Clinical trial · Observational
Outpatient Clinic for Late Outcome for Breast Carcinoma in MAASTRO Clinic.
Outpatient Clinic to Evaluate Late Outcome in Patients Curatively Treated for Breast Carcinoma in MAASTRO Clinic.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Outpatient clinic | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Outpatient clinic
- description
- 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.
- interventionNames
- Other: Outpatient clinic
Primary outcomes (1)
- measure
- The primary endpoint is the incidence and severity of locoregional late toxicity at 10 years after radiotherapy.
- timeFrame
- One assessment approximately 10 years after radiotherapy
- description
- 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 \[Barnett et al, 2012\].
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Treatment without curative intent. * No consent to invitation letter
References
Publications (0)
Data not yet available