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Systemic and Tissue Inflammatory Biomarkers in Acute Appendicitis (STIBAA)

3 novembre 2026 aggiornato da: Ali Sürmelioğlu, Haydarpasa Numune Training and Research Hospital

Evaluation of Systemic and Tissue Level Inflammatory Response in Acute Appendicitis Using Multiple Biomarkers

This observational study aims to evaluate inflammatory responses in the blood and appendix tissue of adults diagnosed with acute appendicitis. Acute appendicitis is a common condition that often requires emergency surgery. Although clinical examinations, laboratory tests, and imaging methods are used for diagnosis, distinguishing uncomplicated from complicated appendicitis can sometimes be challenging.

The study aims to investigate whether inflammatory biomarkers measured in blood and appendix tissue are associated with the severity of acute appendicitis and whether these biomarkers may help improve the assessment of the disease.

The main questions this study aims to answer are:

  • How are inflammatory biomarkers in blood and appendix tissue associated with the severity of acute appendicitis?
  • Do these biomarkers differ between patients with uncomplicated and complicated acute appendicitis?
  • Are inflammatory biomarker levels associated with clinical findings and commonly used laboratory indicators? Approximately 140 adult patients diagnosed with acute appendicitis and undergoing appendectomy will be included in the study.

Participants will receive standard medical and surgical care. Blood samples obtained during routine clinical care and appendix tissue samples collected during surgery will be used for additional laboratory analyses. No additional invasive procedures or changes to standard treatment will be required for research purposes.

The findings may help researchers better understand inflammatory processes in acute appendicitis and identify biomarkers that could support clinical assessment and decision-making.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Background and Rationale:

Acute appendicitis is one of the most common causes of acute abdominal pain requiring emergency surgical intervention. Accurate assessment of disease severity, particularly the differentiation between uncomplicated and complicated acute appendicitis, remains an important clinical challenge.

Although clinical scoring systems, laboratory parameters, and imaging modalities contribute to diagnosis and clinical decision-making, their individual diagnostic performance may be limited. Systemic inflammatory markers, including C-reactive protein (CRP), neutrophil-to-lymphocyte ratio (NLR), and platelet-to-lymphocyte ratio (PLR), have been investigated as indicators of inflammatory activity. However, circulating inflammatory markers may not fully reflect the local inflammatory processes occurring within the appendix.

The simultaneous evaluation of systemic and tissue-level inflammatory biomarkers may provide a more comprehensive understanding of the inflammatory response in acute appendicitis and its relationship with disease severity.

Study Objective:

The primary objective of this prospective observational study is to evaluate systemic and tissue-level inflammatory responses in patients with acute appendicitis using multiple biomarkers.

The study will investigate the relationships between circulating inflammatory markers, local inflammatory biomarkers in appendix tissue, clinical findings, and the severity of acute appendicitis.

Study Design and Population:

This is a prospective, observational, single-center study conducted in the Department of General Surgery at Haydarpaşa Numune Training and Research Hospital, Istanbul, Türkiye.

Approximately 140 adult patients diagnosed with acute appendicitis and undergoing appendectomy will be enrolled according to the predefined eligibility criteria.

Patients will receive standard diagnostic evaluation and surgical treatment. No experimental therapeutic intervention or alteration of routine clinical management will be performed as part of the study.

Clinical Assessment:

Clinical and demographic information will be collected from eligible participants. Preoperative clinical evaluation will include the Alvarado Score and the Appendicitis Inflammatory Response (AIR) Score.

Clinical findings, routine laboratory results, imaging findings, operative observations, and histopathological examination results will be evaluated in relation to inflammatory biomarker measurements.

Biological Sample Collection and Biomarker Assessment:

Blood samples collected as part of routine clinical evaluation will be used for systemic inflammatory biomarker analysis. Serum or plasma obtained from these samples will be processed under appropriate laboratory conditions and stored at -80°C until analysis.

The systemic inflammatory parameters evaluated will include CRP, NLR, PLR, systemic inflammatory index, procalcitonin, ferritin, presepsin, erythrocyte sedimentation rate, CD68, cyclooxygenase-2 (COX-2), inducible nitric oxide synthase (iNOS), transforming growth factor-beta (TGF-β), calprotectin, and isoprostane.

