NCT07026552 Proteomic and Histological Analysis of Ligamentum Flavum in Lumbar Stenosis
| NCT ID | NCT07026552 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Spinal Stenosis of Lumbar Region |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-06-15 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-06-15 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background Lumbar spinal stenosis (LSS) is a common condition characterized by spinal canal narrowing, often linked to ligamentum flavum hypertrophy (LFH) and degeneration. Fibrotic processes involving elastin and collagen alterations contribute to LF thickening and spinal instability. Despite progress, the molecular mechanisms underlying LFH remain unclear, necessitating targeted diagnostic and therapeutic strategies. Objective This study aims to analyze the proteomic and histological changes in LFH associated with LSS, correlating molecular signatures with imaging and surgical findings to identify potential therapeutic targets. Methods LF samples from LSS patients undergoing surgery will be analyzed using mass spectrometry-based proteomics and histology to identify biomarkers and molecular pathways. Correlations between imaging, intraoperative findings, and molecular profiles will be assessed. Expected Results The study aims to identify specific biomarkers and molecular pathways involved in LFH, linking them to clinical and imaging findings. Statistical analyses will evaluate associations between molecular alterations and surgical outcomes to define therapeutic targets. Significance By identifying molecular markers of LFH, this research aims to improve LSS diagnosis and treatment, potentially guiding targeted therapies to slow disease progression and enhance patient outcomes. Study Design A multidisciplinary team from Fondazione Policlinico Universitario Agostino Gemelli and Università Cattolica del Sacro Cuore will conduct the study, ensuring robust data integration and statistical evaluation. Conclusion This comprehensive study will provide valuable insights into the molecular and histological modifications associated with LFH in LSS, paving the way for new therapeutic approaches to improve patient outcomes and satisfaction.
Eligibility Criteria
Inclusion Criteria: * Radiological (CT and/or MRI) and clinical evidence of lumbar spinal stenosis (LSS). * Age range: 50-85 years. * Signed informed consent, medical records release form, and HIPAA authorization form (or equivalent according to local regulations), reviewed and signed by the patient or legally authorized representatives. Exclusion Criteria: * Pediatric population and individuals under 50 years of age. * Concomitant genetic musculoskeletal disorders. * History of trauma. * Spinal infections (spondylodiscitis, osteomyelitis, abscess, etc.). * Presence of spinal tumors or other neoplasms.
Contact & Investigator
Giuseppe La Rocca
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Agostino Gemelli IRCSS
Frequently Asked Questions
Who can join the NCT07026552 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 85 Years, studying Spinal Stenosis of Lumbar Region. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07026552 currently recruiting?
Yes, NCT07026552 is actively recruiting participants. Contact the research team at giuseppe.larocca@policlinicogemelli.it for enrollment information.
Where is the NCT07026552 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT07026552 clinical trial?
NCT07026552 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Giuseppe La Rocca at Fondazione Policlinico Agostino Gemelli IRCSS. The trial plans to enroll 100 participants.