Clinical trial · Observational
Genetic Testing to Improve Management of Patients Undergoing Breast Biopsy
NCT06060561CI-TRIAL-00118202suspendedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): on hold for analysis
Summary
Brief summary (as posted)
This study evaluates genetic testing to improve risk assessment and advance efforts to develop precision management for breast cancer by studying saliva samples for genotyping and evaluate associations with pathologic diagnoses and detailed pathologic and radiologic features.
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 Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational
- description
- Patients undergo saliva sample collection and complete questionnaires on study. Patients' medical records are reviewed.
- interventionNames
- Other: Non-Interventional Study
Primary outcomes (5)
- measure
- Number of subjects consented per month
- timeFrame
- Baseline; Up to study completion (approximately 5 years)
- description
- Will be assessed by the percentage of eligible patients consented.
- measure
- Deoxyribonucleic acid (DNA) quantity
- timeFrame
- Up to study completion (approximately 5 years)
- description
- Will analyze DNA from saliva sample to assess quantity for a validated polygenic risk score (PRS) for breast cancer.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \* Women over the age of 18 years * Able to provide informed consent * Referred for a radiologically guided breast biopsy Exclusion Criteria: * \* Men * Women under the age of 18 years * Unable to provide informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.