Circulating Tumor CellNCT03958812
Diagnostic Power Comparison Between VOCs and CTCs
An observational study of Circulating Tumor Cell and Volatile Organic Chemicals, run by Anhui Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Circulating Tumor Cell, Volatile Organic Chemicals, Breast Cancer
- What is being tested?
- Circulating tumor cells, Volatile organic compounds
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 200 patients or volunteers who undergo Gastroscopy or breast surgery in Anhui Provincial cancer hospital, Hefei, China
Who may be able to join
- 18-75 years
- Definitive diagnosis of gastric cancer, breast cancer,benign breast disease and gastric lesions
- ECOG(Eastern Cooperative Oncology Group) scores ≤ 2
Who cannot join
- Other palliative chemotherapy and radiotherapy for this cancer
- Other cancer
- Diabetes, Fatty liver
- Autoimmune disease
- Pulmonary ventilation dysfunction
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Diagnostic Power of VOCs Compared With CTCs for Cancer
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.
Read the 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.
- Conditions
- Circulating Tumor Cell, Volatile Organic Chemicals, Breast Cancer, Gastric Cancer, Diagnoses Disease
- Being tested
- Circulating tumor cells, Volatile organic compounds
- Keywords
- CTCs, VOCs, Breast cancer, Gastric cancer, diagnoses
- Medical subject headings
- Neoplastic Cells, Circulating, Breast Neoplasms, Stomach Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating tumor cells, Volatile organic compoundsDiagnostic test
Alveolar exhaled breath samples and peripheral venous blood(10ml) will be collected from each patients
| Study group | Role | What they receive |
|---|---|---|
| Gastric cancer | patients with definitive diagnosis of gastric cancer by pathology Receives: Diagnostic Test: Circulating tumor cells, Volatile organic compounds | |
| Breast cancer | patients with definitive diagnosis of breast cancer by pathology Receives: Diagnostic Test: Circulating tumor cells, Volatile organic compounds | |
| Benign gastric diseases | Gastritis or gastric ulcer Receives: Diagnostic Test: Circulating tumor cells, Volatile organic compounds | |
| Benign breast diseases | Hyperplasia of mammary glands or mastitis Receives: Diagnostic Test: Circulating tumor cells, Volatile organic compounds | |
| Normal | healthy volunteers Receives: Diagnostic Test: Circulating tumor cells, Volatile organic compounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From June 15,2019 to June 1,2020
Secondary outcomes (1)
Comprehensive diagnostic model of VOCs and CTCs
Organize predictive models of VOCs/CTCs and establish Comprehensive Diagnostic Model.
Measured: From June 1,2020 to Dec 31,2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start15 Jun 2019 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Circulating Tumor CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Responsible party
- Principal investigator, Hu Liu, Anhui Provincial Hospital
- Investigators
- Hu Liu, MD, Principal investigator, Anhui Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958812
- Sponsor's protocol ID
- DPCVC
- Status last verified
- May 2019
- First submitted
- 20 May 2019
- Last updated
- 3 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 26540569Amal 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.
PubMed 25159530Nakhleh 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.
PubMed 28000444Leja 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.
PubMed 23899275Amal 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.
PubMed 24184568Amal 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.
PubMed 22888249
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Power of VOCs Compared With CTCs for Cancer
- ClinicalTrials.gov ID
- NCT03958812
- Acronym / sponsor ID
- DPCVC
- Conditions
- Circulating Tumor Cell, Volatile Organic Chemicals, Breast Cancer, Gastric Cancer, Diagnoses Disease
- Keywords
- CTCs, VOCs, Breast cancer, Gastric cancer, diagnoses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Study start
- 15 Jun 2019 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Gastric cancer | – | Diagnostic Test: Circulating tumor cells, Volatile organic compoundspatients with definitive diagnosis of gastric cancer by pathology |
| Breast cancer | – | Diagnostic Test: Circulating tumor cells, Volatile organic compoundspatients with definitive diagnosis of breast cancer by pathology |
| Benign gastric diseases | – | Diagnostic Test: Circulating tumor cells, Volatile organic compoundsGastritis or gastric ulcer |
| Benign breast diseases | – | Diagnostic Test: Circulating tumor cells, Volatile organic compoundsHyperplasia of mammary glands or mastitis |
| Normal | – | Diagnostic Test: Circulating tumor cells, Volatile organic compoundshealthy volunteers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 200 patients or volunteers who undergo Gastroscopy or breast surgery in Anhui Provincial cancer hospital, Hefei, China
Key inclusion criteria (3 listed)
- 18-75 years
- Definitive diagnosis of gastric cancer, breast cancer,benign breast disease and gastric lesions
- ECOG(Eastern Cooperative Oncology Group) scores ≤ 2
Key exclusion criteria (5 listed)
- Other palliative chemotherapy and radiotherapy for this cancer
- Other cancer
- Diabetes, Fatty liver
- Autoimmune disease
- Pulmonary ventilation dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulating tumor cells, Volatile organic compoundsAlveolar exhaled breath samples and peripheral venous blood(10ml) will be collected from each patients | Diagnostic test | Benign breast diseases, Benign gastric diseases, Breast cancer, Gastric cancer, Normal |
Primary outcome
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.
1 secondary outcome
Comprehensive diagnostic model of VOCs and CTCs
Time frame: From June 1,2020 to Dec 31,2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Background: PubMed 26540569Barash 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.
- Background: PubMed 25159530Amal 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.
- Background: PubMed 28000444Nakhleh 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.
- Background: PubMed 23899275Leja 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.
- Background: PubMed 24184568Amal 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.
- Background: PubMed 22888249Amal 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.
- Individual participant dataSharing planned: Undecided
Related trials for Circulating Tumor Cell
Not yet recruitingPhase 3
Circulating Tumor DNA MRD-Guided Adjuvant Therapy for Curatively Resected Locally Advanced Esophageal Squamous Cell Carcinoma
Esophageal Cancer
Not yet recruiting
A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.
NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer)
Active, not recruitingObservational study
Circulating Tumor Cells (CTC) in Lung Cancer
Lung Neoplasms
Active, not recruitingPhase 2
Assessing a ctDNA and PET-oriented Therapy in Patients With DLBCL A Multicenter, Open-label, Phase II Trial.
Diffuse Large B-cell Lymphoma
RecruitingObservational study
Circulating Tumor Cell Analysis in Patients With Localized Prostate Cancer Undergoing Prostatectomy
Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hu Liu, MD principal investigator
Anhui Provincial Cancer Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Circulating Tumor Cell and Volatile Organic Chemicals, run by Anhui Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuyang Bao, MD (+86 18555039598, des_mond@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03958812, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.