Biomarker, Cancer, Early Diagnosis, Genomic Imprinting
Conditions
Brief summary
The current research focus for cancer diagonosis is classical genetics, named driving genes. However, not all cancer patients have typical genetic alterations, especially at early stage. In the past dacades, accumulating evidences have revealed that more than 80% diseases are closely related to epigenetic changes. The normally silenced copy of imprinted genes are reactivated at early stage of cancers, and finally proceed to copy number variation. This study will screen for a panel of imprinted genes and build quantitative models to assist the diagnosis of multiple cancers.
Interventions
DIAGNOSTIC_TESTIn-situ imprinting detection
The loss of imprinting (LOI) and copy number variation (CNV) from biopsies will be tested by LiSen in-situ imprinting detection.
Sponsors
LiSen Imprinting Diagnostic Inc.
Chinese Alliance Against Lung Cancer
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients diagnosed with suspicious cancer by ultrasound, CT or endoscope. * Biopsy samples available. * Male or female patients aged ≥ 18 years. * Participants signed informed consent form.
Exclusion criteria
* Age under 18 years. * Severe cardiovascular diseases. * Central nervous system diseases. * Mental disorder. * Pregnant. * Individuals unwilling to sign the IRB-approved consent form and unwilling to follow the protocol to submit the serial urine for test after surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of imprinting cancer early detection | In the middle of the study, an average of 15 months | Number of patients declared positive with the imprinting early detection among the patients suffered from cancer |
| Specificity of imprinting cancer early detection | In the middle of the study, an average of 15 months | Number of patients declared negative with the imprinting early detection among the patients who are with benign tumors or other diseases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the sensitivity of the imprinting detection versus cytopathology | In the middle of the study, an average of 15 months | Number of patients declared positive with the imprinting early detection versus patients declared positive with the cytopathology |
| Comparison of the specificity of the imprinting detection versus cytopathology | In the middle of the study, an average of 15 months | Number of patients declared negative with the imprinting early detection versus patients declared negative with the cytopathology |
Countries
China
Contacts
Primary ContactChunxue Bai, MD
Outcome results
None listed