[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oral-leukoplakia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oral-leukoplakia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,50,83,108,130,156,189,218],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100583416","phase-2-low-cost-screening-and-image-guided-photodynamic-therapy-pdt-of-premalignant-and-malignant-oral-lesions-100583416",false,"NCT06876038","Low-cost Screening and Image-guided Photodynamic Therapy (PDT) of Premalignant and Malignant Oral Lesions","A Comprehensive Platform for Low-cost Screening and Image-guided Photodynamic Therapy (PDT) Treatment of Pre-malignant and Malignant Oral Lesions in Low-resource Setting","Subject Inclusion Criteria\n\n1. One grossly visible OPML, with histopathologically confirmed diagnosis of moderate, severe, and carcinoma in situ measuring ≥ 10 mm in diameter.\n2. Willing and available for follow-up for at least one year and at prerequisite time intervals.\n3. All patients above the age of 18 years and willing to voluntarily give a signed informed consent.\n4. Karnofsky Performance Score above 80 or ECOG 0 or 1.\n5. The subjects meeting the following laboratory eligibility criteria during a time not older than 2 months before accrual\n\n   * Hemoglobin level above or equal to 10%\n   * WBC \\>3000\u002Fmm3\n   * Platelets count \\>100000\u002Fmm3\n   * Total bilirubin, AST (SGOT), ALT (SGPT) \\\u003C 1.5 times the Upper Limit Normal\n   * eGFR \\> 60 ml\u002Fmin\n   * Serum Creatine less than 2 times the Upper Limit of laboratory normal\n   * INR\u002F PT and PTT within laboratory normal limits\n\nExclusion criteria:\n\n1. Hypersensitivity against active substances and porphyrins.\n2. Known diagnosis of porphyria.\n3. Simultaneous use of other potentially phototoxic substances (eg; tetracyclines, sulphonamides, fluoroquinolones, hypericin extracts).\n4. Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled cardiac and renal diseases or psychiatric illness.\n5. Subjects with inherited or acquired bleeding and clotting disorders\n6. Women who are breastfeeding\u002F have a positive urine pregnancy test or are planning their family.\n7. Patients who have taken supplements of retinol, beta carotene, vitamin E, Selenium, or other chemo-preventive therapy at least one month prior to the baseline visit.\n8. Patients with histological evidence of no dysplasia, mild dysplasia, invasive carcinoma, and any active malignant disease.\n9. Patients with behavioral and cognitive impairment.\n10. Patients who are concurrently diagnosed and undergoing treatment for other head and neck cancers.\n11. Patients with large lesions, which, in the investigator's opinion, may require reconstructive surgery after excision.\n12. The subjects, in the opinion of the Institutional Principal Investigator, are not an appropriate candidate for study participation due to alcoholism and abstinence.\n13. Patient who was in a clinical trial for 4 weeks before participation in the present trial.","ALL","18 Years","65 Years",{"count":20,"type":21},65,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The primary goal of this study is to see if photodynamic therapy (PDT) is effective for treatment of lesions in the oral cavity which have high risk of becoming oral cancer. PDT treatment uses a drug, called a photosensitizer, which makes the diseased cells become light-sensitive such that they are destroyed when laser light is delivered to the target lesion. In this study a new handheld device, called SITOS (a \"Screen, Image and Treat Optical System), is used. The ability of this device to simultaneously visualize the inside of the mouth and deliver laser light to the target site will be evaluated. The main questions this study seeks to answer are:\n\n* Can this treatment completely cure oral potentially malignant lesions (OPML) without need for surgery?\n* Do lesions recur after PDT treatment?