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

NCT02839863 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2024-02-06

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Helena M Verkooijen, MD, PhD · UMC Utrecht

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2053-10-31
Completion
2053-10-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02839863 on ClinicalTrials.gov