This will be a snapshot study, this is an hypotheses-generating design, without restraining to many in- or exclusion criteria. Thereby, this design generates a population-based overview, which rapidly provides insight in current clinical practice on…
ID
Bron
Verkorte titel
Aandoening
Breast cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary outcome of this project is to create an overview of the different reasons to apply neoadjuvant systemic therapy in breast cancer patients in the Netherlands and hereby also to study the results of NST in the sense whether the upfront set goal has been reached. We furthermore hope to get insight in how often NST, in different breast cancer tumor types, results in conversion from mastectomy to BCT as well as how often NST results in axillary down staging by which ALND is omitted.
There will be two timepoints for collection data for this Snapshot registration, one at the multidisciplinary team discussion (MTD) pre-NST staging and one after the finale pathology results. Research data will be collected through our Snapshot score form and stored in Castor, an electronic database, according to Good Clinical Practice standards and will be handled confidentially and anonymously
Achtergrond van het onderzoek
The results of neoadjuvant systemic therapy (NST) in primary breast cancer patients are promising. Down staging of the tumour by NST results in an increased rate of breast conserving surgery (BCS) 1,2, and thereby less morbidity, improved cosmetic outcomes and better quality of life3,4. NST also benefits axillary down staging (ADS) with less extensive axillary surgery and its postoperative complications.
In the Netherlands criteria for NST are currently not well defined, resulting in different indications between hospitals5. This is likely to result in different treatment outcomes such as surgical treatment of the breast or axilla, differences in the amount of radiotherapy, cosmetic outcomes or quality of life.
With this study we want to investigate the next three questions considering NST in primary breast cancer patients.
1. What are the different reasons for applying NST in primary breast cancer patients in the Netherlands?
2 a. How often does NST result in conversion to BCT from a mastectomy in different tumor types?
2 b. What are the surgical outcomes (volumes, margins, re-excisions)?
3. How often does NST result in axillary down staging by which an ALND is omitted in the different tumor types?
Doel van het onderzoek
This will be a snapshot study, this is an hypotheses-generating design, without restraining to many in- or exclusion criteria. Thereby, this design generates a population-based overview, which rapidly provides insight in current clinical practice on a national scale.
Onderzoeksopzet
There will be two timepoints for collection data for this Snapshot registration, one at the multidisciplinary team discussion (MTD) pre-NST staging and one after the finale pathology results. Research data will be collected through our Snapshot score form and stored in Castor, an electronic database, according to Good Clinical Practice standards and will be handled confidentially and anonymously
Onderzoeksproduct en/of interventie
With this study we aim to provide societal and ethical justification. This is an observational research project, patients included in this research will not undergo any intervention or treatment as part of the research project. Therefore, this study is not WMO-compulsory.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Inclusion of all patients with primary breast cancer receiving NST followed by a surgical procedure as breast conserving surgery or a mastectomy.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Exclusion of patients < 18 years, not receiving surgery, receiving palliative treatment, with a history of breast cancer, benign breast tumors, pregnancy.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Data will be collected in Castor and there will be a Data Sharing Agreement.
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL8979 |
Ander register | METC VUmc : 2020.535 |