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Prospective single centre study of patients with DCIS that have undergone breast conservation surgery.
This is a single centre (Royal Marsden Hospital - Chelsea and Sutton) non-randomised trial investigating whether the Oncotype DX DCIS score changes the radiotherapy recommendation made by clinical oncologists in patients with low to moderate risk DCIS following breast conserving surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCIS Test | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONCOTYPE DX DCIS test | Diagnostic Test | The Oncotype DX DCIS score, comprised of 12 of the 21 genes of the Oncotype DX Recurrence score, has been developed by Genomic Health Inc. Two clinical utility studies have now been performed in USA, assessing the value of the Oncotype DX DCIS to clinical decision making (18,19) The first study by Alvarado et al. evaluated the influence of the test in 10 centres and in 115 patients (18). The DCIS score led to a change in the treatment recommendation in 36 patients (31.3%; 26 patients had a change to no radiation and 10 patients had a change to recommend radiation). The second study similarly showed change in recommendations following the Oncotype DX DCIS test in 26.4% of cases. It is unclear what the impact of the DCIS score test would be in the UK. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in radiotherapy recommendation by clinician | Percentage of clinical oncology recommendations regarding radiotherapy that change pre- and post- Oncotype DX DCIS. | end of trial (2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Determine whether the Oncotype DX DCIS score results in a change in patient decision for adjuvant radiotherapy. | Percentage of patients who change their decision regarding radiotherapy pre- and post- Oncotype DX DCIS. | end of trial (2 years) |
| Determine whether the local recurrence risk estimated by clinical oncologists agrees with the local recurrence risk calculated by the Oncotype DX DCIS score (for all recurrences and for invasive recurrences only). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Marsden NHS Foundation Trust | London | SW3 6JJ | United Kingdom |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Agreement between the local recurrence risk estimated by clinical oncologists and the local recurrence risk calculated by the Oncotype DX DCIS score (for all recurrences and for invasive recurrences only). |
| end of trial (2 years) |
| Determine change in patient decisional conflict pre and post Oncotype DX DCIS. | Change in patient decisional conflict scale (DCS) scores pre and post Oncotype DX DCIS | end of trial (2 years) |
| Determine change in patient anxiety pre and post Oncotype DX DCIS. | Change in state anxiety and trait anxiety scores using the State Trait Anxiety Inventory (STAI) pre and post ONCOTYPE DX DCIS test | end of trial (2 years) |
| Determine patient, tumour and clinician factors that are associated with clinicians changing their decision regarding radiotherapy. | Patient, tumour and clinician factors (data collected during Visit 1) that are associated with clinicians changing their decision regarding radiotherapy. | end of trial (2 years) |
| Determine patient, tumour and clinician related factors that are associated with patients changing their decision regarding radiotherapy. | Patient, tumour and clinician related factors (data collected during Visit 1) that are associated with patients changing their decision regarding radiotherapy. | end of trial (2 years) |
| Determine patient, tumour and clinician related factors that are associated with patients' final decision to have radiotherapy. | Patient, tumour and clinician factors that are associated with patients' final decision to have radiotherapy. | end of trial (2 years) |
| D017437 |
| Skin and Connective Tissue Diseases |