Studying Chromosomes in Samples From Younger Patients With Neuroblastoma
Prognostic Impact of Segmental Chromosome Aberrations in Non MYCN Amplified Neuroblastomas in Different Age Groups
調査の概要
詳細な説明
OBJECTIVES:
I. Determine the impact on overall survival of patients with non-MYCN neuroblastoma below 18 months of age as compared to neuroblastoma patients above 18 months of age.
OUTLINE:
Archived DNA samples are analyzed for segmental chromosome aberrations by multiplex ligation-dependent probe amplification (MLPA), a polymerase chain reaction (PCR)-based technique. The following genomic regions are being studied: 1p, 1q, 3p, 4p, 7q, 9p, 11q, and 17q, as are the copy numbers of MYCN, NAG, DDX1, and ALK genes.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
California
-
Monrovia、California、アメリカ、91006-3776
- Children's Oncology Group
-
-
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:
Samples from neuroblastoma patients who, according to risk stratification, did not receive cytotoxic treatment and did never receive chemotherapy and are in complete response (CR) OR patients who, according to risk stratification, did not receive cytotoxic treatment initially, but had a localized or a systemic (stage Ms or M) relapse with or without following chemotherapy
- Low-risk Children Oncology Group (COG) designation: no initial cytotoxic treatment, any stage, any age, any outcome
- DNA from untreated neuroblastoma tumor samples (from patients in the age group below and from patients in the age group above 1.5 years of age) available from the COG, Europe, Israel, and Japan
- No MYCN amplification
- No Schwann cell stroma-rich tumors
- No tumor cell content below 60%
- No DOT
- No patients diagnosed before 1997 and after 2005
- No lack of follow-up data
- See Disease Characteristics
- No initial cytotoxic treatment
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 |
|---|---|
|
Correlative studies
Archived DNA samples are analyzed (laboratory biomarker analysis) for segmental chromosome aberrations by MLPA, a PCR-based technique.
The following genomic regions are being studied: 1p, 1q, 3p, 4p, 7q, 9p, 11q, and 17q, as are the copy numbers of MYCN, NAG, DDX1, and ALK genes.
|
相関研究
|
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 |
|---|---|---|
|
Overall survival (OS)
時間枠：From the date of diagnosis to the date of death from any cause, assessed up to 5 years
|
Estimated by the Kaplan-Meier method.
|
From the date of diagnosis to the date of death from any cause, assessed up to 5 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Event-free survival (EFS)
時間枠：From the date of diagnosis to the date of disease progression, death from any cause, or secondary neoplasm, assessed up to 5 years
|
Estimated by the Kaplan-Meier method.
|
From the date of diagnosis to the date of disease progression, death from any cause, or secondary neoplasm, assessed up to 5 years
|
|
Incidence of metastatic relapses using cumulative incidences
時間枠：Up to 5 years
|
Grey's test and the model of Fine and Grey will be used for the evaluation of statistical significance.
|
Up to 5 years
|
協力者と研究者
捜査官
- 主任研究者：Peter Ambros, MD、Children's Oncology Group
研究記録日
主要日程の研究
研究開始
一次修了 (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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ANBL12B7
- NCI-2012-01961 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- CDR0000732465 (その他の識別子：Clinical Trials.gov)
- COG-ANBL12B7 (その他の識別子：Children's Oncology Group)
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。