\n* Is the SITOS device easy to use for the doctor and comfortable for the patient, both as an oral imaging device and as a treatment device?",[27,28,29,30,31],"Oral Cancer","Oral Cavity Cancer","Oral Leukoplakia","Oral Lichen Planus","Oral Squamous Cell Carcinoma",[33,34,35,36],"High grade dysplasia (HGD)","Severe\u002FModerate dysplasia","Carcinoma-in-situ (CIS)","Oral potentially malignant lesion (OPML)","NOT_YET_RECRUITING","2026-03-16",{"date":40,"type":41},"2026-03-19","ACTUAL",{"date":43,"type":21},"2026-09",{"date":45,"type":21},"2028-12",{"name":47,"class":48},"University of Massachusetts, Boston","OTHER",2,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100627810","phase-3-comparison-of-topical-photodynamic-therapy-with-topical-calcipotriol-in-management-of-oral-leukoplakia-100627810","NCT07453472","Comparison of Topical Photodynamic Therapy With Topical Calcipotriol in Management of Oral Leukoplakia","Comparative Evaluation of the Effect of Topical Photodynamic Therapy Versus Topical Calcipotriol on the Clinical and Molecular Characteristics of Oral Leukoplakia: a Randomized Clinical Trial","PDT CALCI HOL","Inclusion Criteria:\n\n* All diagnosed cases of Oral Leukoplakia with size ≥ 2 cm2 (Van der Waal classification ≥ L2) reporting to the department of OMR, CDER and willing to participate in the study will be included\n* Subjects clinically and histologically diagnosed as Oral Leukoplakia.\n* Subjects \\> 18 years of age.\n* Subjects willing to participate in the study and to complete the treatment sessions.\n\nExclusion Criteria:\n\n* History of any topical and\u002For systemic therapy for Oral Leukoplakia other than general management in last 2 months.\n* Subjects with current or past history of malignancy.\n* Subjects with any lesion suspicious of malignancy requiring biopsy.\n* Subjects with severe dysplasia and carcinoma in situ on biopsy of oral lesion\n* Subjects with history of hyperphotosensitivity (genetic disorders, dermatological conditions, drug induced, systemic conditions)\n* Subjects with calcium, Vit D metabolic and parathyroid disorders\n* Pregnant and lactating females.","99 Years",{"count":60,"type":21},166,[62],"PHASE3","(i)Rationale\u002F gaps in existing knowledge,: Oral cancer, one of the top three common cancers in India is usually preceded by Oral potentially malignant disorders in nearly two thirds of the cases like Oral leukoplakia. OL has a high prevalence and malignant transformation rates(0.13% - 40.8%). There are no universal protocols for management in OL ranging from preventive, conservative, medical and surgical interventions. They all have limitations and high recurrence rates requiring regular follow up.\n\n(ii)Novelty: Removal of pathological lesions are believed to reduce the risk of malignant transformation in OL. Surgical methods are associated with morbidity and high recurrence rates. Non -invasive methods (like Photodynamic therapy) that can remove the abnormal lesions would be preferred as they are cheaper, convenient, safe with less morbidity and better patient acceptability. They also have the advantage of repeatability with minimum morbidity and damage to adjacent normal tissues. Non -invasive medical management involves topical application of retinoids which are associated with systemic toxicity, recurrence and development of resistance.\n\n(iii)Objectives,\n\nPrimary objective:\n\nTo compare the effect of 2.5% Toluidine blue mediated topical photodynamic therapy and topical calcipotriol (0.005%) on clinical response after completion of treatment at 4 weeks from baseline during management of Oral leukoplakia\n\nSecondary objectives:\n\nTo compare the effect of 2.5% Toluidine blue mediated topical photodynamic therapy with topical Calcipotriol (0.005%) on lesion size, lesion roughness\u002F whiteness, and oral health quality of life after completion of treatment at 4 weeks and 12 weeks from baseline during management of Oral leukoplakia To compare the effect of 2.5% Toluidine blue mediated topical photodynamic therapy with topical Calcipotriol (0.005%) on salivary molecular markers ( IL6, TNF-α, PCNA, Survivin and VEGF) after completion of treatment at 4 weeks from baseline To compare the adverse events, time to complete response and recurrence rates between the two groups\n\n(iv)Methods,: An open label randomized clinical trial where Group A (n=83) will receive 4 sessions of Toludine blue mediated photodynamic therapy (Fluence 15J\u002Fcm2); GroupB (n=83) will receive twice daily tropical application of Calcipotriol (0.005%) over a period of 4 weeks. The clinical response, lesion thickness\u002F whiteness, lesion size \u002Farea, OHIP-14 scores, adverse events and recurrence rates will be compared with baseline at 4 weeks and 12 weeks after completion of therapy. Sterile PVA ophthalmic sponges will be used to evaluate molecular markers ( IL6, TNF-α, PCNA, Survivin VEGF) from treatment site of lesion at baseline and 4 weeks after completion of treatment by ELISA. The data will be analyzed statistically using Intention to treat and as per protocol analysis at significance levels of p\\\u003C0.05.\n\n(v)Expected outcome.: The study will validate and verify the effectiveness of the TB mediated PDT protocol in the management of OL as compared to other non invasive method of topical Calcipotriol in terms of clinical response ( complete\u002F partial\u002F none), lesion thickness\u002F whiteness, lesion size and it's effect on oral health quality of life. Adverse events if any and recurrence rates or malignant transformation rates will also help in assessment of safety of the protocol. The molecular markers will help to monitor and determine prognosis of the lessons following treatment.",[29],[66,67,68,69,70,71,72],"Oral leukoplakia","photodynamic therapy","photosensitizers","calcipotriol","assessment","patient outcomes","biology molecular","2026-02-27",{"date":75,"type":41},"2026-03-06",{"date":77,"type":21},"2026-04",{"date":79,"type":21},"2029-03",{"name":81,"class":48},"Dr. Shalini Gupta",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":90,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":96,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":82},"100622767","phase-2-evaluation-of-the-chemo-preventive-effect-of-combined-topical-and-systemic-metformin-on-oral-leukoplakia-100622767","NCT07387900","Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia","Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Adult patients over 21 years.\n* Patients clinically diagnosed and histologically confirmed as having oral Leukoplakia.\n* Lesions with mild to moderate degree of dysplasia.\n* Patients who agree to sign a written consent after understanding the nature of the study.\n\nExclusion Criteria:\n\n* Patients with lesions showing sever degree of dysplasia.\n* Patients who have cardiovascular, lung, Renal, Liver diseases\n* Patients on metformin therapy (eg: Diabetes Mellitus, PCOS, …etc.)\n* Patients on H2 blocker \\& proton pump inhibitors therapy as Ranitidine (affects metformin absorption and clearance)\n* Those with allergy or sensitivity to Metformin therapy or having any contraindication for their use.\n* Patients on Retinoid, green tea supplements or another natural products therapy\n* Patients with other accompanying oral lesions\n* Pregnant or Lactating females","21 Years",{"count":92,"type":21},34,[24],"There is no consensus on treatment of leukoplakia but surgical excision is the preferred choice if suitable in size, which does not prevent clinical recurrence and malignant transformation. Chemoprevention is a new direction in the management of OL using various topical and systemic agents such as; vitamin A, lycopene, celecoxib, green tea extract, and metformin.\n\nWhile metformin cannot realistically be used as cancer mono-therapy, it can be used as an adjunct and can have a more promising effect on lesions that have yet to undergo malignant transformation. Thus, the aim of this study is to investigate the efficacy of combined chemo-preventive effect of topical and systemic Metformin on oral leukoplakia.",[29],[29,97],"Metformin","RECRUITING","2026-02-04",{"date":101,"type":41},"2026-02-06",{"date":103,"type":21},"2026-02",{"date":105,"type":21},"2027-10",{"name":107,"class":48},"Cairo University",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":115,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":82},"100618462","efficacy-of-topical-coenzyme-q10-and-curcumin-for-oral-leukoplakia-treatment-100618462","NCT07331935","Efficacy of Topical Coenzyme Q10 and Curcumin for Oral Leukoplakia Treatment","Clinical and Biochemical Assessment of the Effectivness of Topical Coenzyme Q10 and Topical Curcumin in Managment of Oral Leukoplakia (A Randomized Controlled Clinical Trial)","Inclusion Criteria:\n\n* Clinically and histologically diagnosed with homogeneous oral leukoplakia not indicated for surgical excision .