NCT06800599

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
142mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
May 2022Dec 2037

Study Start

First participant enrolled

May 1, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2037

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2037

Last Updated

January 30, 2025

Status Verified

October 1, 2024

Enrollment Period

15.7 years

First QC Date

November 28, 2024

Last Update Submit

January 28, 2025

Conditions

Genetic Predisposition to Cancer

Outcome Measures

Primary Outcomes (1)

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

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

    15 years

Secondary Outcomes (1)

  • Possibility of conducting studies targeted at specific objectives

    15 years

Study Arms (2)

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.

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All users attending Oncology Genetics outpatient clinics will be registered. The user population of these outpatient clinics includes all patients assessed for hereditary cancer risk regardless of age, gender, disease status and genetic testing. The register will include both the proband, i.e. the first person in the family to undergo an oncological genetic assessment, and any family members who perform the assessment subsequently.

You may qualify if:

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

You may not qualify if:

  • misdiagnosis of oncological counselling during oncological genetic counselling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bologna, Italy, 40138, Italy

Location

Study Officials

  • Daniela Turchetti, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2024

First Posted

January 30, 2025

Study Start

May 1, 2022

Primary Completion (Estimated)

December 31, 2037

Study Completion (Estimated)

December 31, 2037

Last Updated

January 30, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)