Breast CancerNCT01978756
Outpatient Clinic for Late Outcome for Breast Carcinoma in MAASTRO Clinic.
An observational study of Breast Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
In order to evaluate the late outcome in patients curatively treated for breast cancer, a special outpatient clinic will be developed. There are two main purposes of the outpatient clinic. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Outpatient clinic
- How many people
- 387 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2013to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants are all patients who have been treated for breast cancer with curative intent in MAASTRO clinic in 2002-2003. They will be retrieved from the appointment -IT system. For all these patients will be checked whether they are alive using the MBA (municipal base administration).
Who may be able to join
- All patients treated for breast cancer with curative intent in MAASTRO clinic in 2002-2003 who are still alive.
- Consent to invitation letter and willing to participate.
Who cannot join
- Treatment without curative intent.
- No consent to invitation letter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outpatient Clinic to Evaluate Late Outcome in Patients Curatively Treated for Breast Carcinoma in MAASTRO Clinic.
In order to evaluate the late outcome in patients curatively treated for breast cancer, a special outpatient clinic will be developed.
There are two main purposes of the outpatient clinic. The first purpose is evaluating the results of the radiation treatment by mapping A) late toxicity and B) tumour control and survival.
Read more
The second purpose is that this outpatient clinic for late outcome will also function as a pilot for a new CAT (Computer Assisted Theragnostics, abbreviated CAT project) in which multiple late outcome variables will be recorded. In this pilot we want to investigate whether physical presence of the patient on the outpatient clinic, allowing physical examination, has any added value to the questionnaires filled in by the patient at home.
The ultimate aim of this new CAT project is to use these multicentric data to develop models for predicting both oncological outcome and late side effects. Insight in the beneficial and adverse effects of a certain treatment using these predictive models, will be required choose the optimal treatment for the individual patient using a shared decision making process.
- Conditions
- Breast Cancer
- Being tested
- Outpatient clinic
- Keywords
- Outpatient clinic, Breast cancer, Late toxicity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient clinicOther
The participants are seen at the outpatient clinic by a physician or a physician assistant. To analyse fibrosis clinical examination of the breast will be performed. To analyse shoulder function anteversion / retroversion, abduction / adduction and internal / external rotation will be measured. To analyse edema the arm circumference will be measured 15 cm above and below the medial epicondyle (both sides). Also, a photograph of the breast will be made for cosmetic analysis using standardized procedures. Finally a blood sample or saliva will be obtained, if the patient has given written informed consent to participate in the Biobank.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient clinic | All patients treated for breast cancer with curative intent in MAASTRO clinic in 2002-2003 who are still alive, who respond to our invitation letter and are willing to participate to visit the outpatient clinic. These patients will be sent a questionnaire with both basic and more detailed questions on their disease-status and on quality of life related outcome. In addition they will be asked to come to MAASTRO clinic for a more detailed evaluation of late side effects of the treatment. Patients are seen by a physician or a physician assistant at the outpatient clinic. Receives: Other: Outpatient clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the incidence and severity of locoregional late toxicity at 10 years after radiotherapy.
As primary endpoint, for each patients the STAT score will be determined, summarizing locoregional late toxicity, e.g. fibrosis, cosmetic outcome, shoulder dysfunction, lymphedema arm, pain [Barnett et al, 2012].
Measured: One assessment approximately 10 years after radiotherapy
Secondary outcomes (1)
The secondary endpoint is 10 year survival rate and the incidence and severity of other than locoregional late toxicity.
The secondary endpoint is 10 year survival rate, and late toxicity, other than locoregional late toxicity, e.g. fatigue, neuropathy, menopausal symptoms, cardiac and pulmonary symptoms, and secondary tumors. Survival will be divided in overall survival, locoregional recurrence free survival and distant metastases free survival. For each patient other toxicity at 10 year will be scored according to CTC-AE 4.
