[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06421987":3,"trial-entities:NCT06421987":96,"trial-summary:NCT06421987":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":33,"secondary_outcomes":38,"sex":48,"minimum_age":49,"maximum_age":21,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":64,"locations":67,"central_contacts":84,"overall_officials":86,"references":89,"see_also_links":90},"NCT06421987","HODNIRS","Cardiopulmonary Function and Cerebral Blood Flow in Hodgkin Lymphoma Survivors","RECRUITING","2027-12","2026-08","2026-09-01","2024-05-06","St. Jude Children's Research Hospital","OTHER",false,"SURVIVORS\n\nStudy 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.\n\nPrimary 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. .\n\nSecondary Objectives To examine the degree of CO2 clearance (DLCO\u002FETCO2) during rest and exercise in Hodgkin Lymphoma (HL) survivors compared to non-cancer controls matched for age, sex, race, and ethnicity.\n\nCONTROLS\n\nVolunteers 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\u002Faffiliate of St. Jude Children's Research Hospital and have agreed to be a St. Jude Life Cohort Study (SJLIFE) community control.","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.",[18],"Hodgkin Lymphoma, Adult",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},100,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"DEVICE","Near Infrared Spectroscopy (NIRS)","NIRS is a portable, non-invasive, brain imaging device.",[32],"SURVIVOR",[34],{"measure":35,"description":36,"timeFrame":37},"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",[39,42,45],{"measure":40,"description":41,"timeFrame":37},"Cardiopulmonary Exercise Testing (CPX)","Cardiopulmonary Exercise Testing (CPX) will be performed with the goal of maximal exertion. Participants are monitored with 12-lead electrocardiogram (ECG) and serial blood pressure measurements during and after exercise, and during recovery. Study participants whose physical performance does not permit walking safely on the treadmill, will perform CPX on a bicycle or upper extremity ergometer using a comparable testing protocol.\n\nOxygen consumption during CPX- Oxygen will be measured at baseline and continuously during CPX. Total minute ventilation (respiratory rate X tidal volume; l\u002Fmin), and ventilatory reserve (l\u002Fmin) will be used to assess the ability of the pulmonary system to respond to exercise.",{"measure":43,"description":44,"timeFrame":37},"Pulmonary Function Testing","As part of the St. Jude Life (SJLIFE) study visit, participants will complete PFT's performed in a single laboratory according to the American Thoracic Society Task Force Guidelines. Pulmonary Function Tests (PFTs) will include:\n\n1. Forced vital capacity (FVC) - measured in liters\n2. Forced expiratory volume in 1 second (FEV1) - measured in liters\u002Fper second\n3. FEV1\u002FFVC ratio - measurement will be a percent.\n4. DLCO capacity of lung to transfer carbon monoxide - measured in mL\u002Fmin\u002Fmm Hg.\n\nThese measurements will be compared with those predicted for the participant's age, race, sex, and height.",{"measure":46,"description":47,"timeFrame":37},"Neurocognitive Outcomes","\\- As part of the SJLIFE study visit, participants will complete neurocognitive testing (Wechsler Abbreviated Scale of Intelligence; Connors Continuous Performance; California Verbal Learning; Coding Digital Symbol; Grooved Pegboard; Trail Making; Verbal Fluence; Visual Selective; Digital Span; and Rey Complex). All tests are converted to z-scores (1.0 z-score is 1 standard deviation lower than the mean).","ALL","18 Years",true,{"inclusion":52,"exclusion":59,"raw_text":63},[53,54,55,56,57,58],"Completed bleomycin and\u002For thoracic radiation therapy for HL at SJCRH.","\\\u003C21-years old at diagnosis; currently ≥18-years of age and ≥2-years post therapy.","SJLIFE or ACT\u002FSJLIFE participants","English language proficiency.","SJLIFE control.","≥18-years of age at the time of enrollment with age sampling to broadly match the HL survivors.",[60,61,62],"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.","Inclusion Criteria:\n\nHL Survivors\n\n* Completed bleomycin and\u002For thoracic radiation therapy for HL at SJCRH.\n* \\\u003C21-years old at diagnosis; currently ≥18-years of age and ≥2-years post therapy.\n* SJLIFE or ACT\u002FSJLIFE participants\n* English language proficiency.\n\nCommunity Controls\n\n* SJLIFE control.\n* ≥18-years of age at the time of enrollment with age sampling to broadly match the HL survivors.\n\nExclusion Criteria:\n\nHL Survivors\n\n* History of cranial or total-body irradiation therapy.\n* History of intrathecal or high dose intravenous antimetabolite therapy.\n* History of head injury or diagnosis of a genetic disorder associated with cognitive impairment.",[65,66],"ADULT","OLDER_ADULT",[68],{"facility":12,"status":7,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":81},"Memphis","Tennessee","38105","United States",[74,79],{"name":75,"role":76,"phone":77,"email":78},"Nicholas Phillips, PhD","CONTACT","888-226-4343","referralinfo@stjude.org",{"name":75,"role":80},"PRINCIPAL_INVESTIGATOR",{"lat":82,"lon":83},35.14953,-90.04898,[85],{"name":75,"role":76,"phone":77,"email":78},[87],{"name":75,"affiliation":88,"role":80},"St. Jude",[],[91,93],{"label":12,"url":92},"http:\u002F\u002Fwww.stjude.org",{"label":94,"url":95},"Clinical Trials Open at St. Jude","http:\u002F\u002Fwww.stjude.org\u002Fprotocols",{"nct_id":4,"conditions":97,"biomarkers":99},[98],"Hodgkin's Granuloma",[],{"nct_id":4,"found":50,"summary":101,"prompt_version":110},{"design":102,"status":103,"heading":6,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This is an observational study planning to include 100 participants, including Hodgkin Lymphoma survivors and community controls.","completed","This study, called HODNIRS, is looking at how Hodgkin Lymphoma (HL) survivors who received bleomycin and\u002For chest radiation therapy at St. Jude Children's Research Hospital are doing. Researchers want to understand if there's a connection between these past treatments and brain function. They will use a portable, non-invasive (meaning it doesn't go inside your body) device called Near-Infrared Spectroscopy (NIRS) to measure blood flow and oxygen in the brain during exercise. The study aims to compare these measurements in HL survivors to people who haven't had cancer. You might be able to join if you are an HL survivor treated at St. Jude, were under 21 at diagnosis, are now at least 18 and at least 2 years past treatment, and speak English. Community controls who are at least 18 years old can also join.","Not specified.",135,"You would have your brain blood flow and oxygen measured using a wearable NIRS device during physical activity at baseline.","Not stated in the trial record.",[],"v2"]