Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States
2018年2月5日 更新者：Bristol-Myers Squibb
This study will collect real-world data from advanced melanoma diagnosis through most recent visit and data sourced from patient medical records following a 2-part study design consisting of a random sample (Part 1) and an oversample (Part 2).
調査の概要
研究の種類
観察的
入学 (実際)
650
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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New Jersey
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Morristown、New Jersey、アメリカ、07960
- Local Institution
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Patients initiating a new line of therapy for unresectable stage III and/or metastatic (stage IV) melanoma during the index period between 01-Jan-2015 and 31-May-2016.
説明
Inclusion Criteria:
- Adults 18 years or older
- Diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma before 01-Nov-2015
- Initiating a new line of therapy during the index period between 01-Jan-2015 and 31-May-2016, irrespective of advanced melanoma diagnosis date
- Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period)
Exclusion Criteria:
- Physicians unwilling or unable to follow study instructions
- Patients who were previously enrolled in a cancer treatment-related clinical trial since the diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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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advanced melanoma patients
Part 1 will consist of a representative sample of advanced melanoma patients, irrespective of date of diagnosis of stage III unresectable and metastatic/stage IV, to address information objectives on treatment patterns, clinical outcomes, and resource use after the start of treatment post-launch of new drugs, ie, since 2011 for ipi and 2015 for ipi + nivo in advanced melanoma
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非介入
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Ipi monotherapy
Part 2: patients must have been prescribed Ipi monotherapy during the index period between 01-Jan-2015 and 31-May-2016.
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非介入
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Ipi + nivo combination therapy
Part 2: patients must have been prescribed Ipi + nivo combination therapy during the index period between 01-Jan-2015 and 31-May-2016.
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非介入
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Dabrafenib + trametinib combination therapy
Part 2: patients must have been prescribed Dabrafenib + trametinib combination therapy during the index period between 01-Jan-2015 and 31-May-2016.
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非介入
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Pembro monotherapy
Part 2: patients must have been prescribed Pembro monotherapy during the index period between 01-Jan-2015 and 31-May-2016
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非介入
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Nivo monotherapy
Part 2: patients must have been prescribed Nivo monotherapy during the index period between 01-Jan-2015 and 31-May-2016
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非介入
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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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Distribution of treatment patterns for advanced melanoma patients
時間枠：Aproximately 6 months
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Distribution of treatment patterns for advanced melanoma patients including, treatment regimen selection and rationale, as well as time to initiation of therapy and type of therapy
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Aproximately 6 months
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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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Distribution of prescribing patterns
時間枠：Approximately 16 months
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Distribution of prescribing patterns by type of practice setting and melanoma patient volume
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Approximately 16 months
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Distribution of Patient Age at index date
時間枠：at baseline
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Patient Age at index date will be determined from Medical Records
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at baseline
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Distribution of Patient's Sex at Index Date
時間枠：At Baseline
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Patient's sex will be determined from Medical Records
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At Baseline
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Distribution of Comorbidities at index date
時間枠：At Baseline
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Comorbidities will be determined using the Charlson Comorbidity Index (CCI)
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At Baseline
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Distribution of Healthcare Coverage type
時間枠：At Baseline
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Healthcare Coverage type will be determined using Medical Records
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At Baseline
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Distribution of Diagnosis Date
時間枠：At Baseline
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Melanoma Diagnosis Date will be determined using medical records
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At Baseline
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Distribution of Advanced Diagnosis Date
時間枠：At Baseline
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Date of advanced/ metastatic melanoma diagnosis will be determined using medical records
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At Baseline
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Distribution of Age at Onset
時間枠：At Baseline
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Diagnosis date-Date of Birth
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At Baseline
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Distribution of Disease stage at time of diagnosis
時間枠：At Baseline
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Disease stage at time of diagnosis will be determined using medical records
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At Baseline
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Distribution of Disease stage at subsequent visits
時間枠：Approximately 16 months
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Disease stage at subsequent visits will be determined using medical records
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Approximately 16 months
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Distribution of ECOG status at Baseline
時間枠：At Baseline
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Eastern Cooperative Oncology Group (ECOG) status at Baseline will be determined using medical records
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At Baseline
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Distribution of ECOG status at Last Visit
時間枠：Approximately 16 months
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Eastern Cooperative Oncology Group (ECOG) status at Last Visit will be determined using medical records
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Approximately 16 months
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Distribution of Biomarker status at baseline
時間枠：at baseline
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Biomarker status will be determined using Medical Records
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at baseline
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Distribution of treatment-related adverse events
時間枠：Approximately 16 months
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treatment-related adverse events will be determined using medical records
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Approximately 16 months
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Distribution of Overall Survival (OS) from Advanced Diagnosis
時間枠：Approximately 16 months
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Date of death minus advanced/metastatic diagnosis date, censoring for LTF or end of observation
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Approximately 16 months
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Distribution of Progression-Free Survival (PFS) at Advanced Diagnosis
時間枠：Approximately 16 months
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Date of progression (increase in tumor size or increase in cancer stage)/start of next line of therapy minus advanced/metastatic diagnosis date, censoring for LTF or end of observation
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Approximately 16 months
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Distribution of Overall Response Rate (ORR)
時間枠：Approximately 16 months
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Approximately 16 months
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Distribution of Overall Survival (OS) from Index Date
時間枠：Approximately 16 months
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Date of death minus index treatment start date, censoring for LTF or end of observation
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Approximately 16 months
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Distribution of Progression-Free Survival (PFS) at Index Date
時間枠：Approximately 16 months
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Date of progression (increase in tumor size or increase in cancer stage)/start of next line of therapy minus index treatment start date, censoring for LTF or end of observation
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Approximately 16 months
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Distribution of melanoma related HCRU
時間枠：Approximately 16 months
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Approximately 16 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年10月25日
一次修了 (実際)
2017年10月30日
研究の完了 (実際)
2017年12月31日
試験登録日
最初に提出
2017年6月23日
QC基準を満たした最初の提出物
2017年6月23日
最初の投稿 (実際)
2017年6月27日
学習記録の更新
投稿された最後の更新 (実際)
2018年2月6日
QC基準を満たした最後の更新が送信されました
2018年2月5日
最終確認日
2018年2月1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。
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