimination between Malignant and Benign Gastric/Breast Lesions and normal group with each diagnostic method (Na-nose/GC-MS/CTC) [ Time Frame: From June 15,2019 to June 1,2020 ]
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.
Original Primary Outcome Measures
 (submitted: May 20, 2019) 		Discrimination between Malignant and Benign Gastric/Breast Lesions and normal group with each diagnosis methods (Na-nose/GC-MS/CTC) [ Time Frame: From June 15,2019 to June 1,2020 ]
Exhaled breath samples and peripheral venous blood collected will going be use to build a predictive models employing discriminant factor analysis (DFA). Comparison of postoperative pathological examination results or endoscopy results, examine the sensitivity and specificity of model identification.
Change History
Current Secondary Outcome Measures
 (submitted: May 30, 2019) 		Comprehensive diagnostic model of VOCs and CTCs [ Time Frame: From June 1,2020 to Dec 31,2020 ]
Organize predictive models of VOCs/CTCs and establish Comprehensive Diagnostic Model.
Original Secondary Outcome Measures
 (submitted: May 20, 2019) 		Cmprhensive diagnostic model of VOCs and CTCs [ Time Frame: From June 1,2020 to Dec 31,2020 ]
Organize predictive models of VOCs/CTCs and establishment of Comprehensive Diagnostic Model.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnostic Power Comparison Between VOCs and CTCs
Official Title The Diagnostic Power of VOCs Compared With CTCs for Cancer
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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 200 patients or volunteers who undergo Gastroscopy or breast surgery in Anhui Provincial cancer hospital, Hefei, China
Condition
  • Circulating Tumor Cell
  • Volatile Organic Chemicals
  • Breast Cancer
  • Gastric Cancer
  • Diagnoses Disease
Intervention Diagnostic Test: Circulating tumor cells, Volatile organic compounds
Alveolar exhaled breath samples and peripheral venous blood(10ml) will be collected from each patients
Study Groups/Cohorts
  • Gastric cancer
    patients with definitive diagnosis of gastric cancer by pathology
    Intervention: Diagnostic Test: Circulating tumor cells, Volatile organic compounds
  • Breast cancer
    patients with definitive diagnosis of breast cancer by pathology
    Intervention: Diagnostic Test: Circulating tumor cells, Volatile organic compounds
  • Benign gastric diseases
    Gastritis or gastric ulcer
    Intervention: Diagnostic Test: Circulating tumor cells, Volatile organic compounds
  • Benign breast diseases
    Hyperplasia of mammary glands or mastitis
    Intervention: Diagnostic Test: Circulating tumor cells, Volatile organic compounds
  • Normal
    healthy volunteers
    Intervention: Diagnostic Test: Circulating tumor cells, Volatile organic compounds
Publications *
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 20, 2019) 		200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03958812
Other Study ID Numbers DPCVC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Hu Liu, Anhui Provincial Hospital
Study Sponsor Anhui Medical University
Collaborators Technion, Israel Institute of Technology
Investigators
Principal Investigator: Hu Liu, MD Anhui Provincial Cancer Hospital
PRS Account Anhui Medical University
Verification Date May 2019

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