Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06800599

Single-institution Register of Individuals Undergoing Cancer Genetic Risk Assessment

Single-centre, retrospective, prospective observational cohort study, based on the registration of data from users of the Oncology Genetics Outpatient Clinic

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

Bologna, Italy, 40138

About this study

The primary objective of this study is to establish a register to collect and update over time the clinical, genetic and socio-demographic data of all patients who will be assessed for a suspected oncological genetic predisposition, in order to acquire information that can be used for conducting specific studies aimed at clarifying the various uncertainties that still characterise these diseases, such as the clinical significance and the genotype-phenotype correlations of many alterations in oncological predisposition genes oncological predisposition genes, the clinical and bio-pathological features predictive of a significant probability of identifying mutations in these genes, the efficacy of surveillance and prevention measures undertaken to reduce the risk oncological risk according to guidelines, the effectiveness of oncological therapies in patients with hereditary tumours in comparison with those with sporadic neoplasms sporadic neoplasms, risk perception, emotional impact and also interpersonal experiences associated with oncological genetic risk assessment.

These are objectives of primary interest to both the patient and public health (given the general frequency of oncological diseases), because the information acquired will make it possible to improve the general clinical management of all cancer patients and their families.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • participants aged 0 days or older at the time of genetic counselling
  • obtaining a signed informed consent

Exclusion criteria

  • misdiagnosis of oncological counselling during oncological genetic counselling

Treatment and study plan

Primary outcomes

  1. Register and follow up over time individuals assessed for suspected genetic predisposition to cancer

    Time frame: 15 years

    Register and follow up over time individuals assessed for suspected genetic predisposition to cancer

Secondary outcomes

  1. Possibility of conducting studies targeted at specific objectives

    Time frame: 15 years

    Acquire information that can be used for conducting specific studies aimed at clarifying the various uncertainties that still characterize these cancer diseases due to genetic predisposition

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Registro Mono-istituzionale Di Individui Sottoposti a Valutazione Del Rischio Genetico Oncologico

Important dates

Study start
2022
Primary completion
2037
Study completion
2037
First posted
Jan 30, 2025
Registry last updated
Jan 30, 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.

Published trials that share one or more normalized conditions with this study.