Information sheet on the clinical trial - OPAL

Main indication

Breast cancer (mammary carcinoma)

 

Study name (study type)

OPAL (registry platform) 

Study sponsor

IOMEDICO

Registration number

ClinicalTrials.gov Identifier: NCT03417115

FOR READERS IN A HURRY:

Study for patients with breast cancer. Treatment data and questionnaires will be collected from the patients. This is an observational study and will not influence the treatment method prescribed by the physician

DETAILED INFORMATION:

This observational study is divided into

Early Breast Cancer (EBC) – Stage I–III early breast cancer

and

Advanced Breast Cancer (ABC) – inoperable or metastatic breast cancer 

The study builds on the Breast Cancer Tumor Registry launched in 2007 to depict the cross-sectoral reality of treatment for patients with early and advanced breast cancer. The purpose of the project is to establish a comprehensive database, a registry platform, for recording and documenting treatment realities and changes over time, as well as assessing effectiveness in everyday clinical practice. 

Study Title

Breast Cancer Registry Platform

Which conditions are covered by the study?

Early-stage, as well as inoperable or metastatic breast cancer 

Are specific subgroups of patients with one of the mentioned conditions being treated?

No

Background on the study medication

None

Study procedure

Patients are asked to complete a questionnaire regarding general health-related quality of life, additional symptoms, and symptom burden, as well as their employment status and ability to work. The patient survey is conducted at enrollment and then every 3 months over a total of 3.5 years. All patients are asked to provide consent for the release of routinely collected tissue samples for future research projects. 

Inclusion Criteria

• Patients with early-stage breast cancer (EBC) – Stage I–III, locally confined, not extending beyond the axillary lymph nodes,
• Patients starting their first systemic therapy
• Patients with advanced breast cancer (ABC) - metastatic or locally advanced, inoperable breast cancer
• Patients at the start of their first-line systemic treatment for advanced breast cancer (i.e., chemotherapy, hormone therapy, targeted therapy, or immunotherapy, whichever was administered first)
• Patients who are 18 years of age or older

Exclusion criteria

• Patients who have received prior systemic therapy for EBC or ABC
• No systemic therapy planned
• Participation in a study that prohibits participation in other studies

Your contacts: Investigators at the center and contact information

Dr. Andriana Haus

Email: haus@~@gp-ruesselsheim.de

Staff members responsible at the study clinic

Heike Borchert (Study Coordinator)

Email: borchert@~@gp-ruesselsheim.de

Phone: 06142 88-1032