NCT06696963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
524

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

1 month

First QC Date

November 17, 2024

Last Update Submit

November 17, 2024

Conditions

Gastric Cancer

Keywords

Gastric cancerNeoadjuvant chemotherapyAdjuvant chemotherapyTime to chemotherapysurvival

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. FACS

Study Record Dates

First Submitted

November 17, 2024

First Posted

November 20, 2024

Study Start

March 15, 2024

Primary Completion

April 15, 2024

Study Completion

April 17, 2024

Last Updated

November 20, 2024

Record last verified: 2024-11

Locations

CN(1)