Research with human participants

Overview of medical research in the Netherlands

Early diagnosis of breast cancer:
A multicenter, crOss sectional, study to assess microRNA expression in Nipple Aspirate Fluid, blood and tuMor material in women with primary brEast caNcer compared with healthy conTrols
The ORNAMENT study

Published:
Last updated:

The validation of microRNA expression for screening and prevention of breast cancer

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Ethical review
Approved WMO
Status
Completed
Health condition type
Breast neoplasms malignant and unspecified (incl nipple)
Study type
Observational invasive

ID

NL-OMON50271

Source

ToetsingOnline

Brief title

Early diagnosis of breast cancer

Condition

  • Breast neoplasms malignant and unspecified (incl nipple)

Synonym

breast cancer, breast carcinoma

Research involving

Human

Sponsors and support

Primary sponsor :
Universitair Medisch Centrum Utrecht
Source(s) of monetary or material Support :
Stichting vrienden UMC Utrecht

Intervention

Keyword :
Biomarkers, Breast cancer, microRNA

Outcome measures

Primary outcome

To compare microRNA expression in nipple fluid from the cancerous breast to

microRNA expression in nipple fluid from the contralateral breast, the tumor

material obtained at surgery and blood from the same patient.

Secondary outcome

To assess the microRNA expression levels in nipple fluid obtained just before

treatment. This will be compared to the microRNA expression levels in nipple

fluid already obtained from healthy controls.

Background summary

Breast cancer is the leading cause of cancer death in women in the Western
world. In The Netherlands, the incidence is about 15.000 per year. Regular
screening is offered to high risk women, but breast tumors is still missed by
these screening modalities. At present there is no method to adequatly predict
who of the high-risk women will develop breast cancer en who will not. This
highlights the need for a novel, non-invasive and accessible screening tool
that enables detection of breast cancer in its earliest stages.

Study objective

The validation of microRNA expression for screening and prevention of breast
cancer

Study design

Multicenter cross-sectional observational study

Study burden and risks

An earlier study showed that the burden associated with nipple fluid aspiration
is minimal and the procedure is well tolerated. To further minimalize any
discomfort, nipple fluid will as much as possible be collected at the time of
regular visits to the hospital or outpatient clinic. The risks of the procedure
are negligible.

Public
Universitair Medisch Centrum Utrecht

Heidelberglaan 100
Utrecht 3584 CX
NL
Scientific
Universitair Medisch Centrum Utrecht

Heidelberglaan 100
Utrecht 3584 CX
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Female age >=18 years
histologically proven invasive breast carcinoma

Exclusion criteria

Bilateral breast reduction with nipple graft
Bilateral ablative breast surgery
Pregnancy or lactation
Active breast infection
Having disseminated breast cancer

Design

Study type :
Observational invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Prevention

Recruitment

NL
Recruitment status
:
Completed
Start date (anticipated) :
Enrollment :
200
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC NedMec
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC NedMec
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC NedMec
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC NedMec
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC NedMec

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

ID: 28422
Source: NTR
Title: Early detection of breast cancer using markers in nipple aspirate fluid, blood, and tumor material from women with breast cancer compared to healthy women.

In other registers

Register ID
Other 6162
CCMO NL57343.041.16
OMON NL-OMON28422