Oncotype DX DCIS: Impact on Radiotherapy Decision Making
NCT ID: NCT06046664
Last Updated: 2023-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
78 participants
INTERVENTIONAL
2020-07-07
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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DCIS Test
ONCOTYPE DX DCIS 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.
Interventions
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ONCOTYPE DX DCIS 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.
Eligibility Criteria
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Inclusion Criteria
2. DCIS treated with breast conserving surgery
Exclusion Criteria
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
FEMALE
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Locations
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The Royal Marsden NHS Foundation Trust
London, , United Kingdom
Countries
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Other Identifiers
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CCR4963
Identifier Type: -
Identifier Source: org_study_id
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