JOURNAL ONKOLOGIE – STUDIE
OPAL Advanced Breast Cancer Registry Platform
Rekrutierend
NCT-Nummer:
NCT03417115
Studienbeginn:
Dezember 2017
Letztes Update:
01.03.2021
Wirkstoff:
-
Indikation (Clinical Trials):
Breast Neoplasms
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
iOMEDICO AG
Collaborator:
-
Studienleiter
Study Chair
Praxis für interdisziplinäre Onkologie & Hämatologie
Kontakt
Kontakt:
Phone: +49 761 15242-0
E-Mail: info@iomedico.com» Kontaktdaten anzeigen
Kontakt:
Phone: +49 761 15242-0
E-Mail: info@iomedico.com» Kontaktdaten anzeigen
Studienlocations (1 von 1)
Multiple sites all over germany
Multiple Locations
GermanyRekrutierend» Google-Maps
Ansprechpartner:
iOMEDICO AG
Phone: +49 761 15242-0
E-Mail: info@iomedico.com» Ansprechpartner anzeigen
Multiple Locations
GermanyRekrutierend» Google-Maps
Ansprechpartner:
iOMEDICO AG
Phone: +49 761 15242-0
E-Mail: info@iomedico.com» Ansprechpartner anzeigen
Studien-Informationen
Detailed Description:OPAL is a national, observational, prospective, longitudinal, multicenter cohort study (tumor
registry platform) with the purpose to record information on the antineoplastic treatment of
advanced breast cancer in Germany. The registry will follow patients for up to five years. It
will identify common therapeutic sequences and changes in the treatment of the disease. At
inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous
treatments are collected. During the course of observation data on all systemic treatments,
radiotherapies, surgeries, and outcome are documented.
Health-realted quality of life in patients with advanced breast cancer will be evaluated for
up to five years.
Ein-/Ausschlusskriterien
Inclusion Criteria:- Female and male patients with advanced breast cancer (synchrone or metachrone
metastasized or locally advanced, inoperable)
- Patients at the start of their initial first-line systemic treatment for ABC, which
can be cytotoxic, endocrine or targeting a specific signaling pathway, what ever is
given first
- Written informed consent
- Patients participating in the PRO module: signing of informed consent form and
completion of baseline questionnaire before start of initial systemic treatment
- Patients not participating in the PRO module: within six weeks after start of systemic
first-line for ABC
- Age ≥ 18 years
- Patients participating in the PRO module: Sufficient knowledge of the German language
to fill-in the questionnaires
Exclusion Criteria:
- Patients with prior systemic therapy for ABC
- Patient who do not receive any systemic therapy for ABC
- Patients without ABC
Studien-Rationale
Primary outcome:1. Treatment reality (Time Frame - 5 years):
Course of systemic treatments and sequential treatments applied in German routine practice measured as the frequency of the various systemic treatments applied per line of therapy.
Secondary outcome:
1. Best Response (Time Frame - 5 years):
Documentation of response rates per line of treatment.
2. Progression-free survival (Time Frame - 5 years):
Documentation of progression-free survival per line of treatment.
3. Overall survival (Time Frame - 5 years):
Documentation of date of death.
4. Health-related quality of life (Patient-reported outcome) (Time Frame - 3.5 years):
EORTC QLQ-C30 core questionnaire and additional items.
Studien-Arme
- Her2 positive
Patients with Her2 positive tumors - triple negative
Patients with triple negative tumors - HR positive, Her2 negative
Patients with HR positive, Her2 negative tumors
Quelle: ClinicalTrials.gov
