Systemic and Tissue Inflammatory Biomarkers in Acute Appendicitis (STIBAA)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Emre B Akçay
- 電話番号：+90 535 711 92 21
- メール：dr.eberatakcay@gmail.com
研究場所
-
-
Istanbul
-
Istanbul、Istanbul、トルコ（Türkiye）、34668
- 募集
- Haydarpaşa Numune Training and Research Hospital
-
コンタクト：
- Emre B Akçay
- 電話番号：+90 535 711 92 21
- メール：dr.eberatakcay@gmail.com
-
コンタクト：
- Ali Sürmelioğlu
- 電話番号：+90 505 562 55 46
- メール：surmeliali@yahoo.com
-
副調査官：
- Emre B Akçay
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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. |
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serum/Plasma Presepsin Levels
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
White Blood Cell Count
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
協力者と研究者
捜査官
- スタディディレクター：Ali Sürmelioğlu、Haydarpasa Numune Training and Research Hospital
出版物と役立つリンク
一般刊行物
- Berhuni MS, Yonder H, Elkan H, Koyuncu MH, Ozgul F, Tatli F, Ozgonul A, Uzunkoy A. Diagnostic Value of Systemic Immune Inflammation Index in Identifying Complicated Acute Appendicitis Cases. Cureus. 2024 Nov 5;16(11):e73046. doi: 10.7759/cureus.73046. eCollection 2024 Nov.
- Yesilalioglu S, Az A, Sogut O, Ergenc H, Demirel I. Systemic inflammatory markers for distinguishing uncomplicated and complicated acute appendicitis in adult patients. North Clin Istanb. 2023 Jul 31;10(4):507-513. doi: 10.14744/nci.2022.79027. eCollection 2023.
- Duyan M, Vural N. Assessment of the Diagnostic Value of Novel Biomarkers in Adult Patients With Acute Appendicitis: A Cross-Sectional Study. Cureus. 2022 Dec 7;14(12):e32307. doi: 10.7759/cureus.32307. eCollection 2022 Dec.
- de Jonge J, Scheijmans JCG, van Rossem CC, van Geloven AAW, Boermeester MA, Bemelman WA; Snapshot Appendicitis Collaborative Study group. Normal inflammatory markers and acute appendicitis: a national multicentre prospective cohort analysis. Int J Colorectal Dis. 2021 Jul;36(7):1507-1513. doi: 10.1007/s00384-021-03933-7. Epub 2021 Apr 27.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 26/337
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。