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

Last updated: February 5, 2024
Sponsor: UMC Utrecht
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT02839863
NL52651.041.15
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 fillout questionnaires.

Exclusion

Exclusion Criteria:

  • Inability to understand the Dutch language

Study Design

Total Participants: 10000
Study Start date:
October 01, 2013
Estimated Completion Date:
October 31, 2053

Connect with a study center

  • Ziekenhuisgroep Twente

    Almelo,
    Netherlands

    Active - Recruiting

  • Alrijne Ziekenhuis

    Leiderdorp,
    Netherlands

    Active - Recruiting

  • St. Antonius Ziekenhuis

    Nieuwegein,
    Netherlands

    Active - Recruiting

  • University Medical Center Utrecht

    Utrecht, 3508GA
    Netherlands

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.