Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04830618
Status:
COMPLETED
Last Update Posted:
2021-04-05
First Post:
2021-03-31
Brief Title:
Aberrant DNA Methylation to Predict Metachronous Gastric Neoplasms
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Aberrant DNA Methylation Maker for Predicting Metachronous Recurrence After Endoscopic Resection of Gastric Neoplasms
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None