Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335576
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-22
Brief Title:
Establishment of Serum Proteomics Subtypes of Gastric Cancer and Its Clinical Application
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
Establishment of Serum Proteomics Subtypes of Gastric Cancer and Its Clinical
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
This study is a prospective single-center observational study aimed at detecting the status of serum protein profiles at key time points in gastric cancer patients receiving neoadjuvant therapy for advanced disease and constructing a serum protein model for evaluating the efficacy of neoadjuvant therapy for gastric cancer Subjects will receive neoadjuvant therapy treatment regimen determined by the primary physician limited to systemic therapy with options including immune checkpoint inhibitor-based regimens and non-immune checkpoint inhibitor-based regimens After four cycles of treatment the efficacy will be assessed Patients eligible for R0 resection will undergo D2 radical surgery regardless of tumor regression while those ineligible for R0 resection will enter the palliative treatment phase Note Subjects are all patients who require neoadjuvant therapy even if they do not participate in this clinical study Patients will receive regular follow-up evaluations for metastasisrecurrence and survival until tumor recurrenceprogression or the last known date of patient survival Note Regular follow-up in this study follows the frequency of routine clinical follow-ups The primary endpoint is progression-free survival PFS and the secondary endpoint is pathological response rate based on Becker tumor regression grading with residual tumor less than 50 considered effective preoperative treatment
Peripheral venous blood samples will be collected before the start of neoadjuvant therapy blood sampling point 1 - baseline and before surgery after neoadjuvant therapy blood sampling point 2 - post-treatment Approximately 3 ml of blood will be collected each time and about 15 ml of serum will be obtained after processing Serum protein profiling will be conducted to assess the expression of protein profiles at these treatment time points
Peripheral venous blood samples will be collected before the start of neoadjuvant therapy blood sampling point 1 - baseline and before surgery after neoadjuvant therapy blood sampling point 2 - post-treatment Approximately 3 ml of blood will be collected each time and about 15 ml of serum will be obtained after processing Serum protein profiling will be conducted to assess the expression of protein profiles at these treatment time points
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