NCT03922230

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 19, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

April 19, 2019

Status Verified

February 1, 2019

Enrollment Period

1.8 years

First QC Date

March 15, 2019

Last Update Submit

April 18, 2019

Conditions

Keywords

esophageal squamous cancerDNA methylolationearly screening

Outcome Measures

Primary Outcomes (1)

  • Hydroxymethylation level

    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.

    up to 2 years

Study Arms (3)

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.

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population comes from the Nanfang Hospital of Southern Medical University.

You may qualify if:

  • Diagnosis of esophageal squamous cell carcinoma by pathological cytology and histology.
  • 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).)
  • The normal population comes from the healthy population of Nanfang Hospital Health Center of Southern Medical University.

You may not qualify if:

  • Preoperative patients have received relevant treatment, such as radiotherapy and chemotherapy;
  • The subject has other diseases, such as tumors in other parts;
  • Patients do not meet the age;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral venous blood

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • kaican cai

    Nanfang Hospital, Southern Medical University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2019

First Posted

April 19, 2019

Study Start

March 1, 2019

Primary Completion

December 31, 2020

Study Completion

March 31, 2021

Last Updated

April 19, 2019

Record last verified: 2019-02

Locations