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Clinical Trials/NCT06800599
NCT06800599Enrolling By InvitationNot Applicable

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

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 site in 1 country7,000 target enrollmentStarted: May 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
7,000
Locations
1
Primary Endpoint
Register and follow up over time individuals assessed for suspected genetic predisposition to cancer

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • Possibility of conducting studies targeted at specific objectives(15 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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