NCT05671393

Brief Summary

Due to lacking of evidence on surveillance for gastric neuroendocrine carcinoma (G-NEC), this study aimed to determine the optimal postsurgical surveillance strategy for G-NEC patients and compare its cost-effectiveness with traditional surveillance strategies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
801

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 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

January 1, 2008

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 31, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
Last Updated

January 4, 2023

Status Verified

December 1, 2022

Enrollment Period

8.9 years

First QC Date

December 31, 2022

Last Update Submit

December 31, 2022

Conditions

Gastric Neuroendocrine Carcinoma

Outcome Measures

Primary Outcomes (1)

  • recurrence rate

    distant, peritoneal, and local recurrence

    60 months

Secondary Outcomes (2)

  • Delayed-detection months

    60 months

  • Incremental cost-effectiveness ratios (ICERs)

    60 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 801 G-NEC patients from 21 centers in China were included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang-ming Huang

Fuzhou, Fujian, 350001, China

Location

Related Publications (1)

  • Xu BB, He XY, Zhou YB, He QL, Tian YT, Hao HK, Qiu XT, Jiang LX, Zhao G, Li Z, Xu YC, Fu WH, Xue FQ, Li SL, Xu ZK, Zhu ZG, Li Y, Li E, Chen JP, Li HL, Cai LS, Wu D, Li P, Zheng CH, Xie JW, Lu J, Huang CM. Optimal postoperative surveillance strategies for cancer survivors with gastric neuroendocrine carcinoma based on individual risk: a multicenter real-world cohort study. Int J Surg. 2023 Jun 1;109(6):1668-1676. doi: 10.1097/JS9.0000000000000401.

    PMID: 37076132DERIVED

Study Officials

  • Chang-ming Huang, MD

    Fujian Medical University Union Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of gastric surgery

Study Record Dates

First Submitted

December 31, 2022

First Posted

January 4, 2023

Study Start

January 1, 2008

Primary Completion

December 1, 2016

Study Completion

December 15, 2022

Last Updated

January 4, 2023

Record last verified: 2022-12

Locations

CN(1)