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Recruiting NCT06421987

Cardiopulmonary Function and Cerebral Blood Flow in Hodgkin Lymphoma Survivors

Observational Hodgkin Lymphoma, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Near Infrared Spectroscopy (NIRS).
Who it may be relevant to
Registry conditions: Hodgkin Lymphoma, Adult. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

SURVIVORS Study participants are being asked to take part in this research study called HODNIRS because the participant is a survivor of Hodgkin Lymphoma (HL) treated with chest radiation and bleomycin at St. Jude Children's Research Hospital. The study is being done to help investigators understand the link between long term effects of chest radiation and bleomycin for HL and brain function in survivors. Primary Objective To evaluate dynamic changes in CBF and oxygenation during exercise with Near Infrared Spectroscopy (NIRS) in HL survivors and non-cancer controls matched for age, sex, race, and ethnicity. . Secondary Objectives To examine the degree of CO2 clearance (DLCO/ETCO2) during rest and exercise in Hodgkin Lymphoma (HL) survivors compared to non-cancer controls matched for age, sex, race, and ethnicity. CONTROLS Volunteers are being asked to take part in this research study because they are non-first degree relative or friend of someone who received treatment for a childhood cancer or similar illness at St. Jude Children's Research Hospital or are an employee/affiliate of St. Jude Children's Research Hospital and have agreed to be a St. Jude Life Cohort Study (SJLIFE) community control.

Detailed description

NIRS is a portable, non-invasive, brain imaging device that uses low levels of non-ionizing light to record variations in blood flow in the brain. The NIRS is wearable and can read blood flow to the brain during physical activity.

Interventions

  • Device Near Infrared Spectroscopy (NIRS)
    NIRS is a portable, non-invasive, brain imaging device.

Primary outcome measures

  • Near-Infrared Spectroscopy (NIRS) [Time frame: Baseline]
Secondary outcome measures (3)
  • Cardiopulmonary Exercise Testing (CPX) [Time frame: Baseline]
  • Pulmonary Function Testing [Time frame: Baseline]
  • Neurocognitive Outcomes [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

HL Survivors

  • Completed bleomycin and/or thoracic radiation therapy for HL at SJCRH.
  • <21-years old at diagnosis; currently ≥18-years of age and ≥2-years post therapy.
  • SJLIFE or ACT/SJLIFE participants
  • English language proficiency.

Community Controls

  • SJLIFE control.
  • ≥18-years of age at the time of enrollment with age sampling to broadly match the HL survivors.

Exclusion criteria

HL Survivors

  • History of cranial or total-body irradiation therapy.
  • History of intrathecal or high dose intravenous antimetabolite therapy.
  • History of head injury or diagnosis of a genetic disorder associated with cognitive impairment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-crossover

Study locations

United States · 1 center
  • St. Jude Children's Research Hospital — Memphis

Identifiers

NCT: NCT06421987 · HODNIRS · NCI-2024-03932

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