A cohort for evaluating breast cancer treatments and outcomes
Utrecht Cohort for Multiple Breast Cancer Intervention Studies and Long-term Evaluation - The UMBRELLA Cohort
UMC Utrecht · NCT02839863
This study is trying to see how different treatments for breast cancer affect patients' health, quality of life, and appearance over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht (other) |
| Locations | 4 sites (Almelo and 3 other locations) |
| Trial ID | NCT02839863 on ClinicalTrials.gov |
What this trial studies
The UMBRELLA Cohort aims to create a prospective cohort of breast cancer patients undergoing irradiation at UMC Utrecht to evaluate various experimental interventions and their long-term effects. Utilizing a cohort multiple Randomized Controlled Trial (cmRCT) design, this study seeks to enhance recruitment and comparability while assessing treatment toxicity, quality of life, and cosmetic outcomes. By collecting clinical data and patient-reported outcomes through questionnaires, the study will provide a robust infrastructure for future evaluations of breast cancer interventions.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 and older with breast cancer who are receiving irradiation at UMC Utrecht.
Not a fit: Patients who are unable to understand the Dutch language may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and better quality of life for breast cancer patients.
How similar studies have performed: Other studies utilizing the cmRCT design have shown promise in evaluating multiple interventions simultaneously, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Almelo and 3 other locations
- Ziekenhuisgroep Twente — Almelo, Netherlands (RECRUITING)
- Alrijne Ziekenhuis — Leiderdorp, Netherlands (RECRUITING)
- St. Antonius Ziekenhuis — Nieuwegein, Netherlands (RECRUITING)
- University Medical Center Utrecht — Utrecht, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Helena M Verkooijen, MD, PhD — UMC Utrecht
- Study coordinator: Helena M Verkooijen, MD, PhD
- Email: h.m.verkooijen@umcutrecht.nl
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer