Clinical trial · Interventional
Oncotype DX DCIS: Impact on Radiotherapy Decision Making
A Study Assessing the Impact of the Oncotype DX DCIS Score on Radiotherapy Decision Making in the United Kingdom
NCT06046664CI-TRIAL-00069816ONCOTYPEunknownN/AClinicalTrials.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)
Prospective single centre study of patients with DCIS that have undergone breast conservation surgery.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ONCOTYPE DX DCIS test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- DCIS Test
- interventionNames
- Diagnostic Test: ONCOTYPE DX DCIS test
Primary outcomes (1)
- measure
- Change in radiotherapy recommendation by clinician
- timeFrame
- end of trial (2 years)
- description
- Percentage of clinical oncology recommendations regarding radiotherapy that change pre- and post- Oncotype DX DCIS.
Secondary outcomes (7)
- measure
- Determine whether the Oncotype DX DCIS score results in a change in patient decision for adjuvant radiotherapy.
- timeFrame
- end of trial (2 years)
- description
- Percentage of patients who change their decision regarding radiotherapy pre- and post- Oncotype DX DCIS.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. Confirmed diagnosis of DCIS 2. DCIS treated with breast conserving surgery Exclusion Criteria: 1. Prior treatment for DCIS or invasive breast cancer in ipsilateral breast. 2. Patients with contra-indications to radiotherapy, including prior breast radiotherapy 3. Patients who undergo mastectomy for DCIS 4. Age \< 45 years old 5. Patients with \> 25mm DCIS 6. Patients with multifocal DCIS (defined as more than 1 distinct focus of DCIS with at least 50mm of intervening benign tissue) 7. Patients with invasive (including microinvasion) disease 8. Patients with positive axillary nodal disease (including isolated tumour cells) 9. Patients with close (\<1mm) or positive radial margins (unless maximally surgically excised or no further DCIS on re-excision) 10. Patients recommended adjuvant endocrine therapy
References
Publications (0)
Data not yet available
No reference posted for this study.