Hodgkin LymphomaNCT01820117
Brain Integrity in Survivors of Hodgkin Lymphoma Treated With Thoracic Radiation
An observational study of Hodgkin Lymphoma, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
While thoracic radiation therapy (TRT) has been a primary component in successful treatment of a variety of childhood and adult cancers, the exposure to this treatment has been associated with significant cardiovascular and pulmonary morbidity in long-term survivors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- Neurocognitive Evaluation, Quantitative Brain Imaging and Neurologic Evaluation
- Type of treatment
- Surgery or procedure
- How many people
- 416 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2013to 20 Feb 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: SJLIFE is an institutional initiative to establish a lifetime survivor cohort to study physical and behavioral health outcomes in adult survivors of childhood cancer. This protocol includes individuals diagnosed and treated with a malignancy during childhood at SJCRH since 1962, who are now 10 or more years from diagnosis and over 18 years of age. The current study will recruit participants from the SJLIFE cohort who received thoracic radiation as part of their treatment for Hodgkin lymphoma. Potentially eligible comparison group participants will be recruited from the relative or friend population who accompany any After Completion of Therapy (ACT) or SJLIFE patient for follow-up at SJCRH.
Who may be able to join
- Current St. Jude LIFE protocol Participant, treated with thoracic radiation
- Currently ≥ 18 years of age
- ≥ 10 years from original diagnosis
- Research participant is a sibling, parent, relative or friend of a current or former St. Jude patient
- Research participant must be at least 18 years of age at the time of the scheduled evaluation
Who cannot join
- Has participated in the previous pilot study at St. Jude (HPP16)
- History of cranial or total-body radiation therapy
- History of intrathecal Methotrexate, high-dose Methotrexate or high-dose Cytarabine.
- History of head injury or diagnosis of a genetic disorder associated with neurocognitive impairment
- Pre-existing known neurocognitive impairment prior to diagnosis of Hodgkin lymphoma
- History of congenital heart disease reported in the literature to be associated with neurocognitive status as determined by the principal investigators
Show all 15Show fewer
- Currently pregnant
- Secondary central nervous system neoplasm
- History of cranial, total-body or thoracic radiation therapy
- History of intrathecal Methotrexate, high-dose Methotrexate, or high-dose Cytarabine.
- History of head injury or diagnosis of a genetic disorder associated with neurocognitive impairment
- Known neurocognitive impairment
- History of congenital heart disease reported in the literature to be associated with neurocognitive status as determined by the principal investigators
- Currently pregnant
- Central nervous system neoplasm
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: Brain Integrity in Survivors of Hodgkin Lymphoma (HL) Treated With Thoracic Radiation
While thoracic radiation therapy (TRT) has been a primary component in successful treatment of a variety of childhood and adult cancers, the exposure to this treatment has been associated with significant cardiovascular and pulmonary morbidity in long-term survivors. Within non-cancer populations, cardiovascular and pulmonary morbidity is associated with increased risk for cerebral vascular accidents (CVAs), accelerated brain atrophy and neurocognitive impairment. Patients with chronic heart disease demonstrate problems with attention, processing speed, memory, and executive functions. Chronic pulmonary disease also increases the risk of stroke, leukoencephalopathy, and neurocognitive impairment in non-cancer populations. The investigators propose to examine indices of brain integrity, including neurocognitive performance and brain MRI/MRA, in long-term adult survivors of Hodgkin lymphoma (HL) treated with thoracic radiation and no direct central nervous system therapy.
OBJECTIVES:
- To evaluate brain integrity in adult survivors of childhood HL treated with thoracic radiation therapy.
- To identify therapeutic factors associated with brain integrity in adult survivors of childhood HL who are at risk for cardiac and pulmonary morbidity.
- To examine associations between cardiac, vascular and pulmonary health and brain integrity in adult survivors of childhood HL treated with thoracic radiation.
Read the detailed description
This is an observational study to collect health data from long-term survivors of Hodgkin lymphoma (HL). Data will be collected once at participant enrollment. The long-term effects of thoracic radiation therapy (TRT) given earlier as part of the treatment for HL will be examined in long-term survivors and compared to health data collected from normal volunteers.
HL survivors who were treated at St. Jude Children's Research Hospital (SJCRH) with TRT will be recruited to complete a comprehensive neurocognitive evaluation, brain MRI/MRA, a clinical neurological exam, peripheral pulse contour analysis, non-invasive central blood pressure monitoring, cardiopulmonary exercise testing, and serum biomarkers related to cardiac disease. As part of their standard St. Jude LIFE protocol evaluation, they also complete an echocardiogram, pulmonary function tests and questionnaires designed to evaluate broad health, psychological, socioeconomic and environmental factors that impact everyday life.
A comparison sample of healthy individuals, frequency-matched on age, sex and race will also be recruited. The comparison group will complete the comprehensive neurocognitive evaluation, brain MRI/MRA, clinical neurological exam, pulse contour analysis, non-invasive central blood pressure monitoring, and cardiopulmonary exercise testing. Through the St. Jude LIFE protocol, the comparison sample will also complete an echocardiogram, pulmonary function tests and questionnaires designed to evaluate broad health, psychological, socioeconomic and environmental factors that impact everyday life.
- Conditions
- Hodgkin Lymphoma
- Being tested
- Neurocognitive Evaluation, Quantitative Brain Imaging, Neurologic Evaluation, Health Questionnaire, Vascular Testing
- Keywords
- long-term health outcomes
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive EvaluationOther
The neurocognitive evaluation will include measures of academic achievement, intelligence, sustained attention, memory, processing speed, executive functions, functional behavior, and emotional functioning.
Quantitative Brain ImagingOther
Imaging will include raw images to both quantify white matter hyperintensities and hemosiderin deposits, as well as cortical thickness and tissue segmentation. Brain imaging will be repeated on participants who are concurrently enrolled on BRIGHT and MIND protocols at St. Jude and who completed prior brain imaging during the BRIGHT clinic visit. The repeat MRI will be done at their 6 month MIND clinic visit.
Neurologic EvaluationOther
Evaluation includes a complete review of neurologic symptoms, and interview and examination by the neurologist, assessment of neurologic symptoms and determination of their impact on day-to-day living, and quantified neurologic examination by the neurologist.
Health QuestionnaireOther
Participants will be asked to complete an approximately 450-item survey to assess health history and status, social and demographic factors, health behaviors, and psychosocial constructs.
Vascular TestingOther
Digital assessment of endothelial function will be studied, and central blood and pulse pressure and carotid-femoral pulse wave velocity will be non-invasively measured.
Cardiopulmonary Exercise TestingOther
Study participants will undergo cardiopulmonary exercise testing by treadmill. Those participants whose physical performance does not permit walking safely on the treadmill (extreme deconditioning, lower extremity paralysis, balance disorder, acute lower extremity injury) will perform cardiopulmonary exercise testing on a bicycle or upper extremity ergometer using a comparable testing protocol.
EchocardiographyOther
A complete 3D as well as 2D echocardiogram with Doppler and M-mode will be performed.
Pulmonary Function TestingOther
Pulmonary function testing will include spirometry, lung volume measurements by body plethysmography, and single-breath carbon monoxide-diffusion capacity (DLCO).
Serum BiomarkersProcedure or surgery
Blood for serum biomarkers associated with cardiovascular morbidity will be drawn, including high-sensitivity C-reactive protein, serum homocysteine.
Ophthalmology ExaminationOther
Ophthalmology examination will include a review of symptoms, examination, and fundus imaging. The examination will consist of visual acuity testing, refraction testing, retinoscopy, ocular pressure, and examination under mydriasis. Fundus photography will be used to capture an image of the retina for examination of potential hypertensive retinopathy.
| Study group | Role | What they receive |
|---|---|---|
| Hodgkin lymphoma | Participants previously treated at St. Jude Children's Research Hospital with thoracic radiation therapy for Hodgkin lymphoma.
Interventions: Neurocognitive Evaluation, Quantitative Brain Imaging, Neurologic Evaluation, Comprehensive Health Questionnaire, Vascular Testing, Cardiopulmonary Exercise Testing, Echocardiography, Pulmonary Function Testing, Serum Biomarkers, and Ophthalmology Examination. Receives: Other: Neurocognitive Evaluation; Other: Quantitative Brain Imaging; Other: Neurologic Evaluation; Other: Health Questionnaire; Other: Vascular Testing; Other: Cardiopulmonary Exercise Testing; Other: Echocardiography; Other: Pulmonary Function Testing; Procedure: Serum Biomarkers; Other: Ophthalmology Examination | |
| Normal control | A group of healthy individuals matched for age, sex and race.
Interventions: Neurocognitive Evaluation, Quantitative Brain Imaging, Neurologic Evaluation, Comprehensive Health Questionnaire, Vascular Testing, Cardiopulmonary Exercise Testing, Echocardiography, Pulmonary Function Testing, Serum Biomarkers, and Ophthalmology Examination. Receives: Other: Neurocognitive Evaluation; Other: Quantitative Brain Imaging; Other: Neurologic Evaluation; Other: Health Questionnaire; Other: Vascular Testing; Other: Cardiopulmonary Exercise Testing; Other: Echocardiography; Other: Pulmonary Function Testing; Procedure: Serum Biomarkers; Other: Ophthalmology Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive measures of sustained attention and memory between HL survivor group and control group.
To evaluate brain integrity in adult survivors of childhood cancer treated with thoracic radiation therapy.
Two-sided two-sample t test will be conducted to compare the difference of neurocognitive impairment in area of sustained attention and memory in the HL survivors and matched controls.
Measured: Once, at or near enrollment
Rate of leukoencephalopathy and hemosiderin deposits on quantitative MRI between HL survivor group and control group.
To evaluate brain integrity in adult survivors of childhood cancer treated with thoracic radiation therapy.
Two-sided two-sample proportional test will be used to compare the rates of leukoencephalopathy and hemosiderin deposits between in the HL survivors and matched controls.
Measured: Once, at or near enrollment
Rate of neurologic symptoms between HL survivor group and control group.
To evaluate brain integrity in adult survivors of childhood cancer treated with thoracic radiation therapy.
Two-sided two-sample proportional test will be used to compare the rates of neurologic symptoms between the HL survivors and matched controls.
Measured: Once, at or near enrollment
Secondary outcomes (2)
Association between thoracic radiation dose and sustained attention and memory scores and rate of leukoencephalopathy and hemosiderin deposits in HL survivors.
In HL survivors only, outcome variables will be: sustained attention (continuous), memory (continuous), leukoencephalopathy (dichotomous) and hemosiderin deposits (dichotomous). Independent variables are radiation dose to cardiopulmonary structures. Covariates will include chemotherapy exposures, particularly anthracycline exposure. For each continuous response variable, linear regression model will be used to see its association with these independent variables, adjusted for race/age/sex. Other possible covariates include educational attainment, employment and occupation, current physical activity, and alcohol and tobacco. For each dichotomous response variable, logistic regression model will be used to see its association with these independent variables, adjusted for race/age/sex. AIC criteria will be used to select the final model.
Measured: Once, at or near enrollment
Association between cardiac, vascular and pulmonary health and sustained attention and memory scores and rate of leukoencephalopathy and hemosiderin deposits.
In HL survivors only, outcome variables will be: sustained attention (continuous), memory (continuous), leukoencephalopathy (dichotomous) and hemosiderin deposits (dichotomous). Independent variables are cardiac, vascular and pulmonary health. For each continuous response variable, linear regression model will be used to see its association with these independent variables, adjusted for race/age/sex. Other possible covariates include educational attainment, employment and occupation, current physical activity, and alcohol and tobacco. For each dichotomous response variable, logistic regression model will be used to see its association with these independent variables, adjusted for race/age/sex. AIC criteria will be used to select the final model.
