protocolSection identificationModule nctId: NCT06349226, orgStudyIdInfo id: DISCOLAB, briefTitle: Identification of Biomarkers and Molecular Targets Involved on Intervertebral Disc Degeneration and Discogenic Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-05-22, primaryCompletionDateStruct date: 2025-05-21, completionDateStruct date: 2025-05-21, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: Low back pain, associated with intrinsic disorders of the spine, is a very frequent clinical condition that is accompanied by high morbidity with effects both on psychosocial aspects, and health care system. It occurs in approximately 80% of the population throughout their lives. Most low back pain is associated with intervertebral disc degeneration (IDD) associated with neuroinflammation and pain. In this context, the study of sphingolipid metabolism can play an important role in the identification of new molecules responsible for the degenerative process. Sphingolipids, in fact, are a class of molecules that are implicated in multiple signal pathways, such as proliferation, degradation of the extracellular matrix, inflammatory state, apoptosis and migration. In particular, sphingosine-1-phosphate (S1P), an intermediate of sphingolipid metabolism, acts as a pro-inflammatory mediator, predominantly in the extracellular environment, regulating important cellular properties related to inflammatory potential and pain. The objective of this study is to characterize the degenerative process in cells isolated from degenerated human intervertebral discs from both at cellular and molecular levels in order to identify new targets implicated in degenerative processes, including sphingolipid signaling pathway., conditionsModule conditions: Intervertebral Disc Degeneration, conditions: Discogenic Pain, conditions: Discogenic Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: cell isolation from intervertebral disc tissue and biomarker investigation, outcomesModule primaryOutcomes measure: Characterization of degenerated intervertebral disc cells, secondaryOutcomes measure: Development of cellular model platform, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, status: RECRUITING, city: Milan, zip: 20122, country: Italy, contacts name: Giovanni Marfia, MD, Phd, role: CONTACT, phone: 0255035502, phoneExt: +39, email: giovanni.marfia@policlinico.mi.it, contacts name: Stefania E Navone, PhD, role: CONTACT, phone: 0255034268, phoneExt: +39, email: stefania.navone@policlinico.mi.it, contacts name: Mauro Pluderi, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Giovanni Marfia, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Stefania E Navone, PhD, role: SUB_INVESTIGATOR, contacts name: Laura Guarnaccia, PhD, role: SUB_INVESTIGATOR, contacts name: Laura Begani, MSc, role: SUB_INVESTIGATOR, contacts name: Marco Locatelli, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Stefano Borsa, MD, role: SUB_INVESTIGATOR, contacts name: Giulio Bertani, MD, role: SUB_INVESTIGATOR, contacts name: Claudia Fanizzi, MD, role: SUB_INVESTIGATOR, contacts name: Giorgio Fiore, MD, role: SUB_INVESTIGATOR, contacts name: Luigi Schisano, MD, role: SUB_INVESTIGATOR, contacts name: Manuela Caroli, MD, role: SUB_INVESTIGATOR, contacts name: Antonella Ampollini, MD, role: SUB_INVESTIGATOR, contacts name: Elena Pirola, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False