Impact of TTC Following Neoadjuvant Chemotherapy on the P... | NCT06696963

Studies
Impact of TTC Following Neoadjuvant Chemotherapy on the Prognosis of LAGC

NCT06696963

Sponsor

Fujian Medical University

Status

Completed

Last Update Posted

Nov 20, 2024Actual

Enrollment

524Actual

Phase

Not provided

Conditions

Gastric Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2022QNA026	Other Grant/Funding Number	Fujian Medical University Union Hospital

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2024Actual

Primary Completion Date

Apr 15, 2024Actual

Completion Date

Apr 17, 2024Actual

First Submitted Date

Nov 17, 2024

First Submission Date that Met QC Criteria

Nov 17, 2024

First Posted Date

Nov 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2024

Last Update Posted Date

Nov 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

he present study retrospectively analyzed the clinicopathological data of 524 patients diagnosed with LAGC who underwent D2 radical gastrectomy after NACT between January 2010 and December 2021 at 2 centers. This study was conducted in accordance with the ethical principles outlined in the World Medical Association's Declaration of Helsinki. Informed consent was obtained from all patients and their legal guardians. All procedures were approved by the institutional review board.

Detailed Description

This is a retrospective, multicenter study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

524Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
3-year all-caused mortality, 3-year Gastric-Cancer Specific Motality	Survival status at 3 years: survival, death, survival with tumor	3 years or 36 months.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(1) Locally advanced gastric cancer with preoperative clinical staging of cT2-4NxM0 before neoadjuvant chemotherapy. (2) No history of other malignant tumors. (3) No evidence of distant metastasis or invasion of adjacent organs. (4) Underwent gastrectomy after receiving neoadjuvant chemotherapy.

Exclusion Criteria:

(1) History of prior gastrectomy. (2) History of acute cardiovascular diseases (such as cerebral or coronary artery injuries) within the past three months. (3) Emergency surgery. (4) Did not undergo postoperative adjuvant chemotherapy. (5) Lack of specific information regarding chemotherapy regimens. (6) Loss to follow-up.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

84 Years

Standard Ages

AdultOlder Adult

Study Population

Locally Advnced Gastric Cancer who underwent D2 radical gastrectomy after NACT between January 2010 and December 2021

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fujian Medical University Union Hospital		Fuzhou	Fujian	350001	China

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided