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| Name | Class |
|---|---|
| LiSen Imprinting Diagnostic Inc. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer patients | The patients receive the surgery according to the indication of surgery. The diagnosis is confirmed by pathology of removed tissue. The result of imprinting detection are used as cancer group. |
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| Benign tumor and other disease patients | Patients ruled out the possibility of malignancy according to biopsy pathology are used as negative control. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-situ imprinting detection | Diagnostic Test | The loss of imprinting (LOI) and copy number variation (CNV) from biopsies will be tested by LiSen in-situ imprinting detection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of imprinting cancer early detection | Number of patients "declared positive" with the imprinting early detection among the patients suffered from cancer | In the middle of the study, an average of 15 months |
| Specificity of imprinting cancer early detection | Number of patients "declared negative" with the imprinting early detection among the patients who are with benign tumors or other diseases | In the middle of the study, an average of 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the sensitivity of the imprinting detection versus cytopathology | Number of patients "declared positive" with the imprinting early detection versus patients "declared positive" with the cytopathology | In the middle of the study, an average of 15 months |
| Comparison of the specificity of the imprinting detection versus cytopathology |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with suspicious cancer in Zhongshan Hospital from July 2017 till the end of this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunxue Bai, MD | Contact | 18621170011 | bai.chunxue@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29617578 | Background | Feinberg AP. The Key Role of Epigenetics in Human Disease Prevention and Mitigation. N Engl J Med. 2018 Apr 5;378(14):1323-1334. doi: 10.1056/NEJMra1402513. No abstract available. | |
| 17177177 | Background | Jelinic P, Shaw P. Loss of imprinting and cancer. J Pathol. 2007 Feb;211(3):261-8. doi: 10.1002/path.2116. |
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| ID | Term |
|---|---|
| D004194 | Disease |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This study collects biopsies samples including but not limited to bronchoscopy biopsy, bronchial lavage fluid, fine needle aspiration, cystoscopy biopsy, urine samples, colonoscopy biopsy.
Number of patients "declared negative" with the imprinting early detection versus patients "declared negative" with the cytopathology |
| In the middle of the study, an average of 15 months |
| 26056362 | Background | Haig D. Maternal-fetal conflict, genomic imprinting and mammalian vulnerabilities to cancer. Philos Trans R Soc Lond B Biol Sci. 2015 Jul 19;370(1673):20140178. doi: 10.1098/rstb.2014.0178. |
| 29302578 | Background | Nilendu P, Sharma NK. Epigenomic Hard Drive Imprinting: A Hidden Code Beyond the Biological Death of Cancer Patients. J Cancer Prev. 2017 Dec;22(4):211-218. doi: 10.15430/JCP.2017.22.4.211. Epub 2017 Dec 30. |
| 21262060 | Background | Uribe-Lewis S, Woodfine K, Stojic L, Murrell A. Molecular mechanisms of genomic imprinting and clinical implications for cancer. Expert Rev Mol Med. 2011 Jan 25;13:e2. doi: 10.1017/S1462399410001717. |