Measured: Once, at or near enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study start26 Apr 2013
- Primary completion20 Feb 2018
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Case-control
- Time perspective
- Other
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kevin Krull, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820117
- Sponsor's protocol ID
- BRIGHT
- Other IDs
- R01CA174794
- Status last verified
- Feb 2018
- First submitted
- 21 Mar 2013
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khan RB, Hanzlik E, Deokumar S, Xie L, Hudson MM, Krull KR, Sabin ND. Neurologic Morbidity in Survivors of Childhood Hodgkin Lymphoma Treated With Radiation. Pediatr Blood Cancer. 2026 Aug;73(8):e70398. doi: 10.1002/1545-5017.70398. Epub 2026 May 12.
PubMed 42116823
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Integrity in Survivors of Hodgkin Lymphoma (HL) Treated With Thoracic Radiation
- ClinicalTrials.gov ID
- NCT01820117
- Acronym / sponsor ID
- BRIGHT
- Conditions
- Hodgkin Lymphoma
- Keywords
- long-term health outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Apr 2013 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 28 Mar 2013 (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.
While thoracic radiation therapy (TRT) has been a primary component in successful treatment of a variety of childhood and adult cancers, the exposure to this treatment has been associated with significant cardiovascular and pulmonary morbidity in long-term survivors. Within non-cancer populations, cardiovascular and pulmonary morbidity is associated with increased risk for cerebral vascular accidents (CVAs), accelerated brain atrophy and neurocognitive impairment. Patients with chronic heart disease demonstrate problems with attention, processing speed, memory, and executive functions. Chronic pulmonary disease also increases the risk of stroke, leukoencephalopathy, and neurocognitive impairment in non-cancer populations. The investigators propose to examine indices of brain integrity, including neurocognitive performance and brain MRI/MRA, in long-term adult survivors of Hodgkin lymphoma (HL) treated with thoracic radiation and no direct central nervous system therapy.
OBJECTIVES:
- To evaluate brain integrity in adult survivors of childhood HL treated with thoracic radiation therapy.
- To identify therapeutic factors associated with brain integrity in adult survivors of childhood HL who are at risk for cardiac and pulmonary morbidity.
- To examine associations between cardiac, vascular and pulmonary health and brain integrity in adult survivors of childhood HL treated with thoracic radiation.
Detailed description
This is an observational study to collect health data from long-term survivors of Hodgkin lymphoma (HL). Data will be collected once at participant enrollment. The long-term effects of thoracic radiation therapy (TRT) given earlier as part of the treatment for HL will be examined in long-term survivors and compared to health data collected from normal volunteers.
HL survivors who were treated at St. Jude Children's Research Hospital (SJCRH) with TRT will be recruited to complete a comprehensive neurocognitive evaluation, brain MRI/MRA, a clinical neurological exam, peripheral pulse contour analysis, non-invasive central blood pressure monitoring, cardiopulmonary exercise testing, and serum biomarkers related to cardiac disease. As part of their standard St. Jude LIFE protocol evaluation, they also complete an echocardiogram, pulmonary function tests and questionnaires designed to evaluate broad health, psychological, socioeconomic and environmental factors that impact everyday life.
A comparison sample of healthy individuals, frequency-matched on age, sex and race will also be recruited. The comparison group will complete the comprehensive neurocognitive evaluation, brain MRI/MRA, clinical neurological exam, pulse contour analysis, non-invasive central blood pressure monitoring, and cardiopulmonary exercise testing. Through the St. Jude LIFE protocol, the comparison sample will also complete an echocardiogram, pulmonary function tests and questionnaires designed to evaluate broad health, psychological, socioeconomic and environmental factors that impact everyday life.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hodgkin lymphoma | – | Other: Neurocognitive Evaluation, Other: Quantitative Brain Imaging, Other: Neurologic Evaluation, Other: Health Questionnaire, Other: Vascular Testing, Other: Cardiopulmonary Exercise Testing, Other: Echocardiography, Other: Pulmonary Function Testing, Procedure: Serum Biomarkers, Other: Ophthalmology ExaminationParticipants previously treated at St. Jude Children's Research Hospital with thoracic radiation therapy for Hodgkin lymphoma. Interventions: Neurocognitive Evaluation, Quantitative Brain Imaging, Neurologic Evaluation, Comprehensive Health Questionnaire, Vascular Testing, Cardiopulmonary Exercise Testing, Echocardiography, Pulmonary Function Testing, Serum Biomarkers, and Ophthalmology Examination. |
| Normal control | – | Other: Neurocognitive Evaluation, Other: Quantitative Brain Imaging, Other: Neurologic Evaluation, Other: Health Questionnaire, Other: Vascular Testing, Other: Cardiopulmonary Exercise Testing, Other: Echocardiography, Other: Pulmonary Function Testing, Procedure: Serum Biomarkers, Other: Ophthalmology ExaminationA group of healthy individuals matched for age, sex and race. Interventions: Neurocognitive Evaluation, Quantitative Brain Imaging, Neurologic Evaluation, Comprehensive Health Questionnaire, Vascular Testing, Cardiopulmonary Exercise Testing, Echocardiography, Pulmonary Function Testing, Serum Biomarkers, and Ophthalmology Examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- SJLIFE is an institutional initiative to establish a lifetime survivor cohort to study physical and behavioral health outcomes in adult survivors of childhood cancer. This protocol includes individuals diagnosed and treated with a malignancy during childhood at SJCRH since 1962, who are now 10 or more years from diagnosis and over 18 years of age. The current study will recruit participants from the SJLIFE cohort who received thoracic radiation as part of their treatment for Hodgkin lymphoma. Potentially eligible comparison group participants will be recruited from the relative or friend population who accompany any After Completion of Therapy (ACT) or SJLIFE patient for follow-up at SJCRH.
Key inclusion criteria (5 listed)
- Current St. Jude LIFE protocol Participant, treated with thoracic radiation
- Currently ≥ 18 years of age
- ≥ 10 years from original diagnosis
- Research participant is a sibling, parent, relative or friend of a current or former St. Jude patient
- Research participant must be at least 18 years of age at the time of the scheduled evaluation
Key exclusion criteria (15 listed)
- Has participated in the previous pilot study at St. Jude (HPP16)
- History of cranial or total-body radiation therapy
- History of intrathecal Methotrexate, high-dose Methotrexate or high-dose Cytarabine.
- History of head injury or diagnosis of a genetic disorder associated with neurocognitive impairment
- Pre-existing known neurocognitive impairment prior to diagnosis of Hodgkin lymphoma
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 |
|---|---|---|
| Neurocognitive EvaluationThe neurocognitive evaluation will include measures of academic achievement, intelligence, sustained attention, memory, processing speed, executive functions, functional behavior, and emotional functioning. | Other | Hodgkin lymphoma, Normal control |
| Quantitative Brain ImagingImaging will include raw images to both quantify white matter hyperintensities and hemosiderin deposits, as well as cortical thickness and tissue segmentation. Brain imaging will be repeated on participants who are concurrently enrolled on BRIGHT and MIND protocols at St. Jude and who completed prior brain imaging during the BRIGHT clinic visit. The repeat MRI will be done at their 6 month MIND clinic visit. | Other | Hodgkin lymphoma, Normal control |
| Neurologic EvaluationEvaluation includes a complete review of neurologic symptoms, and interview and examination by the neurologist, assessment of neurologic symptoms and determination of their impact on day-to-day living, and quantified neurologic examination by the neurologist. | Other | Hodgkin lymphoma, Normal control |
