Diagnostic Power Comparison Between VOCs and CTCs

May 30, 2019 updated by: Hu Liu, Anhui Medical University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
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.
From June 15,2019 to June 1,2020

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From June 1,2020 to Dec 31,2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anhui Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Technion, Israel Institute of Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hu Liu, MD, AnHui Provincial Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DPCVC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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