Single-institution Register of Individuals Undergoing Cancer Genetic Risk Assessment

NCT ID: NCT06800599

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 7000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2037-12-31

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.

Conditions

Genetic Predisposition to Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Prospective

During oncology genetic counselling, together with the standard forms usually applied, the information sheet concerning participation in the register will also be sent to users who meet the inclusion criteria.

No interventions assigned to this group

Retrospective

For patients who underwent oncological genetic counselling before the start of the registry, retrospective recruitment will be carried out by means of re-contact for the purpose of proposing joining the registry.

No interventions assigned to this group

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniela Turchetti, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Bologna, Italy, Italy

Countries

Italy

Other Identifiers

REGIO

Identifier Type: -

Identifier Source: org_study_id