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Completed

NCT Number: NCT06789341

Retrospective Data Collection for a Correlation Study Between Gastric Cancer and Clinical and Laboratory Variables

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, 40138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: HP-RETROSS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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