【ChiCTR-SPD-17011540】Non-invasive urine test for cancers

ChiCTR-SPD-17011540

正在进行

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2017-06-01

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Nasopharyngeal Cancer, Breast Cancer, Gastric Cancer, Colorectal Cancer

Non-invasive urine test for cancers

Diagnostic Tools for non-invasive Assessment of Cell Phenotypes and Cancer from Patient fluids

The purpose of this study is to test the NuTEC screebubg platform for a broad-based, non-invasive cancer screening process using clinical samples from a Chinese genetic population. It is believed that changes in circulating plasma proteins and small molecules occur in patients with cancer, and we will use the NuTEC technology to screen for these changes.

诊断试验诊断准确性

探索性研究/预试验

The first phase of the study will be to develop a statistical learning set. If this set of samples proves informative, then a blinded test will be performed. Not applicable, unless the NuTECs prove to be predictive for detecting the tested cancer

Learning Set – None. Sufficient samples will be acquired without personal information but coded (to indicate control versus disease) to develop a statistical learning set sufficiently robust to permit algorithm predictions of the cancer state versus the control state. Based on preliminary data, we predict that approximately 50-100 samples of both control and diseased samples will be required for this; however, the numbers of samples are not fixed as this is a pilot study. Post-learning set phase – modified single blinded study. For this, a modified single-blinded study will be initiated in which the physicians in Fuzhou will know the patient status (control or diseased) and will provide coded samples for screening against the NuTECs. The aims of these experiments are to determine sensitivity and specificity. Development study – double-blinded. Patients suspected of having a cancer (but unverified) will have urine samples acquired and tested against the NuTECs. All samples will be coded and at the completion of the study, revealed to confirm screening applicability of tests relative to known hospital standards. As some patients will not be diagnosed with cancer, the screening test will be used to verify or invalidate initial assessments.

Entopsis Asia

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300

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2017-06-01

2018-05-31

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The first phase will be to examine urine samples obtained from patients with primary forms of cancer (untreated) and age matched controls ranging from 20-85. Depending on the screening criteria, patients who have been treated will be included in the screening procedure to determine if the platform can detect recurrence. As this platform is proposed for use with multiple forms of cancer, the inclusion criteria will be similar/identical among all patients. The cancers to be tested include 1) Lung and Bronchus; 2) Stomach; 3) Breast; 4) Esophagus; 5) Liver; 6) Colorectum; 7) Prostate; and 8) other cancers depending on disease prevalence and clinical access. 1. Patients must be >20 years of age; 2. Patients should have untreated, diagnosed forms of cancer (patients include newly diagnosed cancers and relapses greater than 6 months since the last intervention); 3. Patents must be mentally competent to make informed consent; 4. Patients must provide written informed consent and be willing to comply with the requirements of the protocol.；

1. Inability to provide informed consent; 2. Concurrent use or receipt within the previous 5 months of any chemo-therapeutic drugs or irradiation to treat the cancer, or treatment with corticosteroids at a dose > 40 mg/day (Note: doses <40 mg/day are permitted and not considered to be an exclusion factor); 3. Serious cardiovascular disease under current treatment; 4. Untreated type I and II diabetes; 5. Urine glucose levels above 1.0 mmol/L, which may be indicative of other underlying diseases; 6. Serious infections (hospitalization) within the prior 3 months.；

Entopsis Asia

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