Appendix tissue samples will be obtained from surgically removed specimens. Tissue collection will be performed without interfering with routine histopathological examination.

Tissue samples designated for biochemical analysis will be transported under cold-chain conditions, stored at -80°C, and homogenized using a standardized laboratory procedure.

Local inflammatory biomarkers assessed in appendix tissue will include presepsin, CD68, COX-2, iNOS, TGF-β, calprotectin, and isoprostane.

Statistical Analysis:

Statistical analyses will be performed using appropriate statistical software. The distribution of continuous variables will be assessed using the Kolmogorov-Smirnov or Shapiro-Wilk test. Normally distributed variables will be expressed as mean and standard deviation, whereas non-normally distributed variables will be presented as median and interquartile range.

Comparisons between groups will be performed using the independent-samples t-test or Mann-Whitney U test, as appropriate. Categorical variables will be analyzed using the chi-square test or Fisher's exact test.

For comparisons involving more than two groups, analysis of variance or the Kruskal-Wallis test will be used according to data distribution.

Correlations between inflammatory biomarkers and clinical scores will be assessed using Pearson or Spearman correlation analysis. Receiver operating characteristic (ROC) curve analysis will be used to evaluate the discriminatory performance of biomarkers for distinguishing complicated from uncomplicated acute appendicitis.

Multivariable logistic regression analysis will be considered to identify independent predictors of disease severity.

A p-value of less than 0.05 will be considered statistically significant.

Expected Scientific Contribution:

By evaluating circulating and tissue-level inflammatory biomarkers together, this study aims to provide a more comprehensive characterization of the inflammatory response in acute appendicitis.

The findings may contribute to identifying biomarkers associated with disease severity and may support future research on improved diagnostic assessment and clinical decision-making.

Tipo di studio

Osservativo

Iscrizione (Stimato)

60

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Turchia (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turchia (Türkiye), 34668
        • Reclutamento
        • Haydarpaşa Numune Training and Research Hospital
        • Contatto:
        • Contatto:
        • Sub-investigatore:
          • Emre B Akçay

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Adult patients presenting to the General Surgery Department of Haydarpaşa Numune Training and Research Hospital with suspected acute appendicitis and scheduled for appendectomy will constitute the study population. Participants will be recruited consecutively from patients undergoing routine clinical and surgical care at this hospital.

Descrizione

Inclusion Criteria:

Adults aged 18-65 years. Willingness to participate in the study and provision of written informed consent.

Suspected acute appendicitis based on clinical, laboratory, and/or imaging findings.

Scheduled for appendectomy following general surgical evaluation. Availability of an appendectomy specimen suitable for postoperative histopathological examination.

Availability of sufficient clinical and laboratory records for study evaluation.

Exclusion Criteria:

Age younger than 18 years or older than 65 years. Refusal to participate or failure to provide written informed consent. Presence of an active infection that may affect the systemic inflammatory response during the preoperative period.

Concomitant active infectious diseases, including pneumonia, urinary tract infection, or sepsis.

Chronic inflammatory or autoimmune diseases, including rheumatoid arthritis, inflammatory bowel disease, or systemic lupus erythematosus.

History of malignancy or active malignancy. Chronic renal failure or advanced liver failure. Use of immunosuppressive therapy. Use of corticosteroids, chemotherapy, or biological agents. Preoperative use of antibiotics or anti-inflammatory medications at a level that may significantly affect inflammatory biomarker measurements.

Pregnancy or breastfeeding. Identification of additional intra-abdominal pathology unrelated to appendicitis during appendectomy.

Failure to confirm acute appendicitis on postoperative histopathological examination.

