Role of Genomic Imprinting in Cancer Diagnosis

NCT ID: NCT03882684

Last Updated: 2019-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Early Diagnosis Cancer Biomarker Genomic Imprinting

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

In-situ imprinting detection

Intervention Type DIAGNOSTIC_TEST

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

Benign tumor and other disease patients

Patients ruled out the possibility of malignancy according to biopsy pathology are used as negative control.

In-situ imprinting detection

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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LiSen Imprinting Diagnostic Inc.

UNKNOWN

Sponsor Role collaborator

Chinese Alliance Against Lung Cancer

OTHER

Sponsor Role lead

Responsible Party

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Bai Chunxue

Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunxue Bai, MD

Role: CONTACT

18621170011

Facility Contacts

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Chunxue Bai, MD

Role: primary

18621170011

Dawei Yang, MD

Role: backup

13564703813

References

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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.

Reference Type BACKGROUND
PMID: 29617578 (View on PubMed)

Jelinic P, Shaw P. Loss of imprinting and cancer. J Pathol. 2007 Feb;211(3):261-8. doi: 10.1002/path.2116.

Reference Type BACKGROUND
PMID: 17177177 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26056362 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29302578 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21262060 (View on PubMed)

Other Identifiers

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CAALC-005-LiSen

Identifier Type: -

Identifier Source: org_study_id

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