NCT06046664

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

Prospective single centre study of patients with DCIS that have undergone breast conservation surgery.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_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.

Timeline

• Start date: 2020-07-07
• Primary completion: 2023-10-01
• Completion: 2023-12-31
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: United Kingdom