Clinical trial NCT03882684: Role of Genomic Imprinting in Cancer Diagnosis
Official title: Role of Genomic Imprinting in Cancer Diagnosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Diagnosis
Cancer
Biomarker
Genomic Imprinting
Lead sponsor: Chinese Alliance Against Lung Cancer
Sponsor class: OTHER
Collaborators: name: LiSen Imprinting Diagnostic Inc.
First posted: 2019-03-20
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with suspicious cancer in Zhongshan Hospital from July 2017 till the end of this study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity of imprinting cancer early detection
timeFrame: In the middle of the study, an average of 15 months
measure: Specificity of imprinting cancer early detection
timeFrame: In the middle of the study, an average of 15 months
Secondary outcomes:
measure: Comparison of the sensitivity of the imprinting detection versus cytopathology
timeFrame: In the middle of the study, an average of 15 months
measure: Comparison of the specificity of the imprinting detection versus cytopathology
timeFrame: In the middle of the study, an average of 15 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
state: Shanghai
Study officials:
References:
citation: 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.
citation: Jelinic P, Shaw P. Loss of imprinting and cancer. J Pathol. 2007 Feb;211(3):261-8. doi: 10.1002/path.2116.
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):20140178. doi: 10.1098/rstb.2014.0178.
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.
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.