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.
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.
Aperçu de l'étude
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Limburg
-
Maastricht, Limburg, Pays-Bas, 6200 XW
- Maastro Clinic
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The primary endpoint is the incidence and severity of locoregional late toxicity at 10 years after radiotherapy.
Délai: 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].
|
One assessment approximately 10 years after radiotherapy
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The secondary endpoint is 10 year survival rate and the incidence and severity of other than locoregional late toxicity.
Délai: One assessment approximately 10 years after radiotherapy
|
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.
|
One assessment approximately 10 years after radiotherapy
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
In addition, we will record potential risk factors for the several outcome parameters
Délai: one consultation by physician (assistant) ten years after radiotherapy
|
The following the potential risk factors are recorded:
|
one consultation by physician (assistant) ten years after radiotherapy
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Liesbeth J Boersma, M.D., Ph.D., Maastro Clinic, The Netherlands
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 12-25-15/08
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .