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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02839863
Acronym
UMBRELLA
Enrollment
10000
Registered
2016-07-21
Start date
2013-10-31
Completion date
2053-10-31
Last updated
2024-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief 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.

Interventions

None listed

Sponsors

UMC Utrecht
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline Quality of Life at 10 years10 yearsAssesment of Health-related quality of life in breast cancer patients undergoing radiation

Countries

Netherlands

Contacts

Primary ContactHelena M Verkooijen, MD, PhD
h.m.verkooijen@umcutrecht.nl
Backup ContactDanny A Young-Afat, MD
d.a.youngafat@umcutrecht.nl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026