Long-Term Effects of Treatment in Patients Previously Treated for Childhood Hodgkin's Lymphoma
2018年7月13日 更新者：Children's Oncology Group
Health-Related Outcomes For Hodgkin's Disease Survivors
RATIONALE: Assessing the long-term effects of cancer treatment in cancer survivors may help improve the ability to plan effective treatment and follow-up care.
PURPOSE: This clinical trial is studying the long-term effects of treatment in patients who were previously treated for childhood Hodgkin's lymphoma.
研究概览
详细说明
OBJECTIVES:
- Determine the cumulative incidence and characterize the spectrum of selected adverse physiologic and psychosocial outcomes, using self-report and clinical evaluation, in patients previously treated for childhood Hodgkin's lymphoma.
- Compare the cumulative incidence and spectrum of self-reported adverse outcomes of these patients, using data collected at a comparable time period after diagnosis, with Hodgkin's lymphoma survivors from the Childhood Cancer Survivor Study (CCSS).
- Compare self-reported health-related outcomes with outcomes detected by clinical evaluation and medical record review of each group of patients.
OUTLINE: This is a cohort, cross-sectional, multicenter study.
- Contemporary group: Patients complete a self-report of long-term outcomes questionnaire and a comprehensive psychosocial questionnaire. A medical record review is then performed. Patients then undergo a comprehensive risk-based clinical evaluation with specific examinations and studies based upon the Children's Oncology Group Late Effects Screening Guidelines and the patients' specific therapeutic exposures.
- Childhood Cancer Survivor Study (CCSS) group: Patients undergo a telephone interview and have medical records reviewed to validate select self-reported long-term outcomes. Patient replies from the baseline CCSS questionnaire (which was completed at certain timepoints after diagnosis) are reviewed for targeted long-term outcomes.
PROJECTED ACCRUAL: Approximately 1,000 patients will be accrued for this study.
研究类型
观察性的
注册 (实际的)
530
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
-
-
California
-
Palo Alto、California、美国、95798
- Lucile Packard Children's Hospital at Stanford University Medical Center
-
-
Connecticut
-
New Haven、Connecticut、美国、06520-8028
- Yale Cancer Center
-
-
Illinois
-
Chicago、Illinois、美国、60637-1470
- University of Chicago Cancer Research Center
-
-
New Jersey
-
Hackensack、New Jersey、美国、07601
- Hackensack University Medical Center Cancer Center
-
-
New York
-
New York、New York、美国、10065
- Memorial Sloan-Kettering Cancer Center
-
New York、New York、美国、10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
-
Rochester、New York、美国、14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
-
-
Ohio
-
Cincinnati、Ohio、美国、45229-3039
- Cincinnati Children's Hospital Medical Center
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104-9786
- Children's Hospital of Philadelphia
-
-
Rhode Island
-
Providence、Rhode Island、美国、02903
- Rhode Island Hospital Comprehensive Cancer Center
-
-
Tennessee
-
Memphis、Tennessee、美国、38105
- St. Jude Children's Research Hospital
-
Nashville、Tennessee、美国、37232-6838
- Vanderbilt-Ingram Cancer Center
-
-
Texas
-
Dallas、Texas、美国、75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
-
-
Washington
-
Seattle、Washington、美国、98105
- Children's Hospital and Regional Medical Center - Seattle
-
-
Wisconsin
-
Green Bay、Wisconsin、美国、54307-3508
- St. Vincent Hospital Regional Cancer Center
-
-
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
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Treatment for primary Hodgkin disease at any one of the participating institutions 1987 - onward, or patients otherwise eligible and currently followed at one of the participating institutions.
描述
DISEASE CHARACTERISTICS:
Contemporary cohort
At least 5 years since diagnosis of Hodgkin's lymphoma
- Diagnosed between the years 1987-2001
- 21 and under at diagnosis
- No evidence of disease
Prior treatment on 1 of the following protocols during the years 1987-2001:
- Children's Cancer Group (CCG) CCG-5942, CCG-59704
- Pediatric Oncology Group (POG) POG-8625, POG-8725, POG-9425, POG-9426
- Pediatric Hodgkin's Consortium: VAMP, VEPA, VAMP/COP
- Institutional protocols COPP/ABV, MOPP/ABVD, ABVD
Childhood Cancer Survivor Study (CCSS) Hodgkin's lymphoma cohort
- Current enrollment in the CCSS
- Diagnosed between the years 1976-1986
- Completed baseline questionnaire at comparable timepoints (as the contemporary cohort) after diagnosis
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- 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
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
All patients
Self report/Medical record review/ clinical eval
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Risk for a specific adverse condition until the earliest of death, development of the adverse condition, loss to follow up, or completion of questionnaire
大体时间：length of study
|
The calculation of the incidence rates will be done in two ways: (a) using the self-report incidence of adverse conditions; and (b) using the incidence of adverse conditions validated by clinical evaluation.
|
length of study
|
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。
调查人员
- 首席研究员：Debra L. Friedman, MD, MS、Vanderbilt-Ingram Cancer Center
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
2004年12月1日
初级完成 (实际的)
2011年6月27日
研究完成
2022年12月7日
研究注册日期
首次提交
2004年9月7日
首先提交符合 QC 标准的
2004年9月7日
首次发布 (估计)
2004年9月8日
研究记录更新
最后更新发布 (实际的)
2018年7月16日
上次提交的符合 QC 标准的更新
2018年7月13日
最后验证
2017年2月1日
更多信息
与本研究相关的术语
其他研究编号
- ALTE04N1
- COG-ALTE04N1 (其他标识符：Children's Oncology Group)
- CDR0000383244 (其他标识符：Clinical Trials.gov)
- NCI-2009-00381 (注册表标识符：CTRP (Clinical Trial Reporting Program))
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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.