- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03882684
Role of Genomic Imprinting in Cancer Diagnosis
March 18, 2019 updated by: Bai Chunxue, Chinese Alliance Against Lung Cancer
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chunxue Bai, MD
- Phone Number: 18621170011
- Email: bai.chunxue@zs-hospital.sh.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200000
- Recruiting
- Zhongshan Hospital of Fudan University
-
Contact:
- Chunxue Bai, MD
- Phone Number: 18621170011
- Email: bai.chunxue@zs-hospital.sh.cn
-
Contact:
- Dawei Yang, MD
- Phone Number: 13564703813
- Email: yang_dw@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with suspicious cancer in Zhongshan Hospital from July 2017 till the end of this study.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
The loss of imprinting (LOI) and copy number variation (CNV) from biopsies will be tested by LiSen in-situ imprinting detection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity of imprinting cancer early detection
Time Frame: In the middle of the study, an average of 15 months
|
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
Time Frame: In the middle of the study, an average of 15 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of the sensitivity of the imprinting detection versus cytopathology
Time Frame: In the middle of the study, an average of 15 months
|
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
Time Frame: In the middle of the study, an average of 15 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Jelinic P, Shaw P. Loss of imprinting and cancer. J Pathol. 2007 Feb;211(3):261-8. doi: 10.1002/path.2116.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2017
Primary Completion (Anticipated)
March 31, 2019
Study Completion (Anticipated)
June 30, 2020
Study Registration Dates
First Submitted
March 18, 2019
First Submitted That Met QC Criteria
March 18, 2019
First Posted (Actual)
March 20, 2019
Study Record Updates
Last Update Posted (Actual)
March 20, 2019
Last Update Submitted That Met QC Criteria
March 18, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAALC-005-LiSen
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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