Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT07121920
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ex-vivo Confocal Imaging and Proteomic Profiling to Determine Treatment Response in Children With IBD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2025-08-12', 'studyFirstSubmitQcDate': '2025-08-12', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of FITC tagged antibodies', 'timeFrame': 'Baseline', 'description': 'Count of FITC tagged antibodies that maintain target specificity using fluorescence microplate reader. Used to establish baseline for fluorescent signal using FITC-tagged control antibody and control biopsy and IBD biopsy.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Ex-vivo', 'Inflammatory bowel disease', 'IBD', 'CLE', 'Confocal laser endomicroscopy'], 'conditions': ['IBD (Inflammatory Bowel Disease)', 'IBD', 'IBD - Inflammatory Bowel Disease']}, 'referencesModule': {'references': [{'pmid': '28809388', 'type': 'BACKGROUND', 'citation': "Ghione S, Sarter H, Fumery M, Armengol-Debeir L, Savoye G, Ley D, Spyckerelle C, Pariente B, Peyrin-Biroulet L, Turck D, Gower-Rousseau C, Andre JM, Antonietti M, Aouakli A, Armand A, Aroichane I, Assi F, Aubet JP, Auxenfants E, Ayafi-Ramelot F, Bankovski D, Barbry B, Bardoux N, Baron P, Baudet A, Bazin B, Bebahani A, Becqwort JP, Benet V, Benali H, Benguigui C, Soussan BE, Bental A, Berkelmans I, Bernet J, Bernou K, Bernou-Dron C, Bertot P, Bertiaux-Vandaele N, Bertrand V, Billoud E, Biron N, Bismuth B, Bleuet M, Blondel F, Blondin V, Bohon P, Boniface E, Bonniere P, Bonvarlet E, Bonvarlet P, Boruchowicz A, Bostvironnois R, Boualit M, Bouche B, Boudaillez C, Bourgeaux C, Bourgeois M, Bourguet A, Bourienne A, Branche J, Bray G, Brazier F, Breban P, Brihier H, Brung-Lefebvre V, Bulois P, Burgiere P, Butel J, Canva JY, Canva-Delcambre V, Capron JP, Cardot F, Carpentier P, Cartier E, Cassar JF, Cassagnou M, Castex JF, Catala P, Cattan S, Catteau S, Caujolle B, Cayron G, Chandelier C, Chantre M, Charles J, Charneau T, Chavance-Thelu M, Chirita D, Choteau A, Claerbout JF, Clergue PY, Coevoet H, Cohen G, Collet R, Colombel JF, Coopman S, Corvisart J, Cortot A, Couttenier F, Crinquette JF, Crombe V, Dadamessi I, Dapvril V, Davion T, Dautreme S, Debas J, Degrave N, Dehont F, Delatre C, Delcenserie R, Delette O, Delgrange T, Delhoustal L, Delmotte JS, Demmane S, Deregnaucourt G, Descombes P, Desechalliers JP, Desmet P, Desreumaux P, Desseaux G, Desurmont P, Devienne A, Devouge E, Devred M, Devroux A, Dewailly A, Dharancy S, Di Fiore A, Djeddi D, Djedir R, Dreher-Duwat ML, Dubois R, Dubuque C, Ducatillon P, Duclay J, Ducrocq B, Ducrot F, Ducrotte P, Dufilho A, Duhamel C, Dujardin D, Dumant-Forest C, Dupas JL, Dupont F, Duranton Y, Duriez A, El Achkar K, El Farisi M, Elie C, Elie-Legrand MC, Elkhaki A, Eoche M, Evrard D, Evrard JP, Fatome A, Filoche B, Finet L, Flahaut M, Flamme C, Foissey D, Fournier P, Foutrein-Comes MC, Foutrein P, Fremond D, Frere T, Fumery M, Gallet P, Gamblin C, Ganga-Zandzou PS, Gerard R, Geslin G, Gheyssens Y, Ghossini N, Ghrib S, Gilbert T, Gillet B, Godard D, Godard P, Godchaux JM, Godchaux R, Goegebeur G, Goria O, Gottrand F, Gower P, Grandmaison B, Groux M, Guedon C, Guillard JF, Guillem L, Guillemot F, Guimber D, Haddouche B, Hakim S, Hanon D, Hautefeuille V, Heckestweiller P, Hecquet G, Hedde JP, Hellal H, Henneresse PE, Heyman B, Heraud M, Herve S, Hochain P, Houssin-Bailly L, Houcke P, Huguenin B, Iobagiu S, Ivanovic A, Iwanicki-Caron I, Janicki E, Jarry M, Jeu J, Joly JP, Jonas C, Katherin F, Kerleveo A, Khachfe A, Kiriakos A, Kiriakos J, Klein O, Kohut M, Kornhauser R, Koutsomanis D, Laberenne JE, Laffineur G, Lagarde M, Lannoy P, Lapchin J, Lapprand M, Laude D, Leblanc R, Lecieux P, Leclerc N, Le Couteulx C, Ledent J, Lefebvre J, Lefiliatre P, Legrand C, Le Grix A, Lelong P, Leluyer B, Lenaerts C, Lepileur L, Leplat A, Lepoutre-Dujardin E, Leroi H, Leroy MY, Lesage JP, Lesage X, Lesage J, Lescanne-Darchis I, Lescut J, Lescut D, Leurent B, Levy P, Lhermie M, Lion A, Lisambert B, Loire F, Louf S, Louvet A, Luciani M, Lucidarme D, Lugand J, Macaigne O, Maetz D, Maillard D, Mancheron H, Manolache O, Marks-Brunel AB, Marti R, Martin F, Martin G, Marzloff E, Mathurin P, Mauillon J, Maunoury V, Maupas JL, Mesnard B, Metayer P, Methari L, Meurisse B, Meurisse F, Michaud L, Mirmaran X, Modaine P, Monthe A, Morel L, Mortier PE, Moulin E, Mouterde O, Mudry J, Nachury M, Khac NE, Notteghem B, Ollevier V, Ostyn A, Ouraghi A, Ouvry D, Paillot B, Panien-Claudot N, Paoletti C, Papazian A, Parent B, Pariente B, Paris JC, Patrier P, Paupart L, Pauwels B, Pauwels M, Petit R, Piat M, Piotte S, Plane C, Plouvier B, Pollet E, Pommelet P, Pop D, Pordes C, Pouchain G, Prades P, Prevost A, Prevost JC, Quesnel B, Queuniet AM, Quinton JF, Rabache A, Rabelle P, Raclot G, Ratajczyk S, Rault D, Razemon V, Reix N, Revillon M, Richez C, Robinson P, Rodriguez J, Roger J, Roux JM, Rudelli A, Saber A, Savoye G, Schlosseberg P, Segrestin M, Seguy D, Serin M, Seryer A, Sevenet F, Shekh N, Silvie J, Simon V, Spyckerelle C, Talbodec N, Techy A, Thelu JL, Thevenin A, Thiebault H, Thomas J, Thorel JM, Tielman G, Tode M, Toisin J, Tonnel J, Touchais JY, Touze Y, Tranvouez JL, Triplet C, Turck D, Uhlen S, Vaillant E, Valmage C, Vanco D, Vandamme H, Vanderbecq E, Eecken VE, Vandermolen P, Vandevenne P, Vandeville L, Vandewalle A, Vandewalle C, Vaneslander P, Vanhoove JP, Vanrenterghem A, Varlet P, Vasies I, Verbiese G, Vernier-Massouille G, Vermelle P, Verne C, Vezilier-Cocq P, Vigneron B, Vincendet M, Viot J, Voiment YM, Wacrenier A, Waeghemaecker L, Wallez JY, Wantiez M, Wartel F, Weber J, Willocquet JL, Wizla N, Wolschies E, Zalar A, Zaouri B, Zellweger A, Ziade C; Epimad Group. Dramatic Increase in Incidence of Ulcerative Colitis and Crohn's Disease (1988-2011): A Population-Based Study of French Adolescents. Am J Gastroenterol. 2018 Feb;113(2):265-272. doi: 10.1038/ajg.2017.228. Epub 2017 Aug 15."}, {'pmid': '28137597', 'type': 'BACKGROUND', 'citation': "Rath T, Bojarski C, Neurath MF, Atreya R. Molecular imaging of mucosal alpha4beta7 integrin expression with the fluorescent anti-adhesion antibody vedolizumab in Crohn's disease. Gastrointest Endosc. 2017 Aug;86(2):406-408. doi: 10.1016/j.gie.2017.01.012. Epub 2017 Jan 27. No abstract available."}, {'pmid': '36378498', 'type': 'BACKGROUND', 'citation': 'Iacucci M, Jeffery L, Acharjee A, Grisan E, Buda A, Nardone OM, Smith SCL, Labarile N, Zardo D, Ungar B, Hunter S, Mao R, Cannatelli R, Shivaji UN, Parigi TL, Reynolds GM, Gkoutos GV, Ghosh S. Computer-Aided Imaging Analysis of Probe-Based Confocal Laser Endomicroscopy With Molecular Labeling and Gene Expression Identifies Markers of Response to Biological Therapy in IBD Patients: The Endo-Omics Study. Inflamm Bowel Dis. 2023 Sep 1;29(9):1409-1420. doi: 10.1093/ibd/izac233.'}, {'pmid': '19107783', 'type': 'BACKGROUND', 'citation': "Hyams JS, Lerer T, Griffiths A, Pfefferkorn M, Kugathasan S, Evans J, Otley A, Carvalho R, Mack D, Bousvaros A, Rosh J, Mamula P, Kay M, Crandall W, Oliva-Hemker M, Keljo D, LeLeiko N, Markowitz J; Pediatric Inflammatory Bowel Disease Collaborative Research Group. Long-term outcome of maintenance infliximab therapy in children with Crohn's disease. Inflamm Bowel Dis. 2009 Jun;15(6):816-22. doi: 10.1002/ibd.20845."}, {'pmid': '19174781', 'type': 'BACKGROUND', 'citation': "Gisbert JP, Panes J. Loss of response and requirement of infliximab dose intensification in Crohn's disease: a review. Am J Gastroenterol. 2009 Mar;104(3):760-7. doi: 10.1038/ajg.2008.88. Epub 2009 Jan 27."}, {'pmid': '36279923', 'type': 'BACKGROUND', 'citation': 'Rath T, Atreya R, Bodenschatz J, Uter W, Geppert CE, Vitali F, Fischer S, Waldner MJ, Colombel JF, Hartmann A, Neurath MF. Intestinal Barrier Healing Is Superior to Endoscopic and Histologic Remission for Predicting Major Adverse Outcomes in Inflammatory Bowel Disease: The Prospective ERIca Trial. Gastroenterology. 2023 Feb;164(2):241-255. doi: 10.1053/j.gastro.2022.10.014. Epub 2022 Oct 21.'}, {'pmid': '24691113', 'type': 'BACKGROUND', 'citation': "Lim LG, Neumann J, Hansen T, Goetz M, Hoffman A, Neurath MF, Galle PR, Chan YH, Kiesslich R, Watson AJ. Confocal endomicroscopy identifies loss of local barrier function in the duodenum of patients with Crohn's disease and ulcerative colitis. Inflamm Bowel Dis. 2014 May;20(5):892-900. doi: 10.1097/MIB.0000000000000027."}, {'pmid': '30849396', 'type': 'BACKGROUND', 'citation': "Auzoux J, Boschetti G, Anon B, Aubourg A, Caulet M, Poisson L, Besson P, Lecomte T, Roger S, Picon L, Nancey S, Moussata D, Flourie B. Usefulness of confocal laser endomicroscopy for predicting postoperative recurrence in patients with Crohn's disease: a pilot study. Gastrointest Endosc. 2019 Jul;90(1):151-157. doi: 10.1016/j.gie.2019.02.030. Epub 2019 Mar 5."}, {'pmid': '26583952', 'type': 'BACKGROUND', 'citation': "Karstensen JG, Saftoiu A, Brynskov J, Hendel J, Klausen P, Cartana T, Klausen TW, Riis LB, Vilmann P. Confocal laser endomicroscopy: a novel method for prediction of relapse in Crohn's disease. Endoscopy. 2016 Apr;48(4):364-72. doi: 10.1055/s-0034-1393314. Epub 2015 Nov 19."}, {'pmid': '22115910', 'type': 'BACKGROUND', 'citation': 'Kiesslich R, Duckworth CA, Moussata D, Gloeckner A, Lim LG, Goetz M, Pritchard DM, Galle PR, Neurath MF, Watson AJ. Local barrier dysfunction identified by confocal laser endomicroscopy predicts relapse in inflammatory bowel disease. Gut. 2012 Aug;61(8):1146-53. doi: 10.1136/gutjnl-2011-300695. Epub 2011 Nov 24.'}, {'pmid': '26513619', 'type': 'BACKGROUND', 'citation': 'Shavrov A, Kharitonova AY, Davis EM, Claggett B, Morozov DA, Brown DK, Shavrov AA, Liu JJ. A Pilot Study of Confocal Laser Endomicroscopy to Predict Barrier Dysfunction and Relapse in Pediatric Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):873-8. doi: 10.1097/MPG.0000000000001022.'}, {'pmid': '27633594', 'type': 'BACKGROUND', 'citation': 'Buchner AM, Wallace MB. Endomicroscopy and Molecular Tools to Evaluate Inflammatory Bowel Disease. Gastrointest Endosc Clin N Am. 2016 Oct;26(4):657-68. doi: 10.1016/j.giec.2016.06.002. Epub 2016 Aug 16.'}, {'pmid': '20400099', 'type': 'BACKGROUND', 'citation': 'Abramson O, Durant M, Mow W, Finley A, Kodali P, Wong A, Tavares V, McCroskey E, Liu L, Lewis JD, Allison JE, Flowers N, Hutfless S, Velayos FS, Perry GS, Cannon R, Herrinton LJ. Incidence, prevalence, and time trends of pediatric inflammatory bowel disease in Northern California, 1996 to 2006. J Pediatr. 2010 Aug;157(2):233-239.e1. doi: 10.1016/j.jpeds.2010.02.024. Epub 2010 Apr 18.'}, {'pmid': '22926499', 'type': 'BACKGROUND', 'citation': "Kappelman MD, Moore KR, Allen JK, Cook SF. Recent trends in the prevalence of Crohn's disease and ulcerative colitis in a commercially insured US population. Dig Dis Sci. 2013 Feb;58(2):519-25. doi: 10.1007/s10620-012-2371-5. Epub 2012 Aug 29."}]}, 'descriptionModule': {'briefSummary': 'This study aims to test the overall hypothesis that the membrane tissue binding capacity of cytokines in the biopsied tissue of patients with Inflammatory Bowel Disease (IBD) is predictive of/strongly correlated to clinical response/outcomes observed.\n\nThe key questions under investigation are:\n\nAim 1: To assess the fluorescent signal intensity at baseline (control antibody with control biopsy and control antibody with IBD biopsy).\n\nAim 2: To characterize the cellular landscape by surveying surface markers using bar-coded antibodies and performing gene expression profiling on every cell within inflamed tissue of patients with IBD.\n\nAim 3: Develop algorithm using artificial intelligence to predict responders versus non-responders and to further subclassify IBD patients using phenotype data.', 'detailedDescription': 'It is estimated that approximately 5-10% of IBD patients develop the disease during childhood or adolescence. The disease onset peaks in adolescence, while 4% of children with IBD are less than 5 years of age and 18% below 10 years of age. IBD is characterized by a prolonged course of remission and relapse.\n\nIn patients with suspected IBD, endoscopy with biopsy is the gold standard method to diagnose and assess the degree and extent of inflammation. The impairment of intact intestinal epithelial barrier function is the hallmark of IBD, further involving a cascade of molecular and cellular alterations leading to delayed mucosal wound healing.\n\nIn the past decade, several studies examined the utility of probe-based confocal laser endomicroscopy (CLE) in several diseases, including IBD. The CLE is an emerging endoscopic technology developed to obtain high magnification and high-resolution images known as "optical" biopsies of the gastrointestinal mucosal histology in real-time at the cellular and sub-cellular levels.\n\nThe advantage of CLE during endoscopy is that normal tissue can be identified in real-time with high precision. A semi-quantitative test known as the Watson score was described by to describe structural and functional barrier defects in the terminal ileum in inflammatory bowel disease using CLE.\n\nAlthough the use of biologics has revolutionized the management of IBD, it is estimated that approximately 10-40% of patients with IBD on biological agents like anti-TNF such as Infliximab (IFX) are primary non-responders, with an additional 13% per patient year experiencing a secondary loss of response. In children with moderate to severe Crohn\'s disease, it was estimated that only 67% would continue maintenance infliximab after three-years and approximately 50% of pediatric patients on IFX require dose intensification during maintenance therapy.\n\nLimited studies have explored the binding of fluorescent labeled biologics ex-vivo using CLE in adults with little to no published literature in children. Studies in Europe have demonstrated that greater the binding of the biologic agent to the biopsied tissue pre-treatment, was associated with increased response to treatment, which was more pronounced in Ulcerative Colitis (AUROC 83%, PPV 89%, NPV 50%). A study abstract reported to have assessed the presence of fluorescein isothicyanate (FITC) labeled Vedolizumab (VDZ) prior to initiation of VDZ therapy in five patients with Crohn\'s Disease refractory to anti-TNF therapy. Among the 5, two of them showed α4β7 expressing mucosal cells and were found to have a good response to subsequent treatment with VDZ. However, further details of the study were not available. Similarly, a sustained improved response to anti-TNF treatment among patients with Crohn\'s Disease with high membrane-bound tumor necrosis factor (mTNF) intestinal immune cells using CLE evidenced by mucosal healing was observed on follow-up endoscopy compared to those who had low mTNF levels.\n\nWe sought to pursue the proposed study for the following reasons:\n\n1. Unlike adults, IBD is more aggressive in children, for eg. impairs physical growth, impacting quality of life, in addition to the medication toxicities on top of the limited treatment options for IBD in pediatric patients.\n2. The current approach in the management of IBD is treat to target, to achieve mucosal healing5 as subclinical inflammation could persist (as evidenced by endoscopy or histologically active disease) even though signs and symptoms have resolved. The above testing kit couples the use of CLE to determine treatment response, which aligns with the before-mentioned therapeutic goals in the management of IBD.\n3. The cost of biologics are one of the major barriers to access of this promising treatment. At Cook Children\'s Health Care System, an average of 3-4 children/adolescents are diagnosed with Crohn\'s Disease or Ulcerative Colitis per week. Physicians can judiciously use biologics depending on treatment response assessed by the proposed testing kit, which will help alleviate the overall burden of cost incurred, to both the individual as well as to the healthcare system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients must fall into one of the below categories: (i) with suspected and/or established diagnosis of IBD (ii) patients with IBD on treatment with biologics irrespective of treatment response (iii) patients who are diagnosed with IBD but treatment naïve to biologics. (iv) patients diagnosed with IBS and previous endoscopy results were negative for IBD who will serve as controls\n\nExclusion Criteria:\n\n* Those with previous allergy to fluorescein\n* Pregnant and breastfeeding patients'}, 'identificationModule': {'nctId': 'NCT07121920', 'briefTitle': 'Ex-vivo Confocal Imaging and Proteomic Profiling to Determine Treatment Response in Children With IBD', 'organization': {'class': 'OTHER', 'fullName': "Cook Children's Health Care System"}, 'officialTitle': 'A Prospective Study Evaluating Ex-vivo Confocal Imaging of Fluorescent Tagged Monoclonal Antibodies and Proteomic Profiles of Biopsied Tissue to Predict Therapeutic Response Among Children and Adolescents With Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': '2024-083'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Pediatric patients with clinical signs and symptoms suggestive of IBD or with established diagnosis of IBD (newly diagnosed or on therapeutic management) who are scheduled to undergo Esophagogastroduodenoscopy (EGD) and/or Ileocolonoscopy (IC) with CLE as part of their clinical management', 'interventionNames': ['Device: Confocal Laser Endomicroscopy']}], 'interventions': [{'name': 'Confocal Laser Endomicroscopy', 'type': 'DEVICE', 'description': 'Patients will undergo Esophagogastroduodenoscopy (EGD) and/or Ileocolonoscopy (IC) EGD with CLE as per standard of care. Each participant will have 3-4 mucosal biopsies taken from the terminal ileum, rectosigmoid and cecum, ideally from the most affected areas of accessible segment.\n\nEx vivo staining of biopsied tissue will be expanded to include FITC-labeled antibodies to cytokines IL12 and IL12/IL23 and to cytokine receptors IL12R and IL23R and possibly other cytokines, receptors and adhesion molecules. All biopsies tested for membrane bound antibodies will be done using CLE technology with artificial intelligence (AI). The cellular landscape will be characterized by surveying surface markers using bar-coded antibodies and performing gene expression profiling on every cell within inflamed tissue of patients with IBD.\n\nWe will develop algorithm using AI to predict responders versus non-responders and to further subclassify IBD patients using phenotype data.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76010', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Jon Weidanz, PhD', 'role': 'CONTACT', 'email': 'Weidanz@uta.edu', 'phone': '817-272-6831'}], 'facility': 'University of Texas at Arlington', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Sumith Roy, MBBS, MPH', 'role': 'CONTACT', 'email': 'Sumith.Roy@cookchildrens.org', 'phone': '682-885-1790'}], 'facility': "Cook Children's Health Care System", 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'centralContacts': [{'name': 'Sumith Roy, MBBS, MPH', 'role': 'CONTACT', 'email': 'Sumith.Roy@cookchildrens.org', 'phone': '682-885-1790'}, {'name': 'Chief Research Officer', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Clifton Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Cook Children's Health Care System"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Cook Children's Health Care System", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}