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NCT01820117 · ClinicalTrials.gov registry record

Brain Integrity in Survivors of Hodgkin Lymphoma Treated With Thoracic Radiation

A clinical trial, sponsored by St. Jude Children's Research Hospital.

Completed
Registry status
416
Enrollment target

NCT01820117: Completed study, sponsored by St. Jude Children's Research Hospital.

NCT01820117 is a clinical trial that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 416 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01820117 has completed, sponsored by St. Jude Children's Research Hospital.

COMPLETED
Registry status
416 participants
Enrollment target

Study 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. 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: 1. To evaluate brain integrity in adult survivors of childhood HL treated with thoracic radiation therapy. 2. To identify therapeutic factors associated with brain integrity in adult survivors of childhood HL who are at risk for cardiac and pulmonary morbidity. 3. To examine associations between cardiac, vascular and pulmonary health and brain integrity in adult survivors of childhood HL treated with thoracic radiation.

Primary Outcome

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.

Interventions

  • OTHER Neurocognitive Evaluation
  • OTHER Quantitative Brain Imaging
  • OTHER Neurologic Evaluation
  • OTHER Health Questionnaire
  • OTHER Vascular Testing

Trial Details

FieldValue
Enrollment Target 416 participants
Start Date 2013-04-26
Est. Completion 2018-02-20

What the finished NCT01820117 record still lists

NCT01820117 is an observational study that tracks outcomes without assigning an intervention. The registered 416 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 5 interventions - of which Neurocognitive Evaluation is the first listed.

NCT01820117 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01820117 about?

NCT01820117 is a clinical study titled "Brain Integrity in Survivors of Hodgkin Lymphoma 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, c...

What is the current status of trial NCT01820117?

This trial is currently completed. The enrollment target is 416 participants. The study started on 2013-04-26. Estimated completion is 2018-02-20.

What interventions are being tested in trial NCT01820117?

The interventions under investigation include: Neurocognitive Evaluation (OTHER), Quantitative Brain Imaging (OTHER), Neurologic Evaluation (OTHER), Health Questionnaire (OTHER), Vascular Testing (OTHER).

Who is sponsoring clinical trial NCT01820117?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01820117, the US trial registry maintained by the National Library of Medicine. NCT01820117 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.