NCT02839863 Utrecht Cohort for Multiple Breast Cancer Intervention Studies and Long-term Evaluation - The UMBRELLA Cohort
| NCT ID | NCT02839863 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UMC Utrecht |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2013-10 |
| Primary Completion | 2053-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2013-10 with a primary completion date of 2053-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Helena M Verkooijen, MD, PhD
✉ h.m.verkooijen@umcutrecht.nlHelena M Verkooijen, MD, PhD
PRINCIPAL INVESTIGATOR
UMC Utrecht
Frequently Asked Questions
Who can join the NCT02839863 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02839863 currently recruiting?
Yes, NCT02839863 is actively recruiting participants. Contact the research team at h.m.verkooijen@umcutrecht.nl for enrollment information.
Where is the NCT02839863 trial being conducted?
This trial is being conducted at Almelo, Netherlands, Leiderdorp, Netherlands, Nieuwegein, Netherlands, Utrecht, Netherlands.
Who is sponsoring the NCT02839863 clinical trial?
NCT02839863 is sponsored by UMC Utrecht. The principal investigator is Helena M Verkooijen, MD, PhD at UMC Utrecht. The trial plans to enroll 10,000 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.