Skip to content

MULTICENTER FEASIBILITY STUDY OF THE SENTINEL NODE PROCEDURE IN PATIENTS WITH MULTIPLE BREAST TUMORS

MULTICENTER FEASIBILITY STUDY OF THE SENTINEL NODE PROCEDURE IN PATIENTS WITH MULTIPLE BREAST TUMORS - MULTISENT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON32855
Enrollment
50
Registered
2009-07-02
Start date
2009-05-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

breast cancer breast neoplasms

Interventions

None listed

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients presenting with multiple invasive tumors in one or more quadrants of the breast. The minimal distance between two different invasive foci must be two centimeters. The minimal diameter of an invasive focus (of one tumor) must be one centimeter.

Exclusion criteria

Exclusion criteria: The maximum diameter of an invasive focus (one tumor) must be five centimeters. The maximum number of present invasive foci in one breast must be three tumors. Evidence of other breast-cancer related disease such as palpable or ultrasound detected lymph node metastases or distant metastases. Exclusive presence of ductal carcinoma in situ (DCIS). Incapacity or unwillingness of participant to give written informed consent.

Design outcomes

Primary

MeasureTime frame
1. Number of sentinel nodes after first injection 2. Extra number of sentinel nodes after second injection 3. Different locations of sentinel nodes after first injection 4. Extra locations of sentinel nodes after second injection 5. Analysis of the possible differences in lymphatic drainage between patients with multifocal and multicentric tumors

Secondary

MeasureTime frame
1. Lymph node recurrences 2. Overall and disease-free survival

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)