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NCT07026552: APIDeLeG
Proteomic and Histological Analysis of Ligamentum Flavum in Lumbar Stenosis
trial in Spinal Stenosis of Lumbar Region in 100 participants. Currently enrolling.
1 March 2027
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 15 June 2025 |
| Primary completion | 1 March 2027 |
| Estimated completion | 1 March 2028 |
| Sites | 1 location across Italy |
Conditions studied
- Spinal Stenosis of Lumbar Region — all drugs for Spinal Stenosis of Lumbar Region →
- Spine Degeneration — all drugs for Spine Degeneration →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
Adults 50 to 85, any sex, with Spinal Stenosis of Lumbar Region or Spine Degeneration. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07026552 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 7 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07026552.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing