Hodgkin's DiseaseNCT00924131
Evaluation of Late Treatment Effects in Long-Term Survivors of Hodgkin's Disease Previously Treated at NIH: A Multi-Institutional Trial
An observational study of Hodgkin's Disease and Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Researchers are greatly interested in knowing more about the long-term effects of various treatments for cancers such as Hodgkin's disease, particularly from those who have lived 20 to 30 years after treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hodgkin's Disease, Lymphoma
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2009to 26 May 2010
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be at least 18 years of age 15
- Patients must have been previously treated for Hodgkin's Disease at the NIH
- Patient must be willing to complete quality of life questionnaires and to answer questions regarding their medical history
- Patient must be willing to provide release of medical information forms for physicians and hospitals involved in their management
- In addition to those above,
- Patient is willing to return to NIH/NIA to participate in the protocol
- Patient must have a primary physician in the community who is willing to communicate with NIH regarding clinical findings and collaborate in the clinical management and follow-up of the patient. This will be substantiated by communicating directly with the patient's physician prior to evaluation.
- Pregnant patients are eligible for follow up evaluations and quality of life evaluations. They will be excluded for any radiological testing and invasive studies. Any blood draws will be approved by the patient's obstetrician and if any of the laboratory tests to be performed have been carried out within the last three months, those values will be used instead of repeating them. Alternatively, pregnant patients may choose to participate in the study after the birth of their child to be able to participate in the full evaluation.
Who cannot join
- Inability to give informed consent
- Patients, and/ or guardians who are in the estimation of the PI, deemed unable or unlikely to adhere to protocol evaluations and follow-up requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- Researchers are greatly interested in knowing more about the long-term effects of various treatments for cancers such as Hodgkin's disease, particularly from those who have lived 20 to 30 years after treatment.
- Patients who were treated at the National Institutes of Health (NIH) may have undergone different treatments for which more long-term information is needed.
Read more
Objectives:
- To examine the body systems of long-term survivors of Hodgkin's disease to see if there are any long- term consequences of treatment for Hodgkin's disease.
- To learn more about the long-term effects of cancer treatments.
Eligibility:
- Survivors of Hodgkin's disease who were previously treated at the NIH.
- Participants must be at least 18 years of age.
Design:
- Participants will need to sign consent forms to allow researchers to obtain documentation of medical history, including prior treatment for Hodgkin's disease and prior NIH treatment, including protocol number, where applicable:
- Pertinent medical records, pathology reports, and radiographic imaging studies will be reviewed.
- Primary care physician's name, address, and other contact information are also required.
- Evaluations during the assessment period:
- Complete physical examination.
- Laboratory studies of blood, urine, and stool samples.
- Radiologic evaluations, including computerized tomography (CT) and magnetic resonance imaging (MRI) scans for all participants and mammograms for females.
- Cardiac evaluation, vascular studies, and pulmonary studies to measure heart and lung function, and digestive tests to measure stomach and intestinal function.
- Neurocognitive testing to measure brain function.
- Optional skin biopsy.
- Participants will be asked to complete questionnaires assessing current quality of life and daily living skills.
Read the detailed description
BACKGROUND:
Nearly 75% of Hodgkin's Disease (HD) patients can be cured of their disease with chemotherapy and radiotherapy, resulting in a growing number of long-term survivors.
Adverse effects of HD treatments, including second malignancies and cardiovascular disease, affect survival and quality of life. Minimizing late toxicities has become a major emphasis of current and investigational regimens.
Better characterization of long-term toxicity and quality of life (QOL) after therapy for HD and the ability to determine which late toxicities arise from a given modality may allow an ability to shape future regimens such that late toxicity can be minimized.
OBJECTIVES:
Primary objectives:
To describe the cardiac, pulmonary, and vascular function in patients previously treated for HD at NIH and to correlate this information to the treatment received.
- To measure cardiac function and abnormalities and to correlate these findings with treatment received.
