|- candidate number||25651|
|- NTR Number||NTR6162|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-dec-2016|
|- Secondary IDs||NL57343.041.16 METC University Medical Center Utrecht |
|- Public Title||Early diagnosis of breast cancer: A monocenter, crOss sectional, study to assess microRNA expression in Nipple Aspirated Fluid, blood and tuMor material in women with primary brEast caNcer compared with healthy conTrols. The ORNAMENT study
|- Scientific Title||Early diagnosis of breast cancer: A monocenter, crOss sectional, study to assess microRNA expression in Nipple Aspirated Fluid, blood and tuMor material in women with primary brEast caNcer compared with healthy conTrols. The ORNAMENT study|
|- hypothesis||Circulating miRNAs can be easily measured in body fluids which, in case of nipple fluid, could offer a promising minimally invasive method to complement current breast cancer screening methods, especially for high-risk women. In this study we aim to assess the microRNA expression levels in nipple aspiration fluids of women with recently diagnosed breast cancer where we will compare the results to those obtained in healthy controls (which is already available at our department; study NL41845.041.12). The ultimate goal is to more accurately predict the onset of breast cancer. |
|- Healt Condition(s) or Problem(s) studied||Mamma carcinoma, Breast cancer, Screening, Biomarkers|
|- Inclusion criteria||- Female age ¡Ý18 years |
- Signed informed consent
- Proven invasive breast carcinoma; or suspected invasive breast cancer (BIRADS 4 or 5)
- Willing and able to comply to the study protocol
|- Exclusion criteria||- Bilateral breast reduction with nipple graft|
- Bilateral ablative breast surgery
- Pregnancy or lactation
- Active breast infection
- Disseminated breast cancer
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-jan-2017|
|- planned closingdate||1-jan-2023|
|- Target number of participants||200|
|- Interventions||In this monocenter, cross-sectional study, nipple aspiration will be performed preoperatively in women that are recently diagnosed with, or are suspected to have breast cancer.
Nipple fluid collection:
Nipple fluid will be collected by qualified and trained study UMC Utrecht personnel at the UMC Utrecht.
This will be done before surgery in patients with biopsy proven invasive breast cancer, or in BIRADS 4/5 patients by mammography before taking the core needle biopsy for histological diagnosis.
1) The subjects are given one spray (4 IE) of oxytocin in both nostrils;
2) The nipple is gently wiped with Nuprep Skin Prep Gel in order to remove keratin plugs and subsequently cleansed with ethanol (see separate attachment);
3) Nipple fluid will be obtained by means of a manual device: A suction cup (aspirator) is placed over the nipple. Repeated gentle suction by a syringe (10-20 cc) draws fluid from inside the duct to the nipple surface. Fluid droplets are collected by capillary tubes. The entire procedure is repeated at the other breast.
Three vials of blood will be drawn. This is not a mandatory part of the study and the patients will be asked for separate consent.
|- Primary outcome||To assess the microRNA expression levels in nipple aspiration fluid obtained just before primary surgery. These will be compared to the microRNA expression levels in NAF obtained from healthy controls (which is already available at our department; study NL41845.041.12).|
|- Secondary outcome||Within patients, to compare microRNA expression in nipple aspiration fluid from the cancerous breast to microRNA expression in:|
1. tumor material obtained at surgery
3. NAF from the contralateral breast
|- Timepoints||not applicable|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Drs. S.I.S. Patuleia|
|- CONTACT for SCIENTIFIC QUERIES||Drs. S.I.S. Patuleia|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|Vrienden van UMC Utrecht|
|- Brief summary||In summary, we previously showed that we can successfully obtain nipple fluid by aspiration and assess microRNA expression levels isolated from this fluid. For further validation of the clinical value of this potential novel screening method, it is crucial to determine how well microRNA expression patterns discriminate NAF derived from cancerous and healthy breasts. Therefore, we will preoperatively aspirate nipple fluid from women having just been diagnosed with or suspected of breast cancer, and compare microRNA expression patterns in nipple fluid derived from cancerous breasts, contralateral unaffected breasts, and healthy controls. In addition we will determine microRNA expression levels in the tumor and blood of the breast cancer patient. Our ultimate goal is, through monitoring of biomarkers in nipple fluid, to develop a reliable method that on one hand allows postponing or avoiding mutilating prophylactic breast surgery as much as possible (reducing morbidity) while on the other hand determining the right time to intervene, thereby preventing development of invasive breast cancer (reducing mortality).
|- Main changes (audit trail)||13-nov-2018: Multicenter study|
|- RECORD||12-dec-2016 - 16-nov-2018|