Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exploration and Verification of DNA Methylolation in Early Screening of Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03922230
Recruitment Status : Unknown
Verified February 2019 by Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aim of this study was to detect the whole genome hydroxymethylation of peripheral blood ct DNA in normal population, patients with p0~pI esophageal squamous cell carcinoma and pII~pIV esophageal squamous cell carcinoma by using DNA methylation detection technology. To compare the differences in genomic methylation levels between different groups, to find out the methylolation site system associated with early esophageal squamous cell carcinoma, and to verify the genes related to esophageal squamous cell carcinoma by ctDNA methylolation. Application of basicization in early screening of esophageal squamous cell carcinoma.

Condition or disease
Esophageal Squamous Cell Carcinoma

Detailed Description:
The aim of this study was to detect the whole genome hydroxymethylation of peripheral blood ct DNA in normal population, patients with p0~pI esophageal squamous cell carcinoma and pII~pIV esophageal squamous cell carcinoma by using DNA methylation detection technology. The differences in genomic methylation levels between different groups were compared to identify the methylolation site system associated with early esophageal squamous cell carcinoma. Then, using the genomic methylolation technique, 5hmC-DNA enrichment was performed on the peripheral venous blood samples of the experimental group before surgery and the peripheral venous blood samples of the control group, respectively, and then the high abundance and high significance were selected. The 5hmC-DNA fragment was verified by PCR amplification. The genes related to esophageal squamous cell carcinoma were verified by ctDNA methylolation. Finally, the methylolation genes related to esophageal squamous cell carcinoma were identified, and the application of DNA methylation in early screening of esophageal squamous cell carcinoma was explored.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Digestive Tract Tumor Research Based on ctDNA Methylation Detection Technology and Early Non-invasive Screening: Exploration and Verification of DNA Methylolation in Early Screening of Esophageal Cancer
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Early esophageal cancer group
Pathological examination diagnosed as Early esophageal cancer.The ratio of male to female is 3:1, and the age is between 50 and 70 years old.
Middle and advanced ES group
Pathological examination diagnosed as Middle and advanced esophageal cancer.
Normal group
Confirmed as the normal by health checkups.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Hydroxymethylation level [ Time Frame: up to 2 years ]
    To compare the differences in hydroxymethylation levels among patients in different groups, to identify the hydroxymethylation genes associated with esophageal squamous cell carcinoma, and to verify the genes related to esophageal squamous cell carcinoma by ctDNA hydroxymethylation.


Biospecimen Retention:   Samples With DNA
Peripheral venous blood

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Population comes from the Nanfang Hospital of Southern Medical University.
Criteria

Inclusion Criteria:

  1. Diagnosis of esophageal squamous cell carcinoma by pathological cytology and histology.
  2. Clinically judged patients with p0~pIV initial treatment.（1 Variable risk factors are overeating food (habits) and family history. 2 Among all the patients, the ratio of male to female is 3:1, and the age is between 50 and 70 years old. In addition to eating too hot food, other eating habits (such as eating fresh fruits and vegetables, eating preserved food, etc.) are consistent, other factors (such as BMI, smoking, drinking, etc.) as much as possible. 3 In order to rule out the interference of other diseases, each sample needs to be determined to have no history of other diseases (such as neurodegenerative diseases, leukemia).）
  3. The normal population comes from the healthy population of Nanfang Hospital Health Center of Southern Medical University.

Exclusion Criteria:

  1. Preoperative patients have received relevant treatment, such as radiotherapy and chemotherapy;
  2. The subject has other diseases, such as tumors in other parts;
  3. Patients do not meet the age;
  4. There is no guarantee that other eating habits (such as eating fresh fruits and vegetables, not eating preserved foods) and other factors (such as BMI, smoking, drinking, etc.) are basically the same.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922230


Contacts
Layout table for location contacts
Contact: kaican cai 13902205332 doc_cai@163.com

Locations
Layout table for location information
China, Guangdong
Nanfang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Kaican Cai, MD    8620-61641822    doc_cai@163.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
Layout table for investigator information
Study Director: kaican cai Nanfang Hospital of Southern Medical University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03922230    
Other Study ID Numbers: NFEC-2019-015
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nanfang Hospital of Southern Medical University:
esophageal squamous cancer
DNA methylolation
early screening
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Neoplasms
Esophageal Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases