Cardiopulmonary Function and Cerebral Blood Flow in Hodgkin Lymphoma Survivors

NCT06421987 | Recruiting FDA Device

• 2 other identifiers: HODNIRSNCI-2024-03932
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hodgkin Lymphoma, Adult

Outcome Measures

Primary Outcomes (1)

• Near-Infrared Spectroscopy (NIRS)

  a non-invasive imaging technology that is used to measure regional or global cerebral tissue oxygenation and cerebral blood flow (CBF) during exercise. NIRS takes advantage of the fact that oxygenated blood and de-oxygenated blood absorb light differently. By measuring the reflected light from blood, the concentration of both oxygenated hemoglobin (HbO2) and deoxygenated hemoglobin (HbdO2) using the modified Beer-Lambert Law can be calculated.

  Baseline

Secondary Outcomes (3)

• Cardiopulmonary Exercise Testing (CPX)

  Baseline

• Pulmonary Function Testing

  Baseline

• Neurocognitive Outcomes

  Baseline

Study Arms (1)

SURVIVOR

A survivor of Hodgkin Lymphoma (HL) treated with chest radiation and bleomycin at St. Jude Children's Research Hospital. and Control: Voluntarily taking part in this study because you are a relative, friend or employee of St. Jude Children's Research Hospital.

Device: Near Infrared Spectroscopy (NIRS)

Interventions

Near Infrared Spectroscopy (NIRS) DEVICE

NIRS is a portable, non-invasive, brain imaging device.

SURVIVOR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants who meet eligibility criteria and consent to enrollment on the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Nicholas Phillips, PhD

  St. Jude

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas Phillips, PhD

CONTACT

888-226-4343; referralinfo@stjude.org

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 20, 2024
• Study Start: May 6, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)