{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T19:08:11Z","timestamp":1782846491385,"version":"3.54.5"},"reference-count":23,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Res Protoc"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n Oral squamous cell carcinoma (OSCC) is a highly prevalent and aggressive malignancy of the oral cavity, frequently preceded by oral potentially malignant disorder (OPMD). Despite therapeutic advances, survival rates remain unsatisfactory, primarily due to late diagnosis, recurrence, and molecular alterations in histologically tumor-free surgical margins. Programmed cell death ligand-1 (PD-L1), an immune checkpoint molecule, contributes to tumor immune evasion and has been implicated in cancer progression. Its expression in OPMDs and OSCC surgical margins may serve as an early indicator of malignant transformation and recurrence risk.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n This study aims to assess PD-L1 expression in OPMDs and histologically negative surgical margins of OSCC and evaluate their association with 3-year survival outcomes.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n This retrospective cross-sectional study will be conducted over 12 months at a tertiary care hospital in Sawangi Meghe, Wardha, India. Archived formalin-fixed, paraffin-embedded samples of OPMDs and tumor-free surgical margins from OSCC cases (2018\u20102020) will be retrieved. Immunohistochemistry for PD-L1 will be performed using the SP263 clone, and expression will be evaluated using the combined positive score. Demographic, clinical, and survival data will be collected from patient records. Statistical analysis will determine correlations among PD-L1 expression, clinicopathological variables, and 3-year survival.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n The study is expected to provide insights into the role of PD-L1 as a biomarker for early detection, prognostication, and risk stratification in patients with OPMDs and OSCC. Data collection and immunohistochemical analysis have not yet commenced at the time of submission.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n By evaluating PD-L1 expression in premalignant lesions and histologically negative margins, this study aims to identify molecular predictors of OSCC progression and survival. The findings may help establish PD-L1 as a prognostic biomarker and support its integration into precision oncology and immunotherapy strategies.<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/82568","type":"journal-article","created":{"date-parts":[[2026,4,16]],"date-time":"2026-04-16T19:12:20Z","timestamp":1776366740000},"page":"e82568-e82568","source":"Crossref","is-referenced-by-count":0,"title":["Assessment of Programmed Cell Death Ligand-1 Expression in Oral Potentially Malignant Disorders and Tumor-Free Surgical Margins of Oral Squamous Cell Carcinoma: Protocol for a Retrospective Cross-Sectional Study"],"prefix":"10.2196","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9225-7919","authenticated-orcid":false,"given":"Archana","family":"Sonone","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8576-7897","authenticated-orcid":false,"given":"Alka","family":"Hande","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9278-5786","authenticated-orcid":false,"given":"Swati","family":"Patil","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0529-3856","authenticated-orcid":false,"given":"Aayushi","family":"Pakhale","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9942-5647","authenticated-orcid":false,"given":"Preethi","family":"Sharma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2026,4,16]]},"reference":[{"key":"R1","doi-asserted-by":"publisher","DOI":"10.1155\/2020\/1634252","article-title":"The LncRNA H19 rs217727 polymorphism is associated with oral squamous cell carcinoma susceptibility in Iranian population","volume":"2020","author":"Ghapanchi","journal-title":"Biomed Res Int"},{"issue":"3","key":"R2","doi-asserted-by":"publisher","first-page":"209","DOI":"10.3322\/caac.21660","article-title":"Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries","volume":"71","author":"Sung","journal-title":"CA Cancer J Clin"},{"issue":"3","key":"R3","doi-asserted-by":"publisher","first-page":"180","DOI":"10.18231\/j.achr.2023.040","article-title":"Assessment of programmed cell death ligand-1 (PD-L1) expression in oral potentially malignant disorders and oral squamous cell carcinoma - an immunohistochemical study","volume":"8","author":"Pachpande","journal-title":"IP Arch Cytol Histopathol Res"},{"issue":"7","key":"R4","doi-asserted-by":"publisher","first-page":"485","DOI":"10.1016\/j.oraloncology.2010.01.019","article-title":"Molecular analysis of surgical margins in head and neck cancer: more than a marginal issue","volume":"46","author":"Braakhuis","journal-title":"Oral Oncol"},{"issue":"6","key":"R5","doi-asserted-by":"publisher","first-page":"574","DOI":"10.1016\/j.pathol.2016.07.003","article-title":"Programmed cell death-ligand 1 expression in oral squamous cell carcinoma is associated with an inflammatory phenotype","volume":"48","author":"Satgunaseelan","journal-title":"Pathology"},{"issue":"6","key":"R6","doi-asserted-by":"publisher","first-page":"09","DOI":"10.31782\/IJCRR.2020.12062","article-title":"Role of immunohistochemical markers in surgical margins of patients with head and neck carcinoma \u2013 a systematic review","volume":"12","author":"Ranka","journal-title":"Int