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Brain Integrity in Survivors of Hodgkin Lymphoma Treated With Thoracic Radiation


N/A
18 Years
N/A
Open (Enrolling)
Both
Hodgkin Lymphoma

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Trial Information

Brain Integrity in Survivors of Hodgkin Lymphoma Treated With Thoracic Radiation


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.

Inclusion Criteria


Inclusion Criteria - HL participant:

- Current St. Jude LIFE protocol Participant, treated with thoracic radiation

- <21 years old at diagnosis

- Currently ≥ 18 years of age

- ≥ 10 years from original diagnosis

Exclusion Criteria - HL participant:

- Have participated in the previous pilot study

- History of cranial or total-body radiation therapy

- History of intrathecal Methotrexate, high-dose Methotrexate or 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

- Currently pregnant

Inclusion Criteria - Normal Control:

- 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

Exclusion Criteria - Normal Control:

- History of cranial, total-body or thoracic radiation therapy

- History of intrathecal Methotrexate, high-dose Methotrexate, or Cytarabine.

- History of head injury or diagnosis of a genetic disorder associated with
neurocognitive impairment

- Known neurocognitive impairment

- History of congenital heart disease

- Currently pregnant

Type of Study:

Observational

Study Design:

Observational Model: Case Control

Outcome Measure:

Neurocognitive measures of sustained attention and memory between HL survivor group and control group.

Outcome Description:

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.

Outcome Time Frame:

Once, at or near enrollment

Safety Issue:

No

Principal Investigator

Kevin Krull, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

BRIGHT

NCT ID:

NCT01820117

Start Date:

March 2013

Completion Date:

April 2019

Related Keywords:

  • Hodgkin Lymphoma
  • long-term health outcomes
  • Hodgkin Disease
  • Lymphoma

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794