Brain Integrity in Survivors of Hodgkin Lymphoma (HL) Treated With Thoracic Radiation
Data Collection
+ other Data
+ other Data
Hemic and Lymphatic Diseases+6
+ Immune System Diseases
+ Immunoproliferative Disorders
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: April 26, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.416 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria - HL participant: Current St. Jude LIFE protocol Participant, treated with thoracic radiation Currently ≥ 18 years of age ≥ 10 years from original diagnosis Exclusion Criteria - HL participant: 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 Currently pregnant Secondary central nervous system neoplasm 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 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
St. Jude Children's Research Hospital
Memphis, United StatesOpen St. Jude Children's Research Hospital in Google Maps