\n* Lesions accessible for topical application.\n* Willing to sign informed consent and comply with study instructions and return to follow up\n\nExclusion Criteria:\n\n* Moderate-to-severe dysplasia, carcinoma in situ, or invasive oral cancer.\n* Presence of any visible oral lesions except for oral leukoplakia.\n* Active periodontal diseases as this can confound salivary biomarkers.\n* Significant systemic illness or immunosuppression.\n* Patients who have taken systemic or topical antioxidant supplements within the last four weeks will be excluded to avoid confounding effects on salivary biomarkers.\n* Pregnant and lactating women will be excluded due to hormonal changes that may alter oxidative stress and ethical considerations.\n* Patients unwilling or unable to comply with study requirements.","40 Years",{"count":92,"type":21},[118],"NA","Oral leukoplakia (OL) is recognized as the most common potentially malignant disorder of the oral mucosa. The pathogenesis of OL is complex and multifactorial, with oxidative stress playing a central role. Topical antioxidants have gained attention as therapeutic options to help stabilize lesions and potentially prevent malignant transformation. Both CoQ10 and curcumin have demonstrated a clinical success as strong antioxidants showing their capacity to reduce the lesion size and to stabilize the disease, ultimately preventing progression into oral malignancy. Aim: This study aims to clinically and biochemically assess the effectiveness of topical Coenzyme Q10 and Curcumin in the management of homogeneous oral leukoplakia.",[29],"2025-12-27",{"date":123,"type":41},"2026-01-12",{"date":125,"type":41},"2025-11-25",{"date":127,"type":21},"2026-03-30",{"name":129,"class":48},"Alexandria University",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":49},"100495175","phase-2-pioglitazone-metformin-combination-treatment-for-high-risk-oral-preneoplasia-100495175","NCT05727761","Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia","Inclusion Criteria:\n\n* Biopsy proven hyperplasia in high risk anatomic areas (floor of mouth, mobile tongue, oropharynx). Hyperplasia or dysplasia of any grade in any erythroplakia lesion. Mild, moderate or severe dysplasia within the lesion at any site of the oral cavity or oropharynx.\n* Must have objective evidence of oral leukoplakia that is measurable in 2 dimensions per RECIST. The lesion(s) may be clinically characterized by leukoplakia, erythroplakia, erythro\u002Fleukoplakia. Lesions may be located in the oral cavity or oropharynx. However, the index lesion must be located in an anatomic site accessible by punch biopsy and be a minimum of 4mm x 8 mm to permit a 4mm punch biopsy.\n* Age 18 years or older at the time of consent.\n* Evidence of adequate organ function within 14 days prior to Day 1\n* Able to comply with treatment (i.e. able to swallow a tablet whole, not crushed) and complete a 12 week course of twice daily medication as required by this study in the opinion of the treating investigator.\n* Body mass index (BMI) is ≥ 18.5.\n* Sexually active persons of child-bearing potential agrees to use adequate contraception (a hormonal method that has been in continual use for a minimum of 3 months prior to the study screening visit, a barrier method, or abstinence) for the duration of study participation.\n* Provides voluntary written consent prior to the performance of any research related activity.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding or planning to become pregnant.\n* A concurrent diagnosis of Type I or Type II diabetes that is being treated with insulin or an antidiabetic agent. Participants whose Type II diabetes is controlled with diet and\u002For exercise alone are eligible provided they meet all other eligibility criteria.\n* Participant is taking another investigational agent (not approved by the FDA for any indication).\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ACTOplus Met, pioglitazone or metformin.\n* Any contraindication to biopsy - this study requires a 4 mm punch biopsy of a lesion and of nearby normal tissue prior to treatment and at the end of the 12 week treatment period.