Role of Genomic Imprinting in Cancer Diagnosis

NCT03882684 | Unknown

• 1 other identifier: CAALC-005-LiSen
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Diagnosis; Cancer; Biomarker; Genomic Imprinting

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Comparison of the sensitivity of the imprinting detection versus cytopathology

  In the middle of the study, an average of 15 months

• Comparison of the specificity of the imprinting detection versus cytopathology

  In the middle of the study, an average of 15 months

Study Arms (2)

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.

Diagnostic Test: 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.

Diagnostic Test: In-situ imprinting detection

Interventions

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.

Benign tumor and other disease patients; Cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with suspicious cancer in Zhongshan Hospital from July 2017 till the end of this study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Alliance Against Lung Cancer: lead
• LiSen Imprinting Diagnostic Inc.: collaborator

Study Sites (1)

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related 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. No abstract available.

  PMID: 29617578 BACKGROUND

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

  PMID: 17177177 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.

  PMID: 26056362 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.

  PMID: 29302578 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.

  PMID: 21262060 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

This study collects biopsies samples including but not limited to bronchoscopy biopsy, bronchial lavage fluid, fine needle aspiration, cystoscopy biopsy, urine samples, colonoscopy biopsy.

MeSH Terms

Conditions

Disease; Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chunxue Bai, MD

CONTACT

18621170011; bai.chunxue@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 20, 2019
• Study Start: July 1, 2017
• Primary Completion: March 31, 2019
• Study Completion: June 30, 2020
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)