Aberrant DNA Methylation to Predict Metachronous Gastric Neoplasms

March 31, 2021 updated by: Dong Ho Lee, Seoul National University Hospital

Aberrant DNA Methylation Maker for Predicting Metachronous Recurrence After Endoscopic Resection of Gastric Neoplasms

The study is a prospective cohort study to investigate whether aberrant DNA methylation can be useful for the prediction of metachronous recurrence after endoscopic resection of gastric neoplasms (dysplasia or cancer). From 2012 to 2017, 300 patients were prospectively enrolled after endoscopic resection (ER) of gastric dysplasia or early gastric cancer. All lesions were assessed by endoscopy and biopsy before ER. Endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) was performed for gastric dysplasia and early gastric cancers which met the absolute indication (differentiated adenocarcinoma, intramucosal cancer, lesions < 20 mm, and no endoscopic evidence of ulceration). All lesions were curatively resected; if non-curatively resected, the patients were not enrolled from the study. All subjects, who provided informed consent, were asked to complete a questionnaire under the supervision of a well-trained interviewer. The questionnaire included questions regarding demographic data (age, sex), socioeconomic data (smoking, alcohol, and education), their family history of GC in first-degree relatives, and history of H. pylori eradication therapy. Also, MOS methylation level at baseline was measured from noncancerous gastric mucosae at corpus. When H. pylori was positive by CLOtest or histology at baseline or during the follow-up, eradication therapy was done. To evaluate whether H. pylori was eradicated, 13C-urea breath testing was performed at least 4 weeks after completion of the eradication therapy. All study subjects were closely followed up since recurrent tumors at previous endoscopic resection sites can be easily detected on endoscopy with biopsy and treated during follow-up. Patients with local recurrence underwent further treatments, including repeated ESD, APC, and gastrectomy based on pathology, and patients who refused treatment received supportive care. All patients underwent endoscopy with biopsy within 6 months, then at 12 months after ESD to check for metachronous lesions or local recurrences. After 12 months, endoscopy with biopsy was performed annually. In case of EGCs, abdominal CT scan was performed in the first year and biennially thereafter to detect lymph node or distant metastases. The definition of the completion of the study protocol was 1) endoscopic and/or radiologic follow-up for more than 3 years, or 2) development of metachronous gastric neoplasm (primary outcome: gastric dysplasia or cancer) during the follow-up. Metachronous recurrence was defined as secondary dysplasia or cancers detected > 1 year after initial diagnosis.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

300

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with gastric neoplasms (gastric dysplasia or early gastric cancer) which was curatively resected endoscopically.

Description

Inclusion Criteria:

  • Patients who underwent endoscopic resection of gastric neoplasms (dysplasia or early gastric cancer)
  • All gastric neoplasms at diagnosis should be curatively resected before enrollment.

Exclusion Criteria:

  • Previous history of all cancers.
  • Previous history of gastrectomy
  • Non-curative resection of gastric neoplasms
  • Refusal to consent

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metachronous recurrence
Time Frame: at least > 1 year after enrollment (initial diagnosis), from enrollment to Dec 2020
Metachronous recurrence was defined as secondary dysplasia or cancers detected > 1 year after initial diagnosis.
at least > 1 year after enrollment (initial diagnosis), from enrollment to Dec 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

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

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)

September 11, 2012

Primary Completion (Actual)

November 16, 2017

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria

March 31, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 5, 2021

Last Update Submitted That Met QC Criteria

March 31, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1204/152-004

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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