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Registration and Informed Consent Study for the Childhood Cancer Research Network

2013年6月26日 更新者：Children's Oncology Group

Protocol for Registration and Consent to the Childhood Cancer Research Network - A Limited Institution Pilot

RATIONALE: Collecting informed consent from parents of children with cancer to register with the Childhood Cancer Research Network may help the study of cancer in the future.

PURPOSE: This study is collecting informed consent to register younger patients with cancer into the Childhood Cancer Research Network.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

  • Obtain informed consent from parents (and the child, when appropriate) of children diagnosed with cancer (who are under 21 years of age) to register their child's name and address with the Childhood Cancer Research Network.
  • Obtain informed consent from parents (and the child, when appropriate) of children diagnosed with cancer (who are under 21 years of age) to be contacted in the future for possible participation in non-therapeutic research studies involving the parents and/or child.
  • Facilitate the systematic registration of pediatric and adolescent patients diagnosed with cancer into the Childhood Cancer Research Network.

OUTLINE: Consent is obtained from parents (and pediatric patients, where applicable) to register the patient's and parent's names and addresses with the Childhood Cancer Research Network, provide a copy of the pathology report to the Network, and contact parents in the future for possible non-therapeutic research studies involving the parents and/or child.

Information provided will be held in strict confidence.

PROJECTED ACCRUAL: Not specified

研究类型

介入性

注册 (实际的)

2242

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大、T6G 1Z2
        • University of Alberta Hospital
    • Quebec
      • Montreal、Quebec、加拿大、H3H 1P3
        • Montreal Children's Hospital at McGill University Health Center
  • 美国
    • California
      • Long Beach、California、美国、90801
        • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
    • Connecticut
      • Farmington、Connecticut、美国、06360-2875
        • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
    • Florida
      • Fort Myers、Florida、美国、33901
        • Lee Cancer Care of Lee Memorial Health System
      • Gainesville、Florida、美国、32610-0232
        • University of Florida Shands Cancer Center
    • Hawaii
      • Honolulu、Hawaii、美国、95813
        • Cancer Research Center of Hawaii
    • Illinois
      • Park Ridge、Illinois、美国、60068-1174
        • Advocate Lutheran General Cancer Care Center
    • Michigan
      • Lansing、Michigan、美国、48910
        • Breslin Cancer Center at Ingham Regional Medical Center
    • Minnesota
      • Minneapolis、Minnesota、美国、55404
        • Children's Hospitals and Clinics of Minneapolis
    • New Hampshire
      • Lebanon、New Hampshire、美国、03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Hackensack、New Jersey、美国、07601
        • Hackensack University Medical Center Cancer Center
    • New York
      • Albany、New York、美国、12208-3419
        • Albany Medical Center Hospital
      • New York、New York、美国、10016
        • NYU Cancer Institute at New York University Medical Center
    • North Carolina
      • Asheville、North Carolina、美国、28801
        • Mission Hospitals - Memorial Campus
    • Ohio
      • Dayton、Ohio、美国、45404-1815
        • Children's Medical Center - Dayton
      • Youngstown、Ohio、美国、44501
        • Tod Children's Hospital - Forum Health
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19134-1095
        • St. Christopher's Hospital for Children
    • Tennessee
      • Knoxville、Tennessee、美国、37916
        • East Tennessee Children's Hospital
    • Texas
      • Corpus Christi、Texas、美国、78466
        • Driscoll Children's Hospital
    • Vermont
      • Burlington、Vermont、美国、05405
        • Fletcher Allen Health Care - University Health Center Campus

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 20年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Child (< 21 years of age) with newly diagnosed cancer

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Stratum 1: No Consent for personal identification
Data to be collected for this stratum include histology, primary site, treating hospital, and institutional principal investigator. Data will be coded using the North American Association for Central Cancer Registries (N.A.A.C.C.R.) data standards for cancer registries.
程序：educational intervention
实验性的：Stratum 2: Consent for personal identification - No Contact
Data will be collected for this study include:child's name, parent's name, address, telephone number, child's date of birth, race, ethnicity, histology, primary site, treating hospital, and institutional principal investigator. Data will be coded using the North American Association for Central Cancer Registries (N.A.A.C.C.R.) data standards for cancer registries. No contact for future to ask me to consider taking part in Research Network approved studies
程序：癌症预防干预
程序：educational intervention
实验性的：Stratum 3: Consent for personal identification - Contact
Data will be collected for this study include:child's name, parent's name, address, telephone number, child's date of birth, race, ethnicity, histology, primary site, treating hospital, and institutional principal investigator. Data will be coded using the North American Association for Central Cancer Registries (N.A.A.C.C.R.) data standards for cancer registries Someone from the Childhood Cancer Research Network may contact me in the future to ask me to consider taking part in Research Network approved studies
程序：癌症预防干预
程序：educational intervention

研究衡量的是什么？

主要结果指标

结果测量
Informed consent collection to register with the Childhood Cancer Research Network
Informed consent collection for possible participation in future non-therapeutic research studies
Facilitation of systematic registration into the Childhood Cancer Research Network

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Children's Oncology Group

合作者

National Cancer Institute (NCI)

调查人员

  • 学习椅：Julie A. Ross, PhD、Masonic Cancer Center, University of Minnesota

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2001年5月1日

初级完成 (实际的)

2007年1月1日

研究完成 (实际的)

2011年1月1日

研究注册日期

首次提交

2007年2月9日

首先提交符合 QC 标准的

2007年2月9日

首次发布 (估计)

2007年2月12日

研究记录更新

最后更新发布 (估计)

2013年6月27日

上次提交的符合 QC 标准的更新

2013年6月26日

最后验证

2013年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • AADM01P1
  • COG-AADM01P1 (其他标识符：Children's Oncology Group)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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