\n* History of bladder cancer, including in situ bladder cancer.\n* History of invasive cancer (other than non-melanoma skin cancer or cervical cancer in situ) active within 18 months prior to the baseline study visit. (Participants who have a history of cancer that was curatively treated without evidence of recurrence in the 18 months prior to the baseline study visit are considered eligible).",{"count":137,"type":21},36,[24],"This is a Phase IIa oral cavity leukoplakia study of pioglitazone 15mg and metformin 500mg BID for 12 weeks. The primary objective is to determine the clinical and histologic changes of leukoplakia from baseline following a 12 week course of twice daily pioglitazone-metformin. Outcomes are defined as are a reduction of the leukoplakia grade in \\> 50% of treated participants and a partial or complete clinical response defined as 50% or greater reduction in the sum of measured targeted lesions. In addition, participants who show clinical and histologic improvement should correlate with a significant reduction of Ki-67 proliferative indices in lesions of these participants as compared to baseline.",[29],[142,143,144,145,146],"oral leukoplakia","oral cancer prevention","pioglitazone","metformin","precancerous oral lesion","2025-12-22",{"date":149,"type":41},"2025-12-24",{"date":151,"type":41},"2025-01-01",{"date":153,"type":21},"2026-07-28",{"name":155,"class":48},"University of Minnesota",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":163,"maxAge":164,"enrollmentInfo":165,"targetDuration":4,"studyType":167,"phases":4,"briefSummary":168,"conditions":169,"keywords":172,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":4},"100617461","evaluation-of-artificial-intelligence-in-diagnosis-and-risk-assessment-of-oral-potentially-malignant-disorders-100617461","NCT07318922","Evaluation of Artificial Intelligence in Diagnosis and Risk Assessment of Oral Potentially Malignant Disorders","Evaluation of Artificial Intelligence in Diagnosis and Risk Assessment of Oral Potentially Malignant Disorders Using Clinical and Exfoliative Cytology Imaging","Inclusion Criteria:\n\n1- Patients have no signs of super infection of candida on the lesions. 2- A lesion with a provisional clinical diagnosis of (OLP, OLK, OEP, non-healing ulcers) at any site in the oral cavity (buccal mucosa, hard palate, labial mucosa, tongue, gingiva).\n\n\\-\n\nExclusion Criteria:\n\n* Any other mucosal lesions.","30 Years","75 Years",{"count":166,"type":21},120,"OBSERVATIONAL","Oral potentially malignant disorders (OPMDs) are mucosal lesions that carry a risk of malignant transformation into oral cancer. Unfortunately, a general lack of knowledge and awareness of OPMDs is common among general dental practitioners. While thorough clinical examinations coupled with biopsy can identify most OPMDs, the absence of reliable non-invasive diagnostic tools and standardized risk stratification often delays early diagnosis and treatment of oral squamous cell carcinoma (OSCC).Early detection of suspicious oral lesions is crucial for reducing OSCC-related mortality and improving patient outcomes. Histopathological assessment of biopsied tissue remains the gold standard for diagnosis. However, since biopsy is invasive and may be associated with patient discomfort; numerous noninvasive diagnostic technologies have emerged to enhance the detection and diagnosis of oral mucosal lesions.Toluidine blue (TB) staining is one such adjunctive tool, where the degree of color retention aids in lesion characterization. Dark blue staining is considered positive for lesions highly suspicious for malignancy; light blue retention is considered positive for premalignant lesions pending histopathological confirmation, while lesions showing no stain retention are classified as negative.Exfoliative cytology represents another non-invasive diagnostic approach, wherein cells obtained via brushing the oral mucosa are spread on a slide for cytological evaluation. This technique, widely accepted and increasingly utilized, has proven valuable for early cancer detection. Notably, confocal microscopy has demonstrated high sensitivity and specificity (93%) in detecting malignant cells in exfoliative cytology specimens. Currently, TB staining and confocal microscopy remain the most commonly utilized non-invasive screening techniques in clinical practice.In recent years, artificial intelligence (AI) applications have shown remarkable promise in oncology, achieving high diagnostic accuracy across various cancer types. Deep learning models, in particular, offer exceptional performance, suggesting that AI-based solutions may be feasible for widespread community screening programs following further validation. In many cases, AI models have produced diagnostic outcomes that match or surpass those of experienced pathologists. Moreover, the combined application of AI with expert human evaluation has been shown to reduce diagnostic errors and improve diagnostic precision, particularly for poorly differentiated tumors and rare cases.Several studies have been done using different AI Models and revealed a promising application of AI in diagnosing OPMDs and cancers in different body sites.",[30,29,170,171],"Traumatic Ulcer of Oral Mucosa","Erythroleukoplakia of Mouth",[173,174,175,176,177,178,179],"OPMDs","Artificial Intelligence","Toluidine blue stain","Confocal microscope","Exfoliative Cytology","Acridine orange stain","Tissue biopsy","2025-12-20",{"date":182,"type":41},"2026-01-06",{"date":184,"type":21},"2025-12-16",{"date":186,"type":21},"2026-12-20",{"name":188,"class":48},"Ain Shams University",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":58,"enrollmentInfo":197,"targetDuration":4,"studyType":167,"phases":4,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":82},"100540758","systematical-trained-learning-algorithms-for-oral-carcinogenesis-interpretation-by-optical-coherence-tomography-100540758","NCT06321003","SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography","Single-blind Clinical Trial Assessing the Validity of Optical Coherence Tomography (OCT) in Diagnosing Potentially Malignant Oral Lesions and Oral Cancer","SYMILIS OCT","Inclusion Criteria:\n\n1. Adult patients with clinical suspicion of potentially malignant oral disorders (OPMDs) and oral squamous cell carcinoma (OSCC).\n2. Patients able to provide informed consent for participation in the study.\n3. Availability of complete clinical data and medical records.\n\nExclusion Criteria:\n\n1. Patients with a previous diagnosis of OSCC\u002FOPMDs and\u002For who have already undergone treatment.\n2. Patients with contraindications to the OCT examination for nonpermissive oral localization using the probe.\n3. Pregnant or breastfeeding women.\n4. Patients with disabilities, reluctance or difficulties of understanding to follow the procedures of the study and who have not provided a consent.",{"count":198,"type":21},200,"This clinical trial aims to assess the efficacy of Optical Coherence Tomography (OCT) in the early diagnosis of oral cancer. It focuses on Oral Potentially Malignant Disorders (OPMDs) as precursors to Oral Squamous Cell Carcinoma (OSCC). Despite the availability of oral screening, diagnostic delays persist, underscoring the importance of exploring non-invasive methodologies. The OCT technology provides cross-sectional analysis of biological tissues, enabling a detailed evaluation of ultrastructural oral mucosal features.\n\nThe trial aims to compare OCT preliminary evaluation with traditional histology, considered the gold standard in oral lesion diagnosing. It seeks to create a database of pathological OCT data, facilitating the non invasive identification of carcinogenic processes. The goal is to develop a diagnostic algorithm based on OCT, enhancing its ability to detect characteristic patterns such as the keratinized layer, squamous epithelium, basement membrane, and lamina propria in oral tissues affected by OPMDs and OSCC.\n\nFurthermore, the trial aims to implement Artificial Intelligence (AI) in OCT image analysis. The use of machine learning algorithms could contribute to a faster and more accurate assessment of images, aiding in early diagnosis. The trial aims to standardize the comparison between in vivo OCT images and histological analysis, adopting a site-specific approach in biopsies to improve correspondence between data collected by both methods.