Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-30 @ 2:52 AM
Study NCT ID:
NCT06232395
Status:
RECRUITING
Last Update Posted:
2025-06-06
First Post:
2024-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Detection and Post-operative Monitoring of Gastric Cancer
Sponsor:
Suzhou Huhu Health & Technology Inc.
Organization:
Study Overview
Official Title:
Early Detection and Post-operative Monitoring of Gastric Cancer Using Circulating DNA in Blood Samples
Status:
RECRUITING
Status Verified Date:
2025-06
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:
This study is to determine the performance of non-invasive new multi-target biomarkers in the early detection and post-operative monitoring of gastric cancer.
Detailed Description:
This study aims to develop and validate a new non-invasive detection method for early detection and postoperative monitoring of gastric cancer in the blood. Sensitivity, specificity, accuracy, ROC curve area, positive predictive value, and negative predictive value of the new biomarkers in the diagnosis of gastric cancer will be compared with that of tumor biomarkers CA19-9, CEA, and CA72-4. Blood will also be collected at various time points post-operatively. The investigators will determine whether these new biomarkers can be used as prognostic biomarkers to predict tumor recurrence and metastasis. The investigators will also determine whether these new biomarkers detect tumor recurrence and metastasis earlier than methods currently used in the clinic such as imaging and tumor biomarkers CA19-9, CEA, and CA72-4.
This study is a prospective and multi-center study.
This study is a prospective and multi-center study.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: