Nctid:
NCT06226194
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000024821", "term"=>"Metabolic Syndrome"}, {"id"=>"D000009767", "term"=>"Obesity, Morbid"}, {"id"=>"D000001835", "term"=>"Body Weight"}, {"id"=>"D000015431", "term"=>"Weight Loss"}, {"id"=>"D000020022", "term"=>"Genetic Predisposition to Disease"}], "ancestors"=>[{"id"=>"D000001836", "term"=>"Body Weight Changes"}, {"id"=>"D000007333", "term"=>"Insulin Resistance"}, {"id"=>"D000006946", "term"=>"Hyperinsulinism"}, {"id"=>"D000044882", "term"=>"Glucose Metabolism Disorders"}, {"id"=>"D000008659", "term"=>"Metabolic Diseases"}, {"id"=>"D000004198", "term"=>"Disease Susceptibility"}, {"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000009765", "term"=>"Obesity"}, {"id"=>"D000050177", "term"=>"Overweight"}, {"id"=>"D000044343", "term"=>"Overnutrition"}, {"id"=>"D000009748", "term"=>"Nutrition Disorders"}], "browseLeaves"=>[{"id"=>"M12701", "name"=>"Obesity", "relevance"=>"LOW"}, {"id"=>"M23005", "name"=>"Metabolic Syndrome", "asFound"=>"Metabolic Syndrome", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M5114", "name"=>"Body Weight", "asFound"=>"Weight", "relevance"=>"HIGH"}, {"id"=>"M18102", "name"=>"Weight Loss", "asFound"=>"Weight Loss", "relevance"=>"HIGH"}, {"id"=>"M12702", "name"=>"Obesity, Morbid", "asFound"=>"Obesity, Morbid", "relevance"=>"HIGH"}, {"id"=>"M7380", "name"=>"Disease Susceptibility", "relevance"=>"LOW"}, {"id"=>"M21875", "name"=>"Genetic Predisposition to Disease", "asFound"=>"Genetic Susceptibility", "relevance"=>"HIGH"}, {"id"=>"M5115", "name"=>"Body Weight Changes", "relevance"=>"LOW"}, {"id"=>"M10370", "name"=>"Insulin Resistance", "relevance"=>"LOW"}, {"id"=>"M9997", "name"=>"Hyperinsulinism", "relevance"=>"LOW"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}, {"id"=>"M25403", "name"=>"Glucose Metabolism Disorders", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M26186", "name"=>"Overweight", "relevance"=>"LOW"}, {"id"=>"M25307", "name"=>"Overnutrition", "relevance"=>"LOW"}, {"id"=>"M12684", "name"=>"Nutrition Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"bioSpec"=>{"retention"=>"SAMPLES_WITH_DNA", "description"=>"Saliva and peripheral blood"}, "studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>6966}, "targetDuration"=>"3 Years", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-03-15", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-03", "completionDateStruct"=>{"date"=>"2028-11-29", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-05", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-06", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-03-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Genomic markers that can predict the weight change response to bariatric surgery", "timeFrame"=>"3 years", "description"=>"Percentage of initial weight change"}], "secondaryOutcomes"=>[{"measure"=>"Genomic markers that can predict comorbidities response to bariatric surgery", "timeFrame"=>"3 years", "description"=>"Type 2 diabetes mellitus, sleep apnea, fatty liver"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Bariatric Surgery Candidate", "Obesity, Morbid", "Genetic Predisposition", "Metabolic Syndrome", "Weight Loss"]}, "referencesModule"=>{"references"=>[{"pmid"=>"34872641", "type"=>"BACKGROUND", "citation"=>"Breton I, de Hollanda A, Vilarrasa N, Rubio Herrera MA, Lecube A, Salvador J, Garcia-Luna PP, Tinahones FJ, Sanchez Santos R, Gomez Huelgas R, Carretero Gomez J, Moize V, Polo Garcia J, Tranche Iparraguirre S, Fernandez-Pro Ledesma A, Escalada J; representing SEEN, SEEDO, SECO, SEMI, SEDYN, SEMERGEN, semFYC and SEMG. Obesity and COVID-19. A necessary position statement. Endocrinol Diabetes Nutr (Engl Ed). 2021 Oct;68(8):573-576. doi: 10.1016/j.endien.2021.02.004. Epub 2021 Nov 18. No abstract available."}, {"pmid"=>"32933882", "type"=>"BACKGROUND", "citation"=>"Ballesteros Pomar MD, Vilarrasa Garcia N, Rubio Herrera MA, Barahona MJ, Bueno M, Caixas A, Calanas Continente A, Ciudin A, Cordido F, de Hollanda A, Diaz MJ, Flores L, Garcia Luna PP, Garcia Perez-Sevillano F, Goday A, Lecube A, Lopez Gomez JJ, Minambres I, Morales Gorria MJ, Morinigo R, Nicolau J, Pellitero S, Salvador J, Valdes S, Breton Lesmes I. The SEEN comprehensive clinical survey of adult obesity: Executive summary. Endocrinol Diabetes Nutr (Engl Ed). 2021 Feb;68(2):130-136. doi: 10.1016/j.endinu.2020.05.003. Epub 2020 Sep 12. English, Spanish."}, {"pmid"=>"33398625", "type"=>"BACKGROUND", "citation"=>"Beisani M, Sabench Pereferrer F, Vilallonga R, Gonzalez Lopez O, Molina Lopez A, Del Castillo Dejardin D, Garcia Ruiz de Gordejuela A, Fort Lopez-Barajas JM, Armengol Carrasco M; Members of the Obesity Section of the Spanish Surgical Association Collaborative Group. Seeking an Initial-Weight-Independent Metric in a Mediterranean Cohort of Gastric Bypass Patients: the %AWL Revisited. Obes Surg. 2021 Apr;31(4):1524-1532. doi: 10.1007/s11695-020-05154-3. Epub 2021 Jan 4."}, {"pmid"=>"32081378", "type"=>"BACKGROUND", "citation"=>"Caixas A, Villaro M, Arraiza C, Montalva JC, Lecube A, Fernandez-Garcia JM, Corio R, Bellido D, Llisterri JL, Tinahones FJ. SEEDO-SEMERGEN consensus document on continuous care of obesity between Primary Care and Specialist Hospital Units 2019. Med Clin (Barc). 2020 Sep 25;155(6):267.e1-267.e11. doi: 10.1016/j.medcli.2019.10.014. Epub 2020 Feb 17. English, Spanish."}, {"pmid"=>"32640531", "type"=>"BACKGROUND", "citation"=>"Martinez-Ortega AJ, Olveira G, Pereira-Cunill JL, Arraiza-Irigoyen C, Garcia-Almeida JM, Irles Rocamora JA, Molina-Puerta MJ, Molina Soria JB, Rabat-Restrepo JM, Rebollo-Perez MI, Serrano-Aguayo MP, Tenorio-Jimenez C, Vilches-Lopez FJ, Garcia-Luna PP. Recommendations Based on Evidence by the Andalusian Group for Nutrition Reflection and Investigation (GARIN) for the Pre- and Postoperative Management of Patients Undergoing Obesity Surgery. Nutrients. 2020 Jul 6;12(7):2002. doi: 10.3390/nu12072002."}, {"pmid"=>"31342249", "type"=>"BACKGROUND", "citation"=>"Vilallonga R, Pereira-Cunill JL, Morales-Conde S, Alarcon I, Breton I, Dominguez-Adame E, Ferrer JV, Ruiz-de-Gordejuela AG, Goday A, Lecube A, Garcia-Almenta EM, Rubio MA, Tinahones FJ, Garcia-Luna PP. A Spanish Society joint SECO and SEEDO approach to the Post-operative management of the patients undergoing surgery for obesity. Obes Surg. 2019 Dec;29(12):3842-3853. doi: 10.1007/s11695-019-04043-8."}, {"pmid"=>"27543006", "type"=>"BACKGROUND", "citation"=>"Lecube A, Monereo S, Rubio MA, Martinez-de-Icaya P, Marti A, Salvador J, Masmiquel L, Goday A, Bellido D, Lurbe E, Garcia-Almeida JM, Tinahones FJ, Garcia-Luna PP, Palacio E, Gargallo M, Breton I, Morales-Conde S, Caixas A, Menendez E, Puig-Domingo M, Casanueva FF. Prevention, diagnosis, and treatment of obesity. 2016 position statement of the Spanish Society for the Study of Obesity. Endocrinol Diabetes Nutr. 2017 Mar;64 Suppl 1:15-22. doi: 10.1016/j.endonu.2016.07.002. Epub 2016 Aug 16. No abstract available. English, Spanish."}, {"pmid"=>"35514242", "type"=>"BACKGROUND", "citation"=>"Yarnoz-Esquiroz P, Olazaran L, Aguas-Ayesa M, Perdomo CM, Garcia-Goni M, Silva C, Fernandez-Formoso JA, Escalada J, Montecucco F, Portincasa P, Fruhbeck G. 'Obesities': Position statement on a complex disease entity with multifaceted drivers. Eur J Clin Invest. 2022 Jul;52(7):e13811. doi: 10.1111/eci.13811. Epub 2022 May 12."}, {"pmid"=>"35342930", "type"=>"BACKGROUND", "citation"=>"Linares-Pineda TM, Boughanem H, Gutierrez-Repiso C, Macias-Gonzalez M, Andres-Leon E, Rojo-Martinez G, Valdes S, Tinahones FJ, Morcillo S. Epigenetic changes in the metabolically healthy obese: A case-control versus a prospective study. Eur J Clin Invest. 2022 Aug;52(8):e13783. doi: 10.1111/eci.13783. Epub 2022 Apr 11. No abstract available."}, {"pmid"=>"34846686", "type"=>"BACKGROUND", "citation"=>"Martinez MC, Meli EF, Candia FP, Filippi F, Vilallonga R, Cordero E, Hernandez I, Eguinoa AZ, Burgos R, Vila A, Simo R, Ciudin A. The Impact of Bariatric Surgery on the Muscle Mass in Patients with Obesity: 2-Year Follow-up. Obes Surg. 2022 Mar;32(3):625-633. doi: 10.1007/s11695-021-05815-x. Epub 2021 Nov 30."}, {"pmid"=>"34253348", "type"=>"BACKGROUND", "citation"=>"Lecube A, Ciudin A. A long and stony road to the correct treatment of obesity. Med Clin (Barc). 2021 Aug 27;157(4):176-177. doi: 10.1016/j.medcli.2021.06.004. Epub 2021 Jul 10. No abstract available. English, Spanish."}, {"pmid"=>"34146246", "type"=>"BACKGROUND", "citation"=>"Torrego-Ellacuria M, Barabash A, Larrad-Sainz A, Hernandez-Nunez GM, Matia-Martin P, Perez-Ferre N, Marcuello C, Sanchez-Pernaute A, Torres AJ, Calle-Pascual AL, Rubio MA. Weight Regain Outcomes After Bariatric Surgery in the Long-term Follow-up: Role of Preoperative Factors. Obes Surg. 2021 Sep;31(9):3947-3955. doi: 10.1007/s11695-021-05497-5. Epub 2021 Jun 19."}, {"pmid"=>"34638758", "type"=>"BACKGROUND", "citation"=>"Gutierrez-Repiso C, Linares-Pineda TM, Gonzalez-Jimenez A, Aguilar-Lineros F, Valdes S, Soriguer F, Rojo-Martinez G, Tinahones FJ, Morcillo S. Epigenetic Biomarkers of Transition from Metabolically Healthy Obesity to Metabolically Unhealthy Obesity Phenotype: A Prospective Study. Int J Mol Sci. 2021 Sep 27;22(19):10417. doi: 10.3390/ijms221910417."}, {"pmid"=>"34683180", "type"=>"BACKGROUND", "citation"=>"Ciudin A, Fidilio E, Gutierrez-Carrasquilla L, Caixas A, Vilarrasa N, Pellitero S, Simo-Servat A, Vilallonga R, Ruiz A, de la Fuente M, Luna A, Sanchez E, Rigla M, Hernandez C, Salas E, Simo R, Lecube A. A Clinical-Genetic Score for Predicting Weight Loss after Bariatric Surgery: The OBEGEN Study. J Pers Med. 2021 Oct 17;11(10):1040. doi: 10.3390/jpm11101040."}, {"pmid"=>"33601956", "type"=>"BACKGROUND", "citation"=>"Nicolau J, Dotres K, Ayala L, Rodriguez I, Pascual S, Sanchis P, Bonet A, Tamayo MI, Arteaga M, Fortuny R, Cifuentes A, Masmiquel L. Long-Term Prevalence of Food Addiction Among Bariatric Surgery Patients: Influence on Metabolic and Psychological Outcomes. Metab Syndr Relat Disord. 2021 Apr;19(3):152-158. doi: 10.1089/met.2020.0079. Epub 2021 Feb 18."}, {"pmid"=>"34345955", "type"=>"BACKGROUND", "citation"=>"Fidilio E, Comas M, Giribes M, Cardenas G, Vilallonga R, Palma F, Pelaez RB, Simo R, Ciudin A. Evaluation of Resting Energy Expenditure in Subjects with Severe Obesity and Its Evolution After Bariatric Surgery. Obes Surg. 2021 Oct;31(10):4347-4355. doi: 10.1007/s11695-021-05578-5. Epub 2021 Aug 3."}, {"pmid"=>"33923789", "type"=>"BACKGROUND", "citation"=>"Cornejo-Pareja I, Molina-Vega M, Gomez-Perez AM, Damas-Fuentes M, Tinahones FJ. Factors Related to Weight Loss Maintenance in the Medium-Long Term after Bariatric Surgery: A Review. J Clin Med. 2021 Apr 16;10(8):1739. doi: 10.3390/jcm10081739."}, {"pmid"=>"33147793", "type"=>"BACKGROUND", "citation"=>"Alvarez-Bermudez MD, Martin-Reyes F, Ocana-Wilhelmi L, Moreno-Ruiz FJ, Torres JA, Fernandez-Garcia D, Valdes S, Moreno-Morales N, Garcia-Fuentes E, Tinahones FJ, Garrido-Sanchez L. Variables Associated with Short-Term Weight Loss in a Cohort of Patients with Morbid Obesity According to Age and Three Types of Bariatric Surgery. J Clin Med. 2020 Nov 2;9(11):3537. doi: 10.3390/jcm9113537."}, {"pmid"=>"32283783", "type"=>"BACKGROUND", "citation"=>"Hollanda A, Lecube A, Rubio MA, Sanchez E, Vilarrasa N, Oliva JG, Fernandez-Soto ML, Salas-Salvado J, Ballesteros-Pomar MD, Ciudin A, Torres F, Vidal C, Morales MJ, Valdes S, Pellitero S, Minambres I, Masmiquel L, Goday A, Suarez L, Flores L, Bueno M, Caixas A, Breton I, Camara R, Olbeyra R, Penso R, Jose de la Cruz M, Simo-Servat A, Pereyra-Garcia FM, Lopez-Mezquita ET, Gils A, Fidilio E, Bandres O, Martinez A, Abuin J, Marques-Pamies M, Tuneu L, Arteaga M, Castaner O, Goni F, Arrizabalaga C, Botana MA, Calanas A, Rebollo A. New Metrics to Assess Type 2 Diabetes After Bariatric Surgery: The \"Time-Within-Remission Range\". J Clin Med. 2020 Apr 9;9(4):1070. doi: 10.3390/jcm9041070."}, {"pmid"=>"30862367", "type"=>"BACKGROUND", "citation"=>"Palau-Rodriguez M, Garcia-Aloy M, Minarro A, Bernal-Lopez MR, Brunius C, Gomez-Huelgas R, Landberg R, Tinahones FJ, Andres-Lacueva C. Effects of a long-term lifestyle intervention on metabolically healthy women with obesity: Metabolite profiles according to weight loss response. Clin Nutr. 2020 Jan;39(1):215-224. doi: 10.1016/j.clnu.2019.01.018. Epub 2019 Feb 16."}, {"pmid"=>"31112015", "type"=>"BACKGROUND", "citation"=>"Serrano JCE, Baena-Fustegueras JA, Martin-Gari M, Rassendren H, Cassanye A, Naudi A, Lopez-Cano C, Sanchez E, de la Fuente-Juarez MC, Herrerias Gonzalez F, Olsina Kissler JJ, Lecube A, Portero-Otin M. Adipose Tissue Protein Glycoxidation is Associated with Weight-Loss Potential. Obesity (Silver Spring). 2019 Jul;27(7):1133-1140. doi: 10.1002/oby.22501. Epub 2019 May 21."}, {"pmid"=>"31277226", "type"=>"BACKGROUND", "citation"=>"Ciudin A, Fidilio E, Ortiz A, Pich S, Salas E, Mesa J, Hernandez C, Simo-Servat O, Lecube A, Simo R. Genetic Testing to Predict Weight Loss and Diabetes Remission and Long-Term Sustainability after Bariatric Surgery: A Pilot Study. J Clin Med. 2019 Jul 3;8(7):964. doi: 10.3390/jcm8070964."}, {"pmid"=>"31608009", "type"=>"BACKGROUND", "citation"=>"Cornejo-Pareja I, Clemente-Postigo M, Tinahones FJ. Metabolic and Endocrine Consequences of Bariatric Surgery. Front Endocrinol (Lausanne). 2019 Sep 19;10:626. doi: 10.3389/fendo.2019.00626. eCollection 2019."}, {"pmid"=>"30121853", "type"=>"BACKGROUND", "citation"=>"Arteaga-Gonzalez IJ, Martin-Malagon AI, Ruiz de Adana JC, de la Cruz Vigo F, Torres-Garcia AJ, Carrillo-Pallares AC. Bariatric Surgery Waiting Lists in Spain. Obes Surg. 2018 Dec;28(12):3992-3996. doi: 10.1007/s11695-018-3453-z."}, {"pmid"=>"28244776", "type"=>"BACKGROUND", "citation"=>"Nicolau J, Simo R, Sanchis P, Ayala L, Fortuny R, Rivera R, Masmiquel L. Effects of depressive symptoms on clinical outcomes, inflammatory markers and quality of life after a significant weight loss in a bariatric surgery sample. Nutr Hosp. 2017 Feb 1;34(1):81-87. doi: 10.20960/nh.979."