Diagnostic Power Comparison Between VOCs and CTCs

Anhui Medical University

Status: Unknown

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

Treatments: Diagnostic Test: Circulating tumor cells, Volatile organic compounds

Study type: Observational

Funder types: Other

Identifiers

NCT03958812

DPCVC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 5 patient groups

Gastric cancer

Description:

patients with definitive diagnosis of gastric cancer by pathology

Treatment:

Diagnostic Test: Circulating tumor cells, Volatile organic compounds

Breast cancer

Description:

patients with definitive diagnosis of breast cancer by pathology

Treatment:

Diagnostic Test: Circulating tumor cells, Volatile organic compounds

Benign gastric diseases

Description:

Gastritis or gastric ulcer

Treatment:

Diagnostic Test: Circulating tumor cells, Volatile organic compounds

Benign breast diseases

Description:

Hyperplasia of mammary glands or mastitis

Treatment:

Diagnostic Test: Circulating tumor cells, Volatile organic compounds

Normal

Description:

healthy volunteers

Treatment:

Diagnostic Test: Circulating tumor cells, Volatile organic compounds