Long-term Effects Secondary to Cancer Therapy in ChildrenNCT00009711
Study of Lung Function in Children Who Have Undergone Bone Marrow Transplantation
An observational study of Long-term Effects Secondary to Cancer Therapy in Children and Pulmonary Complications, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Assessing the long-term effects of bone marrow transplant on lung function in patients may improve the ability to plan treatment. PURPOSE: This clinical trial studies lung function in pediatric patients who have undergone bone marrow transplant. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Long-term Effects Secondary to Cancer Therapy in Children, Pulmonary Complications
- What is being tested?
- management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1996to Aug 2005
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
DISEASE CHARACTERISTICS:
- Patients who have undergone bone marrow transplantation for hematologic malignancy at least 5 years ago
- Disease-free survivors at least 6 years of age AND
- Under 18 years of age at time of transplantation
- Received prior allogeneic, unrelated donor, syngeneic, or autologous bone marrow transplantation
- Able to perform pulmonary function tests
PATIENT CHARACTERISTICS:
Age:
- See Disease Characteristics
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- Any prior preparative regimen allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
About this study
Official title: The Impact of Pediatric Marrow Transplantation on Late Pulmonary Function
RATIONALE: Assessing the long-term effects of bone marrow transplant on lung function in patients may improve the ability to plan treatment.
PURPOSE: This clinical trial studies lung function in pediatric patients who have undergone bone marrow transplant.
Read the detailed description
OBJECTIVES:
- Determine the delayed effects of bone marrow transplantation preparative regimens on pulmonary function in children surviving at least 5 years after transplantation for hematologic malignancy.
- Determine the relationship between pulmonary function and growth rates in these patients.
- Determine the effect of growth hormone treatment on pulmonary function in these patients.
- Determine the relationship between pulmonary function and age at time of transplantation in these patients.
- Determine the incidence and severity of restrictive pulmonary disease, and whether these factors vary with increasing time after transplantation in these patients.
OUTLINE: Patients undergo respiratory history, signs and symptoms assessment, pulmonary function tests (PFT) including spirometry, lung volumes, and diffusion, oxygen saturation by pulse oximetry, and height measurement.
Patients are assessed at 5-10 years, 10-15 years, and over 15 years after bone marrow transplantation. Patients with abnormal PFTs are assessed at more frequent intervals as clinically indicated.
PROJECTED ACCRUAL: Approximately 280 patients will be accrued for this study.
- Being tested
- management of therapy complications
- Keywords
- long-term effects secondary to cancer therapy in children, pulmonary complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
management of therapy complicationsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 1996
- Primary completionAug 2004
- Study completionAug 2005
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 Fred Hutchinson Cancer CenterThe 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
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Jean E. Sanders, MD, Study chair, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00009711
- Sponsor's protocol ID
- 1097.00
- Other IDs
- FHCRC-1097.00, NCI-G00-1911, CDR0000065808
- Status last verified
- Apr 2013
- First submitted
- 2 Feb 2001
- Last updated
- 1 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pediatric Marrow Transplantation on Late Pulmonary Function
- ClinicalTrials.gov ID
- NCT00009711
- Acronym / sponsor ID
- 1097.00
- Keywords
- long-term effects secondary to cancer therapy in children, pulmonary complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 1996
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 27 Jan 2003 (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 bone marrow transplant on lung function in patients may improve the ability to plan treatment.
PURPOSE: This clinical trial studies lung function in pediatric patients who have undergone bone marrow transplant.
Detailed description
OBJECTIVES:
- Determine the delayed effects of bone marrow transplantation preparative regimens on pulmonary function in children surviving at least 5 years after transplantation for hematologic malignancy.
- Determine the relationship between pulmonary function and growth rates in these patients.
- Determine the effect of growth hormone treatment on pulmonary function in these patients.
- Determine the relationship between pulmonary function and age at time of transplantation in these patients.
- Determine the incidence and severity of restrictive pulmonary disease, and whether these factors vary with increasing time after transplantation in these patients.
OUTLINE: Patients undergo respiratory history, signs and symptoms assessment, pulmonary function tests (PFT) including spirometry, lung volumes, and diffusion, oxygen saturation by pulse oximetry, and height measurement.
Patients are assessed at 5-10 years, 10-15 years, and over 15 years after bone marrow transplantation. Patients with abnormal PFTs are assessed at more frequent intervals as clinically indicated.
PROJECTED ACCRUAL: Approximately 280 patients will be accrued for this study.
Study design
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| management of therapy complications | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 1 May 2013.
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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.
Jean E. Sanders, MD study chair
Fred Hutchinson Cancer Center
1 site 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 Pulmonary Complications, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 1 May 2013.