J Curr Res Rev"},{"key":"R7","doi-asserted-by":"publisher","DOI":"10.1016\/j.critrevonc.2020.102948","article-title":"Systematic review: soluble immunological biomarkers in advanced non-small-cell lung cancer (NSCLC)","volume":"153","author":"Mildner","journal-title":"Crit Rev Oncol Hematol"},{"issue":"4","key":"R8","doi-asserted-by":"publisher","first-page":"252","DOI":"10.1038\/nrc3239","article-title":"The blockade of immune checkpoints in cancer immunotherapy","volume":"12","author":"Pardoll","journal-title":"Nat Rev Cancer"},{"key":"R9","doi-asserted-by":"publisher","DOI":"10.1038\/s41422-020-0343-4","article-title":"Immune checkpoint signaling and cancer immunotherapy","volume":"30","author":"He","journal-title":"Cell Res"},{"issue":"1","key":"R10","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-020-66257-6","article-title":"Increased expression of PD-1 and PD-L1 in oral lesions progressing to oral squamous cell carcinoma: a pilot study","volume":"10","author":"Dave","journal-title":"Sci Rep"},{"issue":"15_suppl","key":"R11","doi-asserted-by":"publisher","first-page":"3016","DOI":"10.1200\/jco.2013.31.15_suppl.3016","article-title":"Association of tumor PD-L1 expression and immune biomarkers with clinical activity in patients (pts) with advanced solid tumors treated with nivolumab (anti-PD-1; BMS-936558; ONO-4538)","volume":"31","author":"Grosso","journal-title":"J Clin Oncol"},{"issue":"10","key":"R12","doi-asserted-by":"publisher","first-page":"3018","DOI":"10.1002\/hed.26339","article-title":"Prevalence of PD-L1 expression in head and neck squamous precancerous lesions: a systematic review and meta-analysis","volume":"42","author":"Girolami","journal-title":"Head Neck"},{"issue":"32","key":"R13","doi-asserted-by":"publisher","first-page":"3838","DOI":"10.1200\/JCO.2016.68.1478","article-title":"Antitumor activity of pembrolizumab in biomarker-unselected patients with recurrent and\/or metastatic head and neck squamous cell carcinoma: results from the phase Ib KEYNOTE-012 expansion cohort","volume":"34","author":"Chow","journal-title":"J Clin Oncol"},{"issue":"14","key":"R14","doi-asserted-by":"publisher","first-page":"1723","DOI":"10.7150\/ijms.27860","article-title":"Significance of PD-L1 expression in tongue cancer development","volume":"15","author":"Yoshida","journal-title":"Int J Med Sci"},{"issue":"4","key":"R15","doi-asserted-by":"publisher","first-page":"573","DOI":"10.1111\/his.13646","article-title":"PD-1 and PD-L1 expression in HNSCC primary cancer and related lymph node metastasis - impact on clinical outcome","volume":"73","author":"Schneider","journal-title":"Histopathology"},{"issue":"1","key":"R16","doi-asserted-by":"publisher","DOI":"10.1186\/s13000-018-0689-9","article-title":"PD-L1 diagnostic tests: a systematic literature review of scoring algorithms and test-validation metrics","volume":"13","author":"Udall","journal-title":"Diagn Pathol"},{"issue":"6","key":"R17","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.85186","article-title":"Evaluation of programmed death-ligand 1 (PD-L1) expression and its correlation with clinicopathological parameters in oral squamous cell carcinoma: a tertiary care center study","volume":"17","author":"Srivastava","journal-title":"Cureus"},{"issue":"2","key":"R18","first-page":"265","volume":"24","author":"Roncella","journal-title":"J Exp Clin Cancer Res"},{"issue":"2","key":"R19","doi-asserted-by":"publisher","DOI":"10.3390\/jpm13020363","article-title":"Effect of radio-chemotherapy on PD-L1 immunohistochemical expression in head and neck squamous cell carcinoma","volume":"13","author":"Girolami","journal-title":"J Pers Med"},{"issue":"1","key":"R20","doi-asserted-by":"publisher","DOI":"10.1186\/s40902-019-0239-8","article-title":"PD-L1 expression correlated with p53 expression in oral squamous cell carcinoma","volume":"41","author":"Tojyo","journal-title":"Maxillofac Plast Reconstr Surg"},{"issue":"6","key":"R21","doi-asserted-by":"publisher","first-page":"631","DOI":"10.1016\/j.oooo.2019.07.008","article-title":"Association of PD-L1 expression in oral squamous cell carcinoma with smoking, sex, and p53 expression","volume":"128","author":"Ahmadi","journal-title":"Oral Surg Oral Med Oral Pathol Oral Radiol"},{"issue":"6","key":"R22","doi-asserted-by":"publisher","DOI":"10.21037\/atm.2020.02.96","article-title":"Response to nivolumab combining radiotherapy and nimotuzumab in metastatic oral squamous cell carcinoma patient with strong PD-L1 expression: a case report","volume":"8","author":"Tang","journal-title":"Ann Transl Med"},{"key":"R23","doi-asserted-by":"publisher","DOI":"10.12659\/MSM.912632","article-title":"Association between activation of the programmed cell death-1 (PD-1)\/programmed death-ligand 1 (PD-L1) pathway and pain in patients with cancer","volume":"25","author":"Zhang","journal-title":"Med Sci Monit"}],"container-title":["JMIR Research Protocols"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.researchprotocols.org\/2026\/1\/e82568","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T18:16:33Z","timestamp":1782843393000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.researchprotocols.org\/2026\/1\/e82568"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4,16]]},"references-count":23,"URL":"https:\/\/doi.org\/10.2196\/82568","relation":{},"ISSN":["1929-0748"],"issn-type":[{"value":"1929-0748","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4,16]]},"article-number":"v15i3e82568"}}