NCT06789341

Brief Summary

This is an observational, retrospective, case-control, single-center, national study that involves the collection of anamnestic, clinical and therapeutic data of patients diagnosed with gastric cancer by histological examination at the Pathological Anatomy Unit (Prof. D'Errico) in the period 2016-2020.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

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 20, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
Last Updated

January 23, 2025

Status Verified

October 1, 2024

Enrollment Period

1.9 years

First QC Date

January 17, 2025

Last Update Submit

January 17, 2025

Conditions

Gastric Cancer Patient

Keywords

gastric cancer, helicobacter pylori

Outcome Measures

Primary Outcomes (1)

  • Collection of data

    The main objective of the study is to create a collection of clinical and laboratory data that will allow us to describe the incidence of gastric cancer in our center and to identify risk factors associated with the disease (H. pylori infection, smoking, alcohol, diet and BMI).

    2016-2020

Secondary Outcomes (1)

  • Data interaction in the developement of gastric cancer

    2016-2020

Eligibility Criteria

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

Saranno considerati eleggibili ad entrare nella raccolta dati tutti i pazienti con diagnosi di carcinoma gastrico (casi) o che abbiano effettuato un esame istologico gastrico (controlli) rilevati nell'archivio elettronico dell'istituto di anatomia patologica dal 2016 al 2020.

You may qualify if:

  • Età \> 18 anni.
  • Diagnosi istologica di carcinoma gastrico
  • Ottenimento del consenso informato.
  • Età \> 18 anni.
  • Esecuzione di indagine endoscopica gastrica con relativo esame istologico (mucosa sana, gastrite acuta, gastrite cronica con o senza infezione da Helicobacter pylori, metaplasia intestinale)
  • Ottenimento del consenso informato.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, 40138, Italy

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Giulia Fiorini, MD, PhD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 23, 2025

Study Start

January 20, 2022

Primary Completion

December 28, 2023

Study Completion

December 28, 2023

Last Updated

January 23, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)