- To measure pulmonary function with pulmonary function testing in survivors of HD and to correlate these findings with treatment received.
- To measure vascular function in survivors of HD and to correlate these findings with treatment received.
Secondary Objectives:
To determine if elevated plasma TGF levels correlate with the presence of late radiation fibrosis in long-term survivors of HD.
To evaluate late quality of life (QOL) in long-term survivors of HD and to correlate QOL with treatment received.
To evaluate and describe additional exploratory measures of organ function in patients previously treated for HD at NIH and to correlate this information to the treatment received.
- Heart rate variability
- Pulmonary fibrosis.
- Intestinal function.
- Neurocognitive function.
To evaluate the correlation of exploratory functional assays, biomarkers, and single nucleotide polymorphisms with the presence of late chemotherapy or radiation toxicity in long-term HD survivors.
ELIGIBILITY:
Survivors of HD previously treated at the NIH.
DESIGN:
This is a single point in time follow-up evaluation of long-term HD survivors, previously treated at the NIH.
Patients will be evaluated for late toxicities in multiple organ systems using imaging modalities, laboratory tests, functional assays, and investigational studies.
- Conditions
- Hodgkin's Disease, Lymphoma
- Keywords
- Late Effects, Radiation, Chemotherapy, Hodgkin's Disease, Lymphoma, Hodgkin Disease
- Medical subject headings
- Hodgkin Disease, Lymphoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study start17 Apr 2009
- Study completion26 May 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hodgkin's DiseaseStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Time perspective
- Other
- Enrolment
- 157 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924131
- Sponsor's protocol ID
- 090127
- Other IDs
- 09-C-0127
- Status last verified
- 26 May 2010
- First submitted
- 17 Jun 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Aisenberg AC. Problems in Hodgkin's disease management. Blood. 1999 Feb 1;93(3):761-79. No abstract available.
PubMed 9920825Fung HC, Nademanee AP. Approach to Hodgkin's lymphoma in the new millennium. Hematol Oncol. 2002 Mar;20(1):1-15. doi: 10.1002/hon.683.
PubMed 11921013AISENBERG AC. HODGKIN'S DISEASE--PROGNOSIS, TREATMENT AND ETIOLOGIC AND IMMUNOLOGIC CONSIDERATIONS. N Engl J Med. 1964 Mar 19;270:617-22 CONCL. doi: 10.1056/NEJM196403192701206. No abstract available.
PubMed 14096883
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Late Treatment Effects in Long-Term Survivors of Hodgkin's Disease Previously Treated at NIH: A Multi-Institutional Trial
- ClinicalTrials.gov ID
- NCT00924131
- Acronym / sponsor ID
- 090127
- Conditions
- Hodgkin's Disease, Lymphoma
- Keywords
- Late Effects, Radiation, Chemotherapy, Hodgkin's Disease, Lymphoma, Hodgkin Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 17 Apr 2009
- Study completion
- 26 May 2010
- First posted
- 18 Jun 2009 (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.
Background:
- Researchers are greatly interested in knowing more about the long-term effects of various treatments for cancers such as Hodgkin's disease, particularly from those who have lived 20 to 30 years after treatment.
- Patients who were treated at the National Institutes of Health (NIH) may have undergone different treatments for which more long-term information is needed.
Objectives:
- To examine the body systems of long-term survivors of Hodgkin's disease to see if there are any long- term consequences of treatment for Hodgkin's disease.
- To learn more about the long-term effects of cancer treatments.
Eligibility:
- Survivors of Hodgkin's disease who were previously treated at the NIH.
- Participants must be at least 18 years of age.
Design:
- Participants will need to sign consent forms to allow researchers to obtain documentation of medical history, including prior treatment for Hodgkin's disease and prior NIH treatment, including protocol number, where applicable:
- Pertinent medical records, pathology reports, and radiographic imaging studies will be reviewed.
- Primary care physician's name, address, and other contact information are also required.
- Evaluations during the assessment period:
- Complete physical examination.
- Laboratory studies of blood, urine, and stool samples.
