Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 8:18 AM
Study NCT ID:
NCT04520295
Status:
UNKNOWN
Last Update Posted:
2020-08-20
First Post:
2020-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ctDNA Screening in Advanced HER2 Positive Gastric Cancer
Sponsor:
Ruijin Hospital
Organization:
Study Overview
Official Title:
Predictive Biomarkers Screening by ctDNA Detection in Advanced HER2 Positive Gastric Cancer Patients Treated by Trastuzumab Plus Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
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:
To identify molecular biomarker panel correlating with efficacy of trastuzuamb in advanced HER2 positive gastric cancer patients. To observe the molecular evolution of HER2 positive gastric cancer during treatment by ctDNA detection.
Detailed Description:
Molecular events including gene mutation, fusion and amplification will be detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from peripheral blood samples of gastric cancer patients. For HER2 positive patients, samples will be collected at baseline, first surveillance after treatment and disease progression. For HER2 negative patients, samples will be collected at baseline as negative control.
Study Oversight
Has Oversight DMC:
True
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?: