Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-01-21 @ 7:43 AM
Study NCT ID:
NCT06683092
Status:
RECRUITING
Last Update Posted:
2025-11-03
First Post:
2024-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Restarting Triple Therapy With Robust Monitoring for Adverse Events (RETRIAL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, plasma, white blood cells, stool, sputum, DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-30', 'studyFirstSubmitDate': '2024-11-08', 'studyFirstSubmitQcDate': '2024-11-08', 'lastUpdatePostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RETRIAL-Mental Health (1st objective - discontinuation): one-year incidence of discontinuation or change from VTD standard dosing due to new/worsening mental health symptoms.', 'timeFrame': 'Baseline to Month 12', 'description': 'Discontinuation or change from VTD standard dosing due to mental health symptoms at any time during the one-year follow-up as reported in either: daily diaries, biweekly or quarterly surveys, or chart review.'}, {'measure': 'RETRIAL-Mental Health (2nd objective - symptoms): proportion of participants that experience any worsening in mental health symptoms during the 6-month follow-up', 'timeFrame': 'Baseline to Month 6', 'description': 'Change from baseline that exceeds the minimally-important difference (MID) / minimally-important change (MIC) within the first 6 months after starting VTD in any of the following patient-reported outcome measures: (1) depression (PHQ-8 or PROMIS depression parent proxy), (2) anxiety (GAD-7 or PROMIS anxiety parent proxy), (3) anger and irritability (PROMIS-anger or PROMIS-anger parent proxy), (4) cognitive functioning (PROMIS- cognitive function or PROMIS-cognitive function parent proxy), (5) sleep disturbance (PROMIS-sleep disturbance or PROMIS-sleep disturbance parent proxy).'}, {'measure': "RETRIAL-Mental Health (3rd objective - RETRIAL-Neuro): proportion of participants that have a worsening on the NIH Toolbox's Fluid Cognition Composite score at 1 month follow-up.", 'timeFrame': 'Baseline to Day 30', 'description': "Decrease in age-adjusted standard score from baseline to 1 month on the NIH Toolbox's Fluid Cognition Composite Score (a performance-based neurocognitive measure) that exceeds MIC ≥ 7.5 points, signifying a worsening in function."}, {'measure': 'RETRIAL-Liver: one-year incidence of drug-induced liver injury (DILI) with VTD, defined by expert consensus after review of clinical and laboratory data.', 'timeFrame': 'Baseline to Month 12', 'description': 'Positive DILI diagnosis, including those characterized as "likely," "probable," and "highly probable," as reviewed by a hepatology panel of three experts who assign these likelihood scores based upon review of case report forms, including a specific clinical narrative and laboratory values assessing for other potential etiologies.'}], 'secondaryOutcomes': [{'measure': 'RETRIAL-Mental Health (1st objective - discontinuation): one-year incidence of discontinuation or change from VTD standard dosing due to any reason.', 'timeFrame': 'Baseline to Month 12', 'description': 'Reported discontinuation or change from VTD standard dosing due to any reason during the one-year follow-up as reported in either: daily diaries, biweekly or quarterly surveys, or chart review.'}, {'measure': 'RETRIAL-Mental Health (2nd objective - symptoms): proportion of participants that experience worsening of _each_ mental health symptom during the 6-month follow-up.', 'timeFrame': 'Baseline to Month 6', 'description': 'Change from baseline that exceeds the MID/MIC of new/worsening symptoms within the first 6 months after starting VTD for \\_each\\_ of the following patient-reported outcomes: (1) depression (PHQ-8 or PROMIS depression parent proxy), (2) anxiety (GAD-7 or PROMIS anxiety parent proxy), (3) anger and irritability (PROMIS-anger or PROMIS-anger parent proxy), (4) cognitive functioning (PROMIS- cognitive function or PROMIS-cognitive function parent proxy), (5) sleep disturbance (PROMIS-sleep disturbance or PROMIS-sleep disturbance parent proxy).'}, {'measure': "RETRIAL-Mental Health (3rd objective - RETRIAL-Neuro): proportion of participants that have a worsening of _each_ of the NIH Toolbox's cognition domain score at 1 month follow-up.", 'timeFrame': 'Baseline to Month 1', 'description': 'Decrease in age-adjusted standard score from baseline to 1-month that exceeds MIC ≥ 7.5 points for \\_each\\_ of the following domains: (1) Flanker, (2) Dimensional Change Card Sort (DCCS), (3) Picture Sequence Memory Test (PSMT), (4) List Sorting, (5) Pattern Comparison.'}, {'measure': 'RETRIAL-Liver: one-year incidence of discontinuation or change from VTD standard dosing due to patient-reported or medical team-documented concerns for liver injury.', 'timeFrame': 'Baseline to Month 12', 'description': 'Reported discontinuation or change from VTD standard dosing due to concerns for liver injury during the one-year follow-up as reported in either: 28-day or quarterly surveys, chart review, or case report forms.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['patient care', 'adverse events', 'monitoring'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'RETRIAL is a multi-site observational study of people with Cystic Fibrosis (PWCF) ages 6 and up starting the new triple-therapy modulator (vanzacaftor/tezacaftor/deutivacaftor (VTD)), after having experienced neuropsychiatric events and/or liver injury while taking elexacaftor/tezacaftor/ivacaftor (ETI) that resulted in a modification or discontinuation of standard ETI dosing.', 'detailedDescription': 'RETRIAL is a prospective, longitudinal, observational, multi-site study of people with Cystic Fibrosis (PWCF) ages 6 and up who had to either change how they took or stop taking elexacaftor/tezacaftor/ivacaftor (ETI) due to new or worsening mental health/cognitive symptoms (such as depression, anxiety, mood, sleep, and/or brain fog/memory problems) and/or liver issues (elevated liver enzymes) while taking the standard dose, and who plan to start taking vanzacaftor/tezacaftor/deutivacaftor (VTD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female and male people with CF ages 6 and older who are not able to tolerate the standard dose of ETI due to either new/worsening mental health symptoms and/or drug-induced liver injury.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nRETRIAL-Mental Health:\n\n* PWCF age 6 years and up (if age is \\< 12 years old, the PWCF\'s caregiver will complete daily diaries and surveys; see "Caregiver Participant Inclusion Criteria" below)\n* Eligible for VTD and intending to take it\n* Experienced new or worsening mental health symptoms after initiating ETI, which led to one of the following changes in treatment to currently taking:\n\n 1. No modulators\n 2. A modulator other than ETI\n 3. A flipped dose of ETI\n 4. A reduced dose of ETI\n* Willing to delay first VTD dose for short period of time to complete the Baseline assessments\n* Has access to a smart device (phone, tablet, etc.) capable of receiving messages with survey links\n* Is English-speaking.\n\nRETRIAL-LIVER:\n\n* A person with CF age 6 years and up\n* Eligible for VTD and intending to take it\n* Experienced drug-induced liver injury (as defined by local care team) after initiating ETI, which led to one of the following changes in treatment to currently taking:\n\n 1. no modulators; or\n 2. a modulator other than ETI; or\n 3. a reduced or altered dose of ETI;\n* Willing to delay first VTD dose for short period of time to complete the Baseline assessments\n* Has access to a smart device (phone, tablet, etc.) capable of receiving messages with survey links\n* Is English-speaking.\n\nExclusion Criteria:\n\nRETRIAL-Mental Health:\n\n* Cannot access VTD\n* Currently, or prior history of, taking VTD\n* Unable or unwilling to follow protocol\n* If \\<12 years old, having another \\<12-year-old person in the same household consented into the study\n* Is actively listed on any transplant list, or within 3 months post-transplant surgery\n* Is currently pregnant (test not required)\n* Anticipated change in CF Care Centers in the next 6 months\n* Any situation that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.\n\nRETRIAL-LIVER:\n\n* Cannot access VTD\n* Currently, or prior history of, taking VTD\n* Unable or unwilling to follow protocol\n* If \\<12 years old, having another \\<12-year-old person in the same household consented into the study\n* Any severe, decompensated liver disease (e.g. Child-Pugh, Class C)\n* Is actively listed on any transplant list, or within 3 months post-transplant surgery (any organ), or history of liver transplant\n* Is currently pregnant (test not required)\n* Anticipated change in CF Care Centers in the next 6 months\n* Any situation that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.\n\nCaregiver Participant:\n\nInclusion Criteria:\n\n* Is a primary, daily caregiver of a person with CF under the age of 12 enrolled in the study\n* Has access to smart device (phone, tablet, etc.) capable of receiving messages with survey links\n* Is able to read and complete surveys and Daily Diary in English.\n\nExclusion Criteria:\n\n\\- Any situation that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.'}, 'identificationModule': {'nctId': 'NCT06683092', 'briefTitle': 'Restarting Triple Therapy With Robust Monitoring for Adverse Events (RETRIAL)', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Restarting Triple Therapy With Robust Monitoring for Adverse Events (RETRIAL)', 'orgStudyIdInfo': {'id': 'IRB-P00050262'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RETRIAL-Mental Health', 'description': 'People with CF ages 6 and up with a history of new or worsening mental health symptoms (such as depression, anxiety, mood, sleep) while on elexacaftor/tezacaftor/ivacaftor (ETI) requiring discontinuation or change from standard dosing who start taking vanzacaftor/tezacaftor/deutivacaftor (VTD).', 'interventionNames': ['Other: RETRIAL-Mental Health']}, {'label': 'RETRIAL-Neuro', 'description': 'People with CF from RETRIAL-Mental Health who experienced new/worsening neurocognitive symptoms (such as brain fog or memory problems) while taking elexacaftor/tezacaftor/ivacaftor (ETI).', 'interventionNames': ['Other: RETRIAL-Neuro']}, {'label': 'RETRIAL-Liver', 'description': 'People with Cystic Fibrosis ages 6 and up with a history of drug-induced liver injury (such as elevated liver enzymes) attributed to elexacaftor/tezacaftor/ivacaftor (ETI) requiring dose modification or discontinuation who start taking vanzacaftor/tezacaftor/deutivacaftor (VTD).', 'interventionNames': ['Other: RETRIAL-Liver']}], 'interventions': [{'name': 'RETRIAL-Mental Health', 'type': 'OTHER', 'description': 'Participants will complete: daily diaries for 6 weeks, from about 2 weeks prior to starting VTD to about 4 weeks after; biweekly surveys, from about 2 weeks prior to starting VTD to 6 months after, and 2 quarterly surveys (at 9mo and 12mo post-initiation of VTD).', 'armGroupLabels': ['RETRIAL-Mental Health']}, {'name': 'RETRIAL-Liver', 'type': 'OTHER', 'description': 'Participants may have a research liver function test done prior to starting VTD and 28 days after, if not done clinically.\n\nParticipants will complete surveys: before starting VTD, a month after, and quarterly (at about 3, 6, 9, and 12 months) following VTD initiation.', 'armGroupLabels': ['RETRIAL-Liver']}, {'name': 'RETRIAL-Neuro', 'type': 'OTHER', 'description': 'Participants will complete a neurocognitive assessment prior to starting VTD and 28 days after.', 'armGroupLabels': ['RETRIAL-Neuro']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kathryn Monroe', 'role': 'CONTACT', 'email': 'kathrynmonroe@uabmc.edu'}, {'name': 'James Fowler', 'role': 'CONTACT'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Allison Keck', 'role': 'CONTACT', 'email': 'allison.keck@childrenscolorado.org'}, {'name': 'Emma Lyons, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katie Poch', 'role': 'CONTACT', 'email': 'pochk@njhealth.org'}, {'name': 'CJ Bathgate, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kimmy Renner', 'role': 'CONTACT', 'email': 'kimberly.renner@nemours.org'}, {'name': 'Kimberly Canter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Fedele, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Nemours Children's", 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Gafford', 'role': 'CONTACT', 'email': 'jennifer.gafford@nemours.org'}, {'name': 'Kimberly Canter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Fedele, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Nemours Children's", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32827', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sherry Wooldridge', 'role': 'CONTACT', 'email': 'sherry.wooldridge@nemours.org'}, {'name': 'Kimberly Canter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Fedele, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Nemours Children's", 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32514', 'city': 'Pensacola', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Davis', 'role': 'CONTACT', 'email': 'rebecca.davis@nemours.org'}, {'name': 'Kimberly Canter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Fedele, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Nemours Children's", 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashleigh Streby', 'role': 'CONTACT', 'email': 'ashleigh.streby@emory.edu'}, {'name': 'Eric Hunter', 'role': 'CONTACT'}, {'name': 'Kimberly Dickinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '47405', 'city': 'Bloomington', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lisa Bendy', 'role': 'CONTACT', 'email': 'lbendy@iu.edu'}, {'name': 'Mary Heskett', 'role': 'CONTACT'}, {'name': 'Emma Tillman, PhD PharmD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Indiana University', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megan Behrman', 'role': 'CONTACT', 'email': 'mbehrman@kumc.edu'}, {'name': 'Lawrence Scott', 'role': 'CONTACT', 'email': 'lscott2@kumc.edu'}, {'name': 'Amanda Bruce, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kansas University Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Josephine Yodzis', 'role': 'CONTACT', 'email': 'jyodzis1@jh.edu'}, {'name': 'Noah Lechtzin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ruobin Wei', 'role': 'CONTACT'}, {'name': 'Margot Hardcastle', 'role': 'CONTACT', 'email': 'mhardcastle@mgh.harvard.edu'}, {'name': 'Isabel Neuringer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sara Carvalho', 'role': 'CONTACT', 'email': 'sara.carvalho@childrens.harvard.edu'}, {'name': 'Carolyn Snell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mimi Stotsky, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dawn Kruse', 'role': 'CONTACT', 'email': 'dmkruse@med.umich.edu'}, {'name': 'Jessica Carey', 'role': 'CONTACT'}, {'name': 'Hanna Phan, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63130', 'city': 'St Louis', 'state': 'Missouri', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stacy Postma', 'role': 'CONTACT'}, {'name': 'Irma Bauer', 'role': 'CONTACT', 'email': 'irmabauer@wustl.edu'}, {'name': 'Andrea Coverston, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University at St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adrienne Dericco', 'role': 'CONTACT', 'email': 'adrienne.dericco2@upmc.edu'}, {'name': 'Traci Kazmerski, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Keianna Brown', 'role': 'CONTACT', 'email': 'Keianna.Brown@utsouthwestern.edu'}, {'name': 'David Finklea, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Meghana Sathe, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gracia Bridges', 'role': 'CONTACT', 'email': 'gracia.bridges@seattlechildrens.org'}, {'name': 'Freda Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Evelyn Bord, BS', 'role': 'CONTACT', 'email': 'evelyn.bord@childrens.harvard.edu', 'phone': '617-919-6154'}, {'name': 'Callie Bacon, MPH', 'role': 'CONTACT', 'email': 'callie.bacon@childrens.harvard.edu', 'phone': '617-919-7696'}], 'overallOfficials': [{'name': 'Anna Georgiopoulos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'CJ Bathgate, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Jewish Health'}, {'name': 'Janis Stoll, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University at St. Louis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Cystic Fibrosis Foundation', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': 'National Jewish Health', 'class': 'OTHER'}, {'name': 'Indiana University', 'class': 'OTHER'}, {'name': "Children's Hospital Colorado", 'class': 'OTHER'}, {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, {'name': 'Washington University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Chair of Success with Therapies Research Consortium', 'investigatorFullName': 'Gregory Sawicki', 'investigatorAffiliation': "Boston Children's Hospital"}}}}