Breast Cancer Registry Platform

Breast Cancer Clinical Trial

— OPAL  

Official title:

Treatment and Outcome of Patients With Breast Cancer: Clinical Research Platform for Real World Data

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03417115
• Other study ID #: IOM-100361
• Secondary ID: Registerplattfor
• Status: Recruiting
• Start date: December 22, 2017
• Est. completion date: April 2029

Study information

• Verified date: March 2024
• Source: iOMEDICO AG
• Contact: Lisa Kruggel
• Phone: +49 761 15242-0
• Email: info[@]iomedico.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with breast cancer in Germany.

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 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-related quality of life in patients with breast cancer will be evaluated for up to five years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: April 2029
• Est. primary completion date: April 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

EBC cohort:

• Female and male patients with early breast cancer (stage I-III defined as breast cancer that has not spread beyond the breast or the axillary lymph nodes)

• Patients at the start of their initial systemic treatment for EBC, i.e. at start of neoadjuvant treatment for patients receiving neoadjuvant thera-py or at start of adjuvant treatment if no neoadjuvant therapy is given. Treatment can be cytotoxic, endocrine, or targeted substances, what-ever was given first

ABC cohort:

• Female and male patients with advanced breast cancer (stage IV defined as synchronous or metachronous diagnosis of distant metastases at inclusion)

• Patients at the start of their initial first-line systemic treatment for ABC, which can be cytotoxic, endocrine or targeting a specific signaling pathway, whatever is given first

All cohorts:

• 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 for EBC or systemic first-line treatment for ABC

• Patients not participating in the PRO module: within six weeks after start of initial systemic treatment for EBC or systemic first-line treatment for ABC

• Age = 18 years

Exclusion Criteria:

• Patients with prior systemic therapy (cytotoxic, endocrine, or targeted) for EBC or ABC

• Patients who do not receive any systemic therapy for EBC or ABC

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Germany	Multiple sites all over germany	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
iOMEDICO AG

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Thill M, Zahn MO, Welt A, Stickeler E, Nusch A, Fietz T, Rauh J, Wetzel N, Kruggel L, Janicke M, Marschner N, Harbeck N, Wockel A, Decker T; OPAL study group. Treatment and outcome in metastatic lobular breast cancer in the prospective German research platform OPAL. Breast Cancer Res Treat. 2023 Apr;198(3):545-553. doi: 10.1007/s10549-023-06882-7. Epub 2023 Feb 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment reality	Description of treatment reality (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.	5 years
Secondary	Best Response	Documentation of response rates per line of treatment.	5 years
Secondary	Progression-free survival	Documentation of progression-free survival per line of treatment.	5 years
Secondary	Overall survival	Documentation of date of death.	5 years
Secondary	Health-related quality of life (Patient-reported outcome)	EORTC QLQ-C30 core questionnaire and additional items.	3.5 years
Secondary	Disease-free survival	Documentation of disease-free survival.	5 years