Retrospective Data Collection for a Correlation Study Between Gastric Cancer and Clinical and Laboratory Variables (HP-RETROSS)

January 17, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
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.

Study Overview

Status

Completed

Conditions

Detailed Description

The corresponding medical records will be analyzed to derive information on the socio-demographic characteristics and risk factors of the included subjects. Each case will be paired with two controls chosen from patients who have performed a gastric biopsy with relative histological examination during an endoscopic examination carried out at the IRCCS Azienda Ospedaliero-Universitaria of Bologna.

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria cases:

  • Età > 18 anni.
  • Diagnosi istologica di carcinoma gastrico
  • Ottenimento del consenso informato.

Inclusion criteria controls:

  • 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.

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collection of data
Time Frame: 2016-2020
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data interaction in the developement of gastric cancer
Time Frame: 2016-2020
The secondary objective of the study is to know, analyze and describe the data collected in order to evaluate their possible interaction on the development of gastric neoplastic pathology, and to design a future prospective case-control study.
2016-2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Giulia Fiorini, MD, PhD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2022

Primary Completion (Actual)

December 28, 2023

Study Completion (Actual)

December 28, 2023

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 17, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-RETROSS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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