}, {"pmid"=>"28393901", "type"=>"BACKGROUND", "citation"=>"Morcillo S, Martin-Nunez GM, Garcia-Serrano S, Gutierrez-Repiso C, Rodriguez-Pacheco F, Valdes S, Gonzalo M, Rojo-Martinez G, Moreno-Ruiz FJ, Rodriguez-Canete A, Tinahones F, Garcia-Fuentes E. Changes in SCD gene DNA methylation after bariatric surgery in morbidly obese patients are associated with free fatty acids. Sci Rep. 2017 Apr 10;7:46292. doi: 10.1038/srep46292."}]}, "descriptionModule"=>{"briefSummary"=>"Obesity is a complex chronic disease, in which both genetic and environmental factors are involved, that shows a great heterogeneity in the response to different weight loss programs. Identifying patients as responder or no responder to the different obesity treatment options is a concept of great interest, both due to the high prevalence of obesity and its high consumption of resources. More than 500,000 surgeries are performed every year around the world, of which approximately 30% will present unsatisfactory results.\n\nThe general objective is to carry out a multi-omics approach for the discovery and validation of markers of weight response to bariatric surgery (BS) in a large sample of people with severe obesity (n=6,966 men and women who underwent sleeve gastrectomy or gastric bypass, including an additional external validation set). Thus, the investigators want to know the integrated contribution of several genomic markers (Genome Wide Association study, GWAs), new clinical and analytical variables (human exposome concept) and gender perspective to the prediction of response to the intervention at 12 month and its long-term longitudinal maintenance (3 years). The investigators intend, therefore, to provide new evidence to advance towards precision medicine. The investigators will focus our attention also on identifying those patients who, after being classified at the weight loss nadir as responders experienced weight regain."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"This multicenter retrospective study will be aimed at 6,966 obese patients undergoing BS, whose surgical technique (sleeve gastrectomy vs gastric bypass) has been performed at least 3 years before, evaluating the best combination of genetic and exposomal characteristics (clinical and analytical) that will predict which patients will be responders and non-responders in terms of weight loss.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Men and women between the ages of 18 and 65 at the time of surgery\n* SG or RYBP as bariatric procedure.\n* With a BMI≥35.0 kg/m2 with one or more comorbidities or a BMI\\>40.0 kg/m2 at the time of surgery.\n* Provision of an informed consent form signed and personally dated by the patient.\n* With available baseline data (anthropometric, analytical, surgical procedure, pharmacological therapies, and obesity-related comorbidities).