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Influence of polygenic risk scores on CanRisk-based risk calculation for breast and ovarian cancer in healthy relatives of non-informatively tested index individuals

Influence of polygenic risk scores on CanRisk-based risk calculation for breast and ovarian cancer in healthy relatives of non-informatively tested index individuals - PRS-CHANCE

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00037226
Enrollment
800
Registered
2025-12-09
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

C50

Interventions

Group 1: Survey of the PRS (polygenic risk score) of relatives of non-informatively tested index individuals

Sponsors

Zentrum Familiärer Brust- und Eierstockkrebs Uniklinik Köln
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 45 Years

Inclusion criteria

Inclusion criteria: - Families fulfill the inclusion criteria of the DK-FBREK (see DKG checklist) - Index person is non-informative tested by gene panel analysis. - The person seeking advice has no personal history of breast or ovarian cancer - No other acute, palliative or prognosis-relevant (oncological) disease in personal medical history - First to second degree of kinship (relationship coefficient R = 1/4) to a family member with breast or ovarian cancer - Age between 30 and 50 years (in this age range, inclusion in intensified breast cancer screening is possible in accordance with special care under Section 140a SGB 5) - A possible 2nd genetic line has been excluded or clarified with an index test by gene panel analysis, which resulted in a non-informative genetic finding - Consent to HerediCaRe and to the genetic analysis has been given or will be given as part of the study inclusion

Exclusion criteria

Exclusion criteria: - not fulfilling the above inclusion criteria - lack of capacity to consent - lack of consent - Condition after bilateral mastectomy

Design outcomes

Primary

MeasureTime frame
Risk change for breast cancer (long time risk and 10 years risk) and any associated “category change” (a change in the risk category and thus the recommendation regarding participation in intensified breast cancer screening).

Secondary

MeasureTime frame
The secondary objective is an exploratory description of the change in risk of ovarian cancer (long time risk in %)

Countries

Germany

Contacts

Public ContactLisa Richters

Zentrum Familiärer Brust- und Eierstockkrebs Uniklinik Köln

lisa.richters@uk-koeln.de0221/478-37531

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026