Long-term Effects Secondary to Cancer Therapy in ChildrenNCT00091091
Long-Term Effects of Treatment in Patients Previously Treated for Childhood Hodgkin's Lymphoma
An observational study of Long-term Effects Secondary to Cancer Therapy in Children and Lymphoma, run by Children's Oncology Group at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Long-term Effects Secondary to Cancer Therapy in Children, Lymphoma
- What is being tested?
- medical chart review, questionnaire administration and management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 530 participants
- Where
- 15 sitesUnited States
- Study dates
- Dec 2004to 27 Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, 07601
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Yale Cancer Center
New Haven, Connecticut, 06520-8028
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, 10032
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, 95798
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-9786
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, 02903
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- medical chart review, questionnaire administration, management of therapy complications
- Keywords
- long-term effects secondary to cancer therapy in children, stage I childhood Hodgkin lymphoma, stage II childhood Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical chart reviewOther
questionnaire administrationOther
management of therapy complicationsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| All patients | Self report/Medical record review/ clinical eval Receives: Other: medical chart review; Other: questionnaire administration; Procedure: management of therapy complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: length of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2004 (estimated)
- Study startDec 2004
- Primary completion27 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-term Effects Secondary to Cancer Therapy in ChildrenStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Debra L. Friedman, MD, MS, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091091
- Sponsor's protocol ID
- ALTE04N1
- Other IDs
- COG-ALTE04N1, CDR0000383244, NCI-2009-00381
- Status last verified
- Feb 2017
- First submitted
- 7 Sep 2004
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-Related Outcomes For Hodgkin's Disease Survivors
- ClinicalTrials.gov ID
- NCT00091091
- Acronym / sponsor ID
- ALTE04N1
- Keywords
- long-term effects secondary to cancer therapy in children, stage I childhood Hodgkin lymphoma, stage II childhood Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2004
- Primary completion
- 27 Jun 2011 (actual)
- First posted
- 8 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Other: medical chart review, Other: questionnaire administration, Procedure: management of therapy complicationsSelf report/Medical record review/ clinical eval |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical chart review | Other | All patients |
| questionnaire administration | Other | All patients |
| management of therapy complications | Procedure or surgery | All patients |
Primary outcome
Risk for a specific adverse condition until the earliest of death, development of the adverse condition, loss to follow up, or completion of questionnaire
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra L. Friedman, MD, MS principal investigator
Vanderbilt-Ingram Cancer Center
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long-term Effects Secondary to Cancer Therapy in Children and Lymphoma, run by Children's Oncology Group at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk for a specific adverse condition until the earliest of death, development of the adverse condition, loss to follow up, or completion of questionnaire (time frame: length of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018.