Breast CancerUMBRELLANCT02839863
Utrecht Cohort for Multiple Breast Cancer Intervention Studies and Long-term Evaluation - The UMBRELLA Cohort
An observational study of Breast Cancer, run by UMC Utrecht at 4 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 10,000 participants
- Where
- 4 sitesNetherlands
- Study dates
- Oct 2013to Oct 2053
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients undergoing radiation treatment
Who may be able to join
- 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.
Who cannot join
- Inability to understand the Dutch language
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Helena M Verkooijen, MD, PhD contact
Danny A Young-Afat, MD contact
Netherlands4 sites, 4 recruiting
- Recruiting
Ziekenhuisgroep Twente
Almelo
Danny Evers, MD PhD
Danny Evers, MD PhD
- Recruiting
Alrijne Ziekenhuis
Leiderdorp
Carmen van de Pol, MD
Carmen van de Pol, MD
- Recruiting
St. Antonius Ziekenhuis
Nieuwegein
Annemiek Doeksen, MD PhD, a.doeksen@antoniusziekenhuis.nl
Annemiek Doeksen, MD,PhD
- Recruiting
University Medical Center Utrecht
Utrecht, 3508GA
Helena M Verkooijen, MD, PhD, h.m.verkooijen@umcutrecht.nl
Danny A Young-Afat, MD, d.a.youngafat@umcutrecht.nl
About this study
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
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Quality of Life at 10 years
Assesment of Health-related quality of life in breast cancer patients undergoing radiation
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startOct 2013
- Primary completionOct 2053 (estimated)
- Study completionOct 2053 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena M Verkooijen, UMC Utrecht
- Investigators
- Helena M Verkooijen, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839863
- Sponsor's protocol ID
- NL52651.041.15
- Acronym
- UMBRELLA
- Status last verified
- Feb 2024
- First submitted
- 27 May 2016
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utrecht Cohort for Multiple Breast Cancer Intervention Studies and Long-term Evaluation - The UMBRELLA Cohort
- ClinicalTrials.gov ID
- NCT02839863
- Acronym / sponsor ID
- UMBRELLA / NL52651.041.15
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Oct 2053 (estimated)
- Study completion
- Oct 2053 (estimated)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients undergoing radiation treatment
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability to understand the Dutch language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline Quality of Life at 10 years
Time frame: 10 years
Assesment of Health-related quality of life in breast cancer patients undergoing radiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helena M Verkooijen, MD, PhD contact
Danny A Young-Afat, MD contact
Helena M Verkooijen, MD, PhD principal investigator
UMC Utrecht
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by UMC Utrecht at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helena M Verkooijen, MD, PhD (h.m.verkooijen@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Quality of Life at 10 years (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.