Predictive value of biomarkers in early breast cancer development, with a primary focus on miRNA.
Bron
Verkorte titel
Aandoening
Breast cancer, hereditary breast cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
- Predictive value of biomarkers in early breast cancer development, with a primary focus on miRNA.
- To establish biomarker profiles in NAF, follow them in time and establish a correlation with breast cancer development.
- To determine threshold values of these biomarkers that point to a significant risk of imminent breast cancer development thereby indicating the right time of prophylactic breast surgery.
Achtergrond van het onderzoek
Rationale: Breast cancer develops by the stepwise accumulation of interacting epigenetic and genetic events over time. While genetic events are specific processes that differ greatly between patients, epigenetic events are more generally occurring in breast cancer development. Therefore, epigenetic monitoring (in addition to genetic monitoring) could be a breakthrough in breast cancer prevention. Diagnostically there is a need for better procedures that will predict accurately who will and who will not develop breast cancer. MicroRNAs (miRNAs) are small, non-protein-coding RNAs (~18-25 nucleotides in length) that regulate gene expression on a post-transcriptional level by binding to and thereby suppressing specific target mRNAs. In this project we aim to assess the occurrence and changes over time of miRNA expression levels in NAF of women at high risk for breast cancer to determine risks and correct timing of interventions. The current evidence indicates that miRNAs, present in all human body fluids, have the potential to act as biomarkers of malignancy, as they show high accuracy in identifying different tumor types. With that in mind, we are in the process of establishing a Biobank of blood samples of women at increased breast cancer risk to be able to determine the usefulness of biomarkers in blood, and their correlation with results from NAF.
Objective: To establish biomarkers in NAF, follow them in time and link them to breast cancer development at its earliest stage in women at high risk for breast cancer. Threshold values of biomarkers will be determined that point to a significant risk of imminent breast cancer development, thereby indicating the right time of prophylactic breast surgery in these high-risk women.
Doel van het onderzoek
Predictive value of biomarkers in early breast cancer development, with a primary focus on miRNA.
Onderzoeksopzet
0, 6 months, 12 months, 18 months before disease onset
Onderzoeksproduct en/of interventie
A onetime dose of 4 IE oxytocin nasal spray is administered prior to the nipple fluid aspiration (NFA) procedure. Nipple fluid is obtained through the use of a manual assisted vacuum-system. After subject’s approval, three vials of blood for biobanking will be taken.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- > 20% lifetime risk of developing breast cancer (e.g. due to germline mutations such as BRCA1 or BRCA2)
- Previous DCIS/invasive breast cancer
- Female ≥ 18 years of all ethnic backgrounds
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Bilateral ablative breast surgery
- Bilateral breast reduction with nipple graft
- Pregnancy or lactation
- Active breast infection
- Disseminated breast cancer
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL8661 |
Ander register | METC UMC Utrecht : METC 06-091 (CCMO: NL11690.041.06) |