Role of Genomic Imprinting in Cancer Diagnosis

Cancer Clinical Trial

Official title:

Role of Genomic Imprinting in Cancer Diagnosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03882684
• Other study ID #: CAALC-005-LiSen
• Status: Recruiting
• Start date: July 1, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: March 2019
• Source: Chinese Alliance Against Lung Cancer
• Contact: Chunxue Bai, MD
• Phone: 18621170011
• Email: bai.chunxue[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: June 30, 2020
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biomarker
• Cancer
• Early Diagnosis
• Genomic Imprinting

Intervention

Diagnostic Test:
• In-situ imprinting detection
The loss of imprinting (LOI) and copy number variation (CNV) from biopsies will be tested by LiSen in-situ imprinting detection.

Locations

Country	Name	City	State
China	Zhongshan Hospital of Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Alliance Against Lung Cancer	LiSen Imprinting Diagnostic Inc.

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Review. — View Citation

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). pii: 20140178. doi: 10.1098/rstb.2014.0178. Review. — View Citation

Jelinic P, Shaw P. Loss of imprinting and cancer. J Pathol. 2007 Feb;211(3):261-8. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Comparison of the specificity of the imprinting detection versus cytopathology	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