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Oncotype DX DCIS: Impact on Radiotherapy Decision Making

NCT06046664 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-09-21

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-07
Primary Completion
2023-10-01
Completion
2023-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06046664 on ClinicalTrials.gov