The implementation of microarrays in cancer diagnosis (Microarray prognostics in breast cancer).

mRNA expression patterns as an aid in adjuvant systemic therapy decision making in lymph node negative breast cancer patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26188

Enrollment

750

Registered

2005-09-12

Start date

2004-01-22

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

Diagnostic intervention with the 70-gene microarray profile giving a result of 'high' or 'low' risk for distant metastasis and death.

Eligibility

Inclusion criteria

Inclusion criteria: Female patients with primary operable unifocal breast cancer without clinical signs of lymph node involvement or distant metastasis younger than 55 years of age.

Exclusion criteria

Exclusion criteria: A prior history of any malignancy with the exception of cervical dysplasia and basal cell carcinoma.

Design outcomes

Primary

Measure	Time frame
The amount of succesfully performed diagnostic microarray tests as a proportion of the total number of accrued patients.	—

Secondary

Measure	Time frame
1. To assess the proportion of a 'high' versus a 'low' risk profile in lymph node negative breast cancer patients; 2. To assess the concordance between the 70-gene microarray risk profile and the metastasis risk as assessed with current Dutch guidelines based on clinicopathological factors (such as age, pT, tumor grade, hormonal receptor-status).	—

Contacts

Public ContactS.C. Linn

Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Departments of Molecular Biology and Medical Oncology, Plesmanlaan 121

s.linn@nki.nl+31 (0)20 5122951

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)