NCT03958812

Diagnostic Power Comparison Between VOCs and CTCs

The Diagnostic Power of VOCs Compared With CTCs for Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Circulating tumor cells, Volatile organic compounds	Alveolar exhaled breath samples and peripheral venous blood(10ml) will be collected from each patients

Timeline

• Start date: 2019-06-15
• Primary completion: 2020-06-01
• Completion: 2020-12-31
• First posted: 2019-05-22
• Last updated: 2019-06-03