Inadequate biological sample quantity or failure to store biological samples under appropriate conditions.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: COHORT
  • Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Patients Undergoing Appendectomy for Acute Appendicitis

This cohort includes adult patients undergoing appendectomy for acute appendicitis. Blood samples and appendix tissue specimens obtained during routine clinical care and surgery will be analyzed to evaluate systemic and tissue-level inflammatory biomarkers and their associations with clinical findings and disease severity. All participants will receive standard medical and surgical care without any research-related modifications to their treatment.
Procedura: appendectomy

Patients diagnosed with acute appendicitis will undergo appendectomy as part of routine clinical care. The surgical procedure will be performed according to standard clinical indications and will not be assigned or modified by the study protocol. Blood samples and surgically removed appendix tissue specimens will be used for inflammatory biomarker analyses. No experimental surgical intervention or modification of standard treatment will be performed.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Serum/Plasma Presepsin Levels
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

Presepsin concentrations will be measured in preoperative peripheral venous blood samples using commercially available ELISA kits according to the manufacturer's instructions. Serum or plasma presepsin levels will be expressed in ng/mL (provisional unit, subject to confirmation based on the selected assay). The measurements will be used to evaluate systemic inflammatory responses and their association with the severity of acute appendicitis.
Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue Presepsin Levels
Lasso di tempo: During appendectomy (single tissue collection).

Presepsin levels will be measured in appendix tissue homogenates prepared from surgically removed appendectomy specimens using commercially available ELISA kits according to the manufacturer's instructions. Results will be normalized to total tissue protein content and expressed in ng/mg total protein (provisional unit, subject to confirmation based on the selected assay and normalization method). The measurements will be used to evaluate local inflammatory responses and their association with the severity of acute appendicitis.
During appendectomy (single tissue collection).
Serum/Plasma CD68 Levels
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

CD68 levels will be measured in preoperative peripheral venous blood samples using commercially available ELISA kits according to the manufacturer's instructions. Serum or plasma CD68 levels will be expressed in ng/mL (provisional unit, subject to confirmation based on the selected assay). The measurements will be used to evaluate systemic inflammatory responses and their association with the severity of acute appendicitis.
Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue CD68 Levels
Lasso di tempo: During appendectomy (single tissue collection).

CD68 levels will be measured in appendix tissue homogenates prepared from surgically removed appendectomy specimens using commercially available ELISA kits according to the manufacturer's instructions. Results will be normalized to total tissue protein content and expressed in ng/mg total protein (provisional unit, subject to confirmation based on the selected assay and normalization method). The measurements will be used to evaluate local inflammatory responses and their association with the severity of acute appendicitis.
During appendectomy (single tissue collection).
Serum/Plasma COX-2 Levels
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

Cyclooxygenase-2 (COX-2) levels will be measured in preoperative peripheral venous blood samples using commercially available ELISA kits according to the manufacturer's instructions. Serum or plasma COX-2 levels will be expressed in ng/mL (provisional unit, subject to confirmation based on the selected assay). The measurements will be used to evaluate systemic inflammatory responses and their association with the severity of acute appendicitis.
Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue COX-2 Levels
Lasso di tempo: During appendectomy (single tissue sampling).

Cyclooxygenase-2 (COX-2) levels will be measured in appendix tissue homogenates prepared from surgically removed appendectomy specimens using commercially available ELISA kits according to the manufacturer's instructions. Results will be normalized to total tissue protein content and expressed in ng/mg total protein (provisional unit, subject to confirmation based on the selected assay and normalization method). The measurements will be used to evaluate local inflammatory responses and their association with the severity of acute appendicitis.
During appendectomy (single tissue sampling).
Serum/Plasma iNOS Levels
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

Inducible nitric oxide synthase (iNOS) levels will be measured in preoperative peripheral venous blood samples using commercially available ELISA kits according to the manufacturer's instructions. Serum or plasma iNOS levels will be expressed in ng/mL (provisional unit, subject to confirmation based on the selected assay). The measurements will be used to evaluate systemic inflammatory responses and their association with the severity of acute appendicitis.
Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue iNOS Levels
Lasso di tempo: During appendectomy (single tissue sampling).

Inducible nitric oxide synthase (iNOS) levels will be measured in appendix tissue homogenates prepared from surgically removed appendectomy specimens using commercially available ELISA kits according to the manufacturer's instructions. Results will be normalized to total tissue protein content and expressed in ng/mg total protein (provisional unit, subject to confirmation based on the selected assay and normalization method). The measurements will be used to evaluate local inflammatory responses and their association with the severity of acute appendicitis.
During appendectomy (single tissue sampling).
Serum/Plasma TGF-β Levels
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

Transforming growth factor-beta (TGF-β) levels will be measured in preoperative peripheral venous blood samples using commercially available ELISA kits according to the manufacturer's instructions. Serum or plasma TGF-β levels will be expressed in ng/mL (provisional unit, subject to confirmation based on the selected assay). The measurements will be used to evaluate systemic inflammatory responses and their association with the severity of acute appendicitis.
Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue TGF-β Levels
Lasso di tempo: During appendectomy (single tissue sampling).

Transforming growth factor-beta (TGF-β) levels will be measured in appendix tissue homogenates prepared from surgically removed appendectomy specimens using commercially available ELISA kits according to the manufacturer's instructions. Results will be normalized to total tissue protein content and expressed in ng/mg total protein (provisional unit, subject to confirmation based on the selected assay and normalization method). The measurements will be used to evaluate local inflammatory responses and their association with the severity of acute appendicitis.
During appendectomy (single tissue sampling).
Serum/Plasma Calprotectin Levels
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

Calprotectin concentrations will be measured in preoperative peripheral venous blood samples using commercially available ELISA kits according to the manufacturer's instructions. Serum or plasma calprotectin levels will be expressed in ng/mL (provisional unit, subject to confirmation based on the selected assay). The measurements will be used to evaluate systemic inflammatory responses and their association with the severity of acute appendicitis.
Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue Calprotectin Levels
Lasso di tempo: During appendectomy (single tissue sampling).

Calprotectin concentrations will be measured in appendix tissue homogenates prepared from surgically removed appendectomy specimens using commercially available ELISA kits according to the manufacturer's instructions. Results will be normalized to total tissue protein content and expressed in ng/mg total protein (provisional unit, subject to confirmation based on the selected assay and normalization method). The measurements will be used to evaluate local inflammatory responses and their association with the severity of acute appendicitis.
During appendectomy (single tissue sampling).
Serum/Plasma Isoprostane Levels
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

Isoprostane levels will be measured in preoperative peripheral venous blood samples using commercially available ELISA kits according to the manufacturer's instructions. Serum or plasma isoprostane levels will be expressed in ng/mL (provisional unit, subject to confirmation based on the selected assay). The measurements will be used to evaluate systemic oxidative stress responses and their association with the severity of acute appendicitis.
Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue Isoprostane Levels
Lasso di tempo: During appendectomy (single tissue sampling).

Isoprostane levels will be measured in appendix tissue homogenates prepared from surgically removed appendectomy specimens using commercially available ELISA kits according to the manufacturer's instructions. Results will be normalized to total tissue protein content and expressed in ng/mg total protein (provisional unit, subject to confirmation based on the selected assay and normalization method). The measurements will be used to evaluate local oxidative stress responses and their association with the severity of acute appendicitis.
During appendectomy (single tissue sampling).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
White Blood Cell Count
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

White blood cell count will be obtained from routine preoperative complete blood count results recorded in hospital laboratory records. Values will be expressed as ×10³/µL and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Preoperatively, before appendectomy (single blood sampling).
Absolute Neutrophil Count
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

Absolute neutrophil count will be obtained from routine preoperative complete blood count results recorded in hospital laboratory records. Values will be expressed as ×10³/µL and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Preoperatively, before appendectomy (single blood sampling).
Absolute Lymphocyte Count
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

Absolute lymphocyte count will be obtained from routine preoperative complete blood count results recorded in hospital laboratory records. Values will be expressed as ×10³/µL and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Preoperatively, before appendectomy (single blood sampling).
Platelet Count
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

Platelet count will be obtained from routine preoperative complete blood count results recorded in hospital laboratory records. Values will be expressed as ×10³/µL and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Preoperatively, before appendectomy (single blood sampling).
Hemoglobin Concentration
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

Hemoglobin concentration will be obtained from routine preoperative complete blood count results recorded in hospital laboratory records. Values will be expressed in g/dL and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Preoperatively, before appendectomy (single blood sampling).
Hematocrit
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

