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.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Limburg
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Maastricht、Limburg、オランダ、6200 XW
- Maastro Clinic
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The primary endpoint is the incidence and severity of locoregional late toxicity at 10 years after radiotherapy.
時間枠：One assessment approximately 10 years after radiotherapy
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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].
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One assessment approximately 10 years after radiotherapy
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The secondary endpoint is 10 year survival rate and the incidence and severity of other than locoregional late toxicity.
時間枠：One assessment approximately 10 years after radiotherapy
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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.
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One assessment approximately 10 years after radiotherapy
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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In addition, we will record potential risk factors for the several outcome parameters
時間枠：one consultation by physician (assistant) ten years after radiotherapy
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The following the potential risk factors are recorded:
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one consultation by physician (assistant) ten years after radiotherapy
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協力者と研究者
捜査官
- 主任研究者：Liesbeth J Boersma, M.D., Ph.D.、Maastro Clinic, The Netherlands
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。