\n\nExclusion Criteria:\n\n* Any previous gastrointestinal surgery\n* Treatment with any approved antiobesity drug in Spain (orlistat, liraglutide 3.0 mg and/or naltrexone/bupropion extended release) or systemic glucocorticoids for more than 4 consecutive weeks during the 3 years following BS\n* End stage kidney disease (eGFR \\<15 ml/min/1.73m2) or liver cirrhosis at baseline\n* Patients who developed any major medical conditions that limits the practice of a healthy life within normal limits (advanced cardiovascular disease or heart failure, stroke with neurological sequelae, chronic pulmonary obstructive disease with dyspnea at minimal exertion, severe joint pathology, end stage renal failure, or active cancer)\n* Known type 1 diabetes or LADA diabetes\n* Women who become pregnant during the follow-up period\n* Current drug or alcohol abuse\n* Uncontrolled psychiatric illness or eating disorders developed during the follow-up period."}, "identificationModule"=>{"nctId"=>"NCT06226194", "acronym"=>"GENBASU", "briefTitle"=>"Genetic Susceptibility to Predict Weight Loss After Bariatric Surgery", "organization"=>{"class"=>"OTHER", "fullName"=>"Institut de Recerca Biomèdica de Lleida"}, "officialTitle"=>"Genetic Susceptibility to Predict Weight Loss After Bariatric Surgery", "orgStudyIdInfo"=>{"id"=>"IRBLleida"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Lleida", "description"=>"Saliva sample collection and questionnaire"}, {"label"=>"Barcelona", "description"=>"Saliva sample collection and questionnaire"}, {"label"=>"Madrid", "description"=>"Saliva sample collection and questionnaire"}, {"label"=>"Málaga", "description"=>"Saliva sample collection and questionnaire"}, {"label"=>"Santiago de Compostela", "description"=>"Saliva sample collection and questionnaire"}, {"label"=>"Pamplona", "description"=>"Saliva sample collection and questionnaire"}, {"label"=>"León", "description"=>"Saliva sample collection and questionnaire"}, {"label"=>"A Coruña", "description"=>"Saliva sample collection and questionnaire"}, {"label"=>"Mallorca", "description"=>"Saliva sample collection and questionnaire"}, {"label"=>"Tenerife", "description"=>"Saliva sample collection and questionnaire"}, {"label"=>"Las Palmas", "description"=>"Saliva sample collection and questionnaire"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"25198", "city"=>"Lleida", "state"=>"Leida", "status"=>"RECRUITING", "country"=>"Spain", "contacts"=>[{"name"=>"Albert Lecube Torelló, PhD", "role"=>"CONTACT", "email"=>"alecube@gmail.com", "phone"=>"973702201"}], "facility"=>"IRBLleida", "geoPoint"=>{"lat"=>41.61674, "lon"=>0.62218}}], "centralContacts"=>[{"name"=>"Albert Lecube Torelló, PhD", "role"=>"CONTACT", "email"=>"alecube@gmail.com", "phone"=>"0034973705183"}, {"name"=>"Eva López", "role"=>"CONTACT", "email"=>"elopez@irblleida.cat", "phone"=>"0034973706636"}], "overallOfficials"=>[{"name"=>"Albert Lecube Torelló, PhD", "role"=>"STUDY_CHAIR", "affiliation"=>"Institut de Recerca Biomèdica de Lleida"}, {"name"=>"Rafael Simo, PhD", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Vall d'Hebron Research Institute"}, {"name"=>"Miguel Angel Rubio, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Instituto de Investigación Sanitaria Hospital Clínico San Carlos"}, {"name"=>"Francisco Tinahones, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Instituto de Investigación Biomédica de Málaga"}, {"name"=>"Javier Escalada, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Clínica Universidad de Navarra Institute"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Institut de Recerca Biomèdica de Lleida", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"ISCIII", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Head of Endocrinology Department Arnau de Vilanova University Hospital", "investigatorFullName"=>"Albert Lecube Torello", "investigatorAffiliation"=>"Institut de Recerca Biomèdica de Lleida"}}}}
