NCT00091091

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
530

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2004

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2004

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2011

Completed
Last Updated

July 16, 2018

Status Verified

February 1, 2017

Enrollment Period

6.6 years

First QC Date

September 7, 2004

Last Update Submit

July 13, 2018

Conditions

Keywords

long-term effects secondary to cancer therapy in childrenstage I childhood Hodgkin lymphomastage II childhood Hodgkin lymphomastage III childhood Hodgkin lymphomastage IV childhood Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

  • Risk for a specific adverse condition until the earliest of death, development of the adverse condition, loss to follow up, or completion of questionnaire

    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

Study Arms (1)

All patients

Self report/Medical record review/ clinical eval

Other: medical chart reviewOther: questionnaire administrationProcedure: management of therapy complications

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (15)

Lucile Packard Children's Hospital at Stanford University Medical Center

Palo Alto, California, 95798, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Hackensack University Medical Center Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-9786, United States

Location

Rhode Island Hospital Comprehensive Cancer Center

Providence, Rhode Island, 02903, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-3508, United States

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Debra L. Friedman, MD, MS

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2004

First Posted

September 8, 2004

Study Start

December 1, 2004

Primary Completion

June 27, 2011

Last Updated

July 16, 2018

Record last verified: 2017-02

Locations