Breast Cancer Clinical Trial
— ONCOTYPEOfficial title:
A Study Assessing the Impact of the Oncotype DX DCIS Score on Radiotherapy Decision Making in the United Kingdom
Verified date | September 2023 |
Source | Royal Marsden NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective single centre study of patients with DCIS that have undergone breast conservation surgery.
Status | Active, not recruiting |
Enrollment | 78 |
Est. completion date | December 31, 2023 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Royal Marsden NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Royal Marsden NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Secondary | 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) | |
Secondary | 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). | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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