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Single-institution Register of Individuals Undergoing Cancer Genetic Risk Assessment

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06800599
Enrollment
7000
Registered
2025-01-30
Start date
2022-05-01
Completion date
2037-12-31
Last updated
2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetic Predisposition to Cancer

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.

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
Register and follow up over time individuals assessed for suspected genetic predisposition to cancer15 yearsRegister and follow up over time individuals assessed for suspected genetic predisposition to cancer

Secondary

MeasureTime frameDescription
Possibility of conducting studies targeted at specific objectives15 yearsAcquire 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026