\n\nIn summary, the trial not only evaluates OCT as a diagnostic tool but also aims to integrate AI to develop a standardized approach that enhances the accuracy of oral cancer diagnosis, providing a significant contribution to clinical practice.",[31,201,29,202,30,203,204,205,206,207,27,208],"Oral Potentially Malignant Disorder","Proliferative Verrucous Leukoplakia","Oral Lichenoid Lesion","Graft-versus-host-disease","Oral Erythroplakia","Actinic Keratoses","Actinic Cheilitis","Oral Disease","2025-05-19",{"date":211,"type":41},"2025-05-23",{"date":213,"type":41},"2024-03-13",{"date":215,"type":21},"2028-04-01",{"name":217,"class":48},"University of Palermo",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":226,"enrollmentInfo":227,"targetDuration":229,"studyType":167,"phases":4,"briefSummary":230,"conditions":231,"keywords":234,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":82},"100360606","prediction-of-malignant-transformation-of-oral-leukoplakia-using-a-mage-a-based-immunoscore-100360606","NCT03975322","Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore","Prospective Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore","PREDICT-OLP","Inclusion Criteria:\n\n* Adults, consenting male or female patients\n* Age 18 - 80 years\n* Diagnosis of one or more leukoplakia of the oral cavity\n\nincluding\n\n* leukoplakia associated wit lichen planus OR\n* leukoplakia associated with diseases of the immune system or immunosuppression OR\n* leukoplakia associated with a malignoma of other sites (except oral cavity) in the anamnesis\n* Existing consent to participation in the study after clarification has been given\n\nExclusion Criteria:\n\n* clinical evidence of invasive carcinoma of the oral cavity OR\n* carcinoma of the oral cavity in the anamnesis OR\n* patients unable to give informed consent OR\n* rejection of the patient","80 Years",{"count":228,"type":21},500,"3 Years","Oral squamous cell carcinomas (OSCC) is among the most common malignancies worldwide. Early detection and prevention of OSCC is thought to have the highest potential to reduce morbidity and mortality. In prevention, the main focus is on precancerous lesions, especially oral leukoplakia (OLP), as up to 67% of OSCC arise on the basis of OLP. The determination of the transformation risk of OLP by histological determination of the degree of dysplasia is unreliable.\n\nA promising marker for the timely development of a OSCC is the detection of antigens of the MAGE-A gene family. The special feature of MAGE-A is that they can be detected in 93% of all OSCC and in approx. 85% of OLP that transform to OSCC. The detection of MAGE-A could also indicate changes in the immunological environment that occur prior to malignant OLP transformation and could be used for immunotherapies.\n\nAim of this study is to investigate MAGE-A as a predictive marker for the malignant transformation of OLP in the setting of a prospective, multicenter study and to establish it as a diagnostic parameter in addition to classical histology. In addition, the association of MAGE-A expression with the occurrence of immunological changes in OLP will be investigated in order to evaluate the possibility of minimally invasive immunotherapy of OLP.\n\nThe study is intended to include 500 biopsies of non-selected patients with OLP from university institutions and private practices. The follow-up should be at least 3 years, whereby it is examined whether an OSCC on the basis of the original OLP developed. After three years, an interim evaluation of the results with statistical evaluation will be carried out. In order to ensure that the course of the disease is monitored for at least three years for all OLPs, an extension of the monitoring period to 5 years is planned.\n\nThe study could establish a routine diagnostic parameter to supplement the histo-morphological diagnosis of OLP and evaluate the possibility of immunotherapy of OLP.",[29,232,233,30],"Oral Leukoplakia of Tongue","Oral Leukoplakia of Gingiva",[235,236,237,238],"OLP","oral cancer","OSCC","oral squamous cell carcinoma","2019-12-02",{"date":241,"type":41},"2019-12-03",{"date":243,"type":41},"2019-12-01",{"date":245,"type":21},"2026-12-30",{"name":247,"class":48},"University of Erlangen-Nürnberg Medical School"]