Measured: One assessment approximately 10 years after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2015
- Study completionJan 2015
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.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liesbeth J Boersma, M.D., Ph.D., Principal investigator, Maastro Clinic, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978756
- Sponsor's protocol ID
- 12-25-15/08
- Status last verified
- May 2016
- First submitted
- 2 Sep 2013
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Clinic to Evaluate Late Outcome in Patients Curatively Treated for Breast Carcinoma in MAASTRO Clinic.
- ClinicalTrials.gov ID
- NCT01978756
- Acronym / sponsor ID
- 12-25-15/08
- Conditions
- Breast Cancer
- Keywords
- Outpatient clinic, Breast cancer, Late toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 7 Nov 2013 (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.
In order to evaluate the late outcome in patients curatively treated for breast cancer, a special outpatient clinic will be developed.
There are two main purposes of the outpatient clinic. The first purpose is evaluating the results of the radiation treatment by mapping A) late toxicity and B) tumour control and survival.
The second purpose is that this outpatient clinic for late outcome will also function as a pilot for a new CAT (Computer Assisted Theragnostics, abbreviated CAT project) in which multiple late outcome variables will be recorded. In this pilot we want to investigate whether physical presence of the patient on the outpatient clinic, allowing physical examination, has any added value to the questionnaires filled in by the patient at home.
The ultimate aim of this new CAT project is to use these multicentric data to develop models for predicting both oncological outcome and late side effects. Insight in the beneficial and adverse effects of a certain treatment using these predictive models, will be required choose the optimal treatment for the individual patient using a shared decision making process.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatient clinic | – | Other: Outpatient clinicAll patients treated for breast cancer with curative intent in MAASTRO clinic in 2002-2003 who are still alive, who respond to our invitation letter and are willing to participate to visit the outpatient clinic. These patients will be sent a questionnaire with both basic and more detailed questions on their disease-status and on quality of life related outcome. In addition they will be asked to come to MAASTRO clinic for a more detailed evaluation of late side effects of the treatment. Patients are seen by a physician or a physician assistant at the outpatient clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are all patients who have been treated for breast cancer with curative intent in MAASTRO clinic in 2002-2003. They will be retrieved from the appointment -IT system. For all these patients will be checked whether they are alive using the MBA (municipal base administration).
Key inclusion criteria (2 listed)
- All patients treated for breast cancer with curative intent in MAASTRO clinic in 2002-2003 who are still alive.
- Consent to invitation letter and willing to participate.
Key exclusion criteria (2 listed)
- Treatment without curative intent.
- No consent to invitation letter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient clinicThe participants are seen at the outpatient clinic by a physician or a physician assistant. To analyse fibrosis clinical examination of the breast will be performed. To analyse shoulder function anteversion / retroversion, abduction / adduction and internal / external rotation will be measured. To analyse edema the arm circumference will be measured 15 cm above and below the medial epicondyle (both sides). Also, a photograph of the breast will be made for cosmetic analysis using standardized procedures. Finally a blood sample or saliva will be obtained, if the patient has given written informed consent to participate in the Biobank. | Other | Outpatient clinic |
Primary outcome
The primary endpoint is the incidence and severity of locoregional late toxicity at 10 years after radiotherapy.
Time frame: One assessment approximately 10 years after radiotherapy
As primary endpoint, for each patients the STAT score will be determined, summarizing locoregional late toxicity, e.g. fibrosis, cosmetic outcome, shoulder dysfunction, lymphedema arm, pain [Barnett et al, 2012].
1 secondary outcome
The secondary endpoint is 10 year survival rate and the incidence and severity of other than locoregional late toxicity.
Time frame: One assessment approximately 10 years after radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
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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. This study is not recruiting at the moment.
Liesbeth J Boersma, M.D., Ph.D. principal investigator
Maastro Clinic, The Netherlands
1 site 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 Maastricht Radiation Oncology at 1 site 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the incidence and severity of locoregional late toxicity at 10 years after radiotherapy. (time frame: One assessment approximately 10 years after radiotherapy). 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 24 May 2016.