Utrecht Cohort for Multiple Breast Cancer Intervention Studies and Long-term Evaluation - The UMBRELLA Cohort

Breast Cancer Clinical Trial

— UMBRELLA  

Official title:

Utrecht Cohort for Multiple Breast Cancer Intervention Studies and Long-term Evaluation - The UMBRELLA Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02839863
• Other study ID #: NL52651.041.15
• Status: Recruiting
• Start date: October 2013
• Est. completion date: October 2053

Study information

• Verified date: February 2024
• Source: UMC Utrecht
• Contact: Helena M Verkooijen, MD, PhD
• Email: h.m.verkooijen[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Due to better treatment options and earlier detection, survival rates of patients with breast cancer continue to increase. As such, (late) treatment toxicity, (long-term) quality of life and the cosmetic outcome are becoming more important. Also, many competing experimental interventions (e.g. treatment, lifestyle interventions) for breast cancer are being developed, all in need to be properly evaluated before being implemented in routine clinical care. Randomized Controlled Trials are the gold standard to do so, but they have shown many challenges, especially when applied in a cancer setting. The 'cohort multiple Randomized Controlled Trial (cmRCT)' design is a promising design for multiple (simultaneous) randomized evaluations of experimental interventions, with potential for increased recruitment, comparability and long-term outcomes as a standard.

By setting up UMBRELLA, as a prospective cohort according to the cmRCT design, the investigators aim to:

• provide an infrastructure for efficient, fast and pragmatic evaluation and implementation of experimental interventions

• gain insight into short and long-term treatment response, toxicity, complications, quality of life and survival of patients with breast cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: October 2053
• Est. primary completion date: October 2053
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Patients with breast cancer who undergo irradiation in the UMC Utrecht

• Informed consent - at least - for use of routinely collected clinical data and to fill out questionnaires.

Exclusion Criteria:

• Inability to understand the Dutch language

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Netherlands	Ziekenhuisgroep Twente	Almelo
Netherlands	Alrijne Ziekenhuis	Leiderdorp
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Quality of Life at 10 years	Assesment of Health-related quality of life in breast cancer patients undergoing radiation	10 years