Clinical trial · Observational
Universal Genetic Testing Versus Guidelines-Directed Testing for Germline Pathogenic Variants Among Non-Western Patients With Breast Cancer
NCT04920656CI-TRIAL-00087407completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study aims to examinethe pattern and frequency of pathogenic variants among all newly diagnosed breast cancer patients in a genetically distinct population. Additionally, the uptake rate of "cascade family screening" , frequency of pathogenic variants and barriers against testing will be studied.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Breast cancer patients
- description
- All adult patients with a confirmed diagnosis of breast cancer, aged 18 or older at time of cancer diagnosis, will be invited to participate.
Primary outcomes (3)
- measure
- Prevalence of pathogenic or likely pathogenic germline variants among newly diagnosed breast cancer patients tested by universal multigene panel testing or guideline-based targeted testing
- timeFrame
- 2021-2023
- measure
- Number of participants with variants of uncertain significance (VUS) as assessed by universal multigene panel testing versus guideline-based targeted testing
- timeFrame
- 2021-2023
- measure
- The reasons/ Barriers for refusal of genetic cascade testing among newly diagnosed cancer patients
- timeFrame
- 2021-2023
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patient, age ≥ 18 years at time of cancer diagnosis * Pathology proven diagnosis of breast cancer (including DCIS); any stage. (prior history of cancer is allowed) * Willingness to participate * Signed consent form. Exclusion Criteria: \- Major psychiatric disorder (defined as: patients followed by a psychiatrist and on antipsychotic medications
References
Publications (0)
Data not yet available
No reference posted for this study.