| Health QuestionnaireParticipants will be asked to complete an approximately 450-item survey to assess health history and status, social and demographic factors, health behaviors, and psychosocial constructs. | Other | Hodgkin lymphoma, Normal control |
| Vascular TestingDigital assessment of endothelial function will be studied, and central blood and pulse pressure and carotid-femoral pulse wave velocity will be non-invasively measured. | Other | Hodgkin lymphoma, Normal control |
| Cardiopulmonary Exercise TestingStudy participants will undergo cardiopulmonary exercise testing by treadmill. Those participants whose physical performance does not permit walking safely on the treadmill (extreme deconditioning, lower extremity paralysis, balance disorder, acute lower extremity injury) will perform cardiopulmonary exercise testing on a bicycle or upper extremity ergometer using a comparable testing protocol. | Other | Hodgkin lymphoma, Normal control |
| EchocardiographyA complete 3D as well as 2D echocardiogram with Doppler and M-mode will be performed. | Other | Hodgkin lymphoma, Normal control |
| Pulmonary Function TestingPulmonary function testing will include spirometry, lung volume measurements by body plethysmography, and single-breath carbon monoxide-diffusion capacity (DLCO). | Other | Hodgkin lymphoma, Normal control |
| Serum BiomarkersBlood for serum biomarkers associated with cardiovascular morbidity will be drawn, including high-sensitivity C-reactive protein, serum homocysteine. | Procedure or surgery | Hodgkin lymphoma, Normal control |
| Ophthalmology ExaminationOphthalmology examination will include a review of symptoms, examination, and fundus imaging. The examination will consist of visual acuity testing, refraction testing, retinoscopy, ocular pressure, and examination under mydriasis. Fundus photography will be used to capture an image of the retina for examination of potential hypertensive retinopathy. | Other | Hodgkin lymphoma, Normal control |
Primary outcome
Neurocognitive measures of sustained attention and memory between HL survivor group and control group.
Time frame: Once, at or near enrollment
To evaluate brain integrity in adult survivors of childhood cancer treated with thoracic radiation therapy. Two-sided two-sample t test will be conducted to compare the difference of neurocognitive impairment in area of sustained attention and memory in the HL survivors and matched controls.
Rate of leukoencephalopathy and hemosiderin deposits on quantitative MRI between HL survivor group and control group.
Time frame: Once, at or near enrollment
To evaluate brain integrity in adult survivors of childhood cancer treated with thoracic radiation therapy. Two-sided two-sample proportional test will be used to compare the rates of leukoencephalopathy and hemosiderin deposits between in the HL survivors and matched controls.
Rate of neurologic symptoms between HL survivor group and control group.
Time frame: Once, at or near enrollment
To evaluate brain integrity in adult survivors of childhood cancer treated with thoracic radiation therapy. Two-sided two-sample proportional test will be used to compare the rates of neurologic symptoms between the HL survivors and matched controls.
2 secondary outcomes
Association between thoracic radiation dose and sustained attention and memory scores and rate of leukoencephalopathy and hemosiderin deposits in HL survivors.
Time frame: Once, at or near enrollment
Association between cardiac, vascular and pulmonary health and sustained attention and memory scores and rate of leukoencephalopathy and hemosiderin deposits.
Time frame: Once, at or near enrollment
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 Mar 2018.
- Derived from this study: PubMed 42116823Khan RB, Hanzlik E, Deokumar S, Xie L, Hudson MM, Krull KR, Sabin ND. Neurologic Morbidity in Survivors of Childhood Hodgkin Lymphoma Treated With Radiation. Pediatr Blood Cancer. 2026 Aug;73(8):e70398. doi: 10.1002/1545-5017.70398. Epub 2026 May 12.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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.
Kevin Krull, PhD principal investigator
St. Jude Children's Research Hospital
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 Lymphoma, run by St. Jude Children's Research Hospital 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 5 inclusion and 15 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 1 Mar 2018. 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.
What does the primary outcome measure?
Neurocognitive measures of sustained attention and memory between HL survivor group and control group. (time frame: Once, at or near enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01820117, which also lists 1 linked publication.
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 Mar 2018.