- Radiologic evaluations, including computerized tomography (CT) and magnetic resonance imaging (MRI) scans for all participants and mammograms for females.
- Cardiac evaluation, vascular studies, and pulmonary studies to measure heart and lung function, and digestive tests to measure stomach and intestinal function.
- Neurocognitive testing to measure brain function.
- Optional skin biopsy.
- Participants will be asked to complete questionnaires assessing current quality of life and daily living skills.
Detailed description
BACKGROUND:
Nearly 75% of Hodgkin's Disease (HD) patients can be cured of their disease with chemotherapy and radiotherapy, resulting in a growing number of long-term survivors.
Adverse effects of HD treatments, including second malignancies and cardiovascular disease, affect survival and quality of life. Minimizing late toxicities has become a major emphasis of current and investigational regimens.
Better characterization of long-term toxicity and quality of life (QOL) after therapy for HD and the ability to determine which late toxicities arise from a given modality may allow an ability to shape future regimens such that late toxicity can be minimized.
OBJECTIVES:
Primary objectives:
To describe the cardiac, pulmonary, and vascular function in patients previously treated for HD at NIH and to correlate this information to the treatment received.
- To measure cardiac function and abnormalities and to correlate these findings with treatment received.
- To measure pulmonary function with pulmonary function testing in survivors of HD and to correlate these findings with treatment received.
- To measure vascular function in survivors of HD and to correlate these findings with treatment received.
Secondary Objectives:
To determine if elevated plasma TGF levels correlate with the presence of late radiation fibrosis in long-term survivors of HD.
To evaluate late quality of life (QOL) in long-term survivors of HD and to correlate QOL with treatment received.
To evaluate and describe additional exploratory measures of organ function in patients previously treated for HD at NIH and to correlate this information to the treatment received.
- Heart rate variability
- Pulmonary fibrosis.
- Intestinal function.
- Neurocognitive function.
To evaluate the correlation of exploratory functional assays, biomarkers, and single nucleotide polymorphisms with the presence of late chemotherapy or radiation toxicity in long-term HD survivors.
ELIGIBILITY:
Survivors of HD previously treated at the NIH.
DESIGN:
This is a single point in time follow-up evaluation of long-term HD survivors, previously treated at the NIH.
Patients will be evaluated for late toxicities in multiple organ systems using imaging modalities, laboratory tests, functional assays, and investigational studies.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must be at least 18 years of age 15
- Patients must have been previously treated for Hodgkin's Disease at the NIH
- Patient must be willing to complete quality of life questionnaires and to answer questions regarding their medical history
- Patient must be willing to provide release of medical information forms for physicians and hospitals involved in their management
- In addition to those above,
Key exclusion criteria (2 listed)
- Inability to give informed consent
- Patients, and/ or guardians who are in the estimation of the PI, deemed unable or unlikely to adhere to protocol evaluations and follow-up requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 2 Jul 2017.
- Background: PubMed 9920825Aisenberg AC. Problems in Hodgkin's disease management. Blood. 1999 Feb 1;93(3):761-79. No abstract available.
- Background: PubMed 11921013Fung HC, Nademanee AP. Approach to Hodgkin's lymphoma in the new millennium. Hematol Oncol. 2002 Mar;20(1):1-15. doi: 10.1002/hon.683.
- Background: PubMed 14096883AISENBERG AC. HODGKIN'S DISEASE--PROGNOSIS, TREATMENT AND ETIOLOGIC AND IMMUNOLOGIC CONSIDERATIONS. N Engl J Med. 1964 Mar 19;270:617-22 CONCL. doi: 10.1056/NEJM196403192701206. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hodgkin's Disease and Lymphoma, run by National Cancer Institute (NCI) 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?
The sponsor lists 8 inclusion and 2 exclusion criteria. 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 2 Jul 2017. 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?
On the ClinicalTrials.gov record for NCT00924131, which also lists 3 linked publications.
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 2 Jul 2017.