NCT05559229

Brief Summary

Alpha-fetoprotein (AFP) can become elevated in hepatocellular carcinoma (HCC), yolk sac tumors and other malignant tumors of various organs. Herein, the investigator present a case of AFP-producing gallbladder carcinoma with signet ring cells successfully treated with laparoscopic whole-layer cholecystectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

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 15, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 19, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

1.4 years

First QC Date

September 19, 2022

Last Update Submit

September 24, 2022

Conditions

Gallbladder Cancer

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy of measuring value of AFP for patients with gallbladder cancer.

    1 year

Interventions

laparoscopic whole-layer cholecystectomyPROCEDURE

laparoscopic whole-layer cholecystectomy.

Eligibility Criteria

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

a case of AFP-producing gallbladder carcinoma with signet ring cells

The study eligibility criteria for patient were as follows: AFP-producing gallbladder carcinoma (cT2aN0M0, cStage IIa, UICC 8th) or gallbladder metastasis from HCC.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

oita Red Cross hospital

Ōita, Oita Prefecture, 8700033, Japan

Location

MeSH Terms

Conditions

Gallbladder Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 19, 2022

First Posted

September 29, 2022

Study Start

January 15, 2021

Primary Completion

June 25, 2022

Study Completion

September 18, 2022

Last Updated

September 29, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)