Hematocrit will be obtained from routine preoperative complete blood count results recorded in hospital laboratory records. Values will be expressed as a percentage (%) and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Preoperatively, before appendectomy (single blood sampling).
C-Reactive Protein (CRP) Concentration
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

Preoperative C-reactive protein (CRP) concentration will be obtained from routine hospital laboratory records. Values will be expressed in mg/L and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Preoperatively, before appendectomy (single blood sampling).
Procalcitonin Concentration
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

Preoperative procalcitonin concentration will be obtained from available routine hospital laboratory records. Values will be expressed in ng/mL and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Preoperatively, before appendectomy (single blood sampling).
Ferritin Concentration
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

Preoperative ferritin concentration will be obtained from available routine hospital laboratory records. Values will be expressed in ng/mL and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Preoperatively, before appendectomy (single blood sampling).
Erythrocyte Sedimentation Rate (ESR)
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

Preoperative erythrocyte sedimentation rate (ESR) will be obtained from available routine hospital laboratory records. Values will be expressed in mm/hour and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Preoperatively, before appendectomy (single blood sampling).
Neutrophil-to-Lymphocyte Ratio (NLR)
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

The neutrophil-to-lymphocyte ratio (NLR) will be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count obtained from routine preoperative complete blood count results. NLR will be reported as a dimensionless ratio and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Preoperatively, before appendectomy (single blood sampling).
Platelet-to-Lymphocyte Ratio (PLR)
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

The platelet-to-lymphocyte ratio (PLR) will be calculated by dividing the platelet count by the absolute lymphocyte count obtained from routine preoperative complete blood count results. PLR will be reported as a dimensionless ratio and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Preoperatively, before appendectomy (single blood sampling).
Systemic Immune-Inflammation Index (SII)
Lasso di tempo: Preoperatively, before appendectomy (single blood sampling).

The systemic immune-inflammation index (SII) will be calculated as platelet count multiplied by absolute neutrophil count and divided by absolute lymphocyte count, using routine preoperative complete blood count results. Cell counts will be expressed in ×10³/µL for calculation, and SII will be reported in ×10³/µL. Associations with acute appendicitis severity and experimental inflammatory biomarker levels will be evaluated.
Preoperatively, before appendectomy (single blood sampling).
Alvarado Score
Lasso di tempo: Preoperatively, before appendectomy (single clinical assessment).

The Alvarado score will be calculated using preoperative clinical findings and laboratory parameters. The total score ranges from 0 to 10 points, with higher scores indicating a greater clinical likelihood of acute appendicitis. Associations between the score and experimental inflammatory biomarker levels will be evaluated.
Preoperatively, before appendectomy (single clinical assessment).
Appendicitis Inflammatory Response (AIR) Score
Lasso di tempo: Preoperatively, before appendectomy (single clinical assessment).

The Appendicitis Inflammatory Response (AIR) score will be calculated using preoperative clinical findings and laboratory parameters. The total score ranges from 0 to 12 points, with higher scores indicating a greater clinical likelihood of acute appendicitis. Associations between the score and experimental inflammatory biomarker levels will be evaluated.
Preoperatively, before appendectomy (single clinical assessment).
Incidence of Postoperative Complications
Lasso di tempo: From appendectomy through postoperative day 30.

The occurrence of postoperative complications following appendectomy will be assessed using hospital medical records. The outcome will be reported as the number and percentage of patients experiencing at least one postoperative complication during the predefined follow-up period.
From appendectomy through postoperative day 30.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Haydarpasa Numune Training and Research Hospital

Investigatori

  • Direttore dello studio: Ali Sürmelioğlu, Haydarpasa Numune Training and Research Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 luglio 2026

Completamento primario (Stimato)

12 gennaio 2027

Completamento dello studio (Stimato)

27 maggio 2027

Date di iscrizione allo studio

Primo inviato

23 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 novembre 2026

Primo Inserito (Effettivo)

9 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 26/337

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared with external researchers. Clinical, laboratory, and histopathological data will be coded and securely stored to protect participant confidentiality. Access to individual-level data will be restricted to the authorized research team. Study findings will be reported in aggregate form without disclosing identifiable participant information.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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