Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT06481059
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2024-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
suPAR is a Potential Biomarker of in Chronic Periodontitis Through the Impact of Post-radiotherapy on HNCs Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D055113', 'term': 'Chronic Periodontitis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2024-06-22', 'studyFirstSubmitQcDate': '2024-06-27', 'lastUpdatePostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of serum suPAR level', 'timeFrame': 'at 6 months', 'description': 'Measure of serum suPAR level in patients head and neck cancer who received radiotherapy'}], 'secondaryOutcomes': [{'measure': 'Periodontal parameters measured', 'timeFrame': 'at 6 month', 'description': 'All periodontal parameters (Clinical attachment level, Gingival bleeding Index, Plaque index, and Periodontal pocket depth measures were performed manually using a millimeter periodontal probe in patients who received radiotherapy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer', 'Chronic Periodontitis', 'Radiotherapy; Complications']}, 'referencesModule': {'references': [{'pmid': '33340075', 'type': 'RESULT', 'citation': 'Gasparoni LM, Alves FA, Holzhausen M, Pannuti CM, Serpa MS. Periodontitis as a risk factor for head and neck cancer. Med Oral Patol Oral Cir Bucal. 2021 Jul 1;26(4):e430-e436. doi: 10.4317/medoral.24270.'}, {'pmid': '35304084', 'type': 'RESULT', 'citation': 'Lalla RV, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Helgeson ES, Lin A, Rybczyk C, Dowsett R, Hegde U, Boyd TS, Duplinsky TG, Brennan MT. Radiation therapy for head and neck cancer leads to gingival recession associated with dental caries. Oral Surg Oral Med Oral Pathol Oral Radiol. 2022 May;133(5):539-546. doi: 10.1016/j.oooo.2022.01.016. Epub 2022 Jan 31.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to improve a soluble urokinase plasminogen activator receptor suPAR is a reliable biomarker of chronic periodontitis and may be replaced in patients with head and neck cancer post-radiotherapy (HNC post-RT).', 'detailedDescription': 'The urokinase-type plasminogen activator receptor (uPAR) plays an essential function in leukocytes and endothelial homeostasis and, therefore, in the development of chronic periodontitis. The study enrolled 150 participants, 50 chronic periodontitis with head and neck cancer post radiotherapy (CP+HNC post-RT) patients, 50 chronic periodontitis (CP) without HNC patients, and 50 healthy controls. Clinical Attachment Loss (CAL), Probing Pocket Depth (PPD), Plaque Index (PI), and Gingival Bleeding Index (GBI) were recorded. An enzyme-linked immunosorbent assay (ELISA) was constructed to quantify serum (suPAR) levels. Stage and grade of periodontitis were stage III-IV, grade C in patients (CP+HNC post-RT), stage I-III, grade A/B in patients (CP without HNC), and absent in (healthy). Chronic periodontitis with HNC post-RT patients presented a significantly higher proportion of suPAR levels (506.7 pg/ml) compared to chronic periodontitis without HNC and healthy controls (423.08 pg/ml and 255.9 pg/ml), respectively. A significant positive correlation was found between serum suPAR levels and CAL, PPD, PI, and GBI in the periodontal disease groups. ROC results of suPAR (AUC=0.976 for CP+HNC post-RT, AUC=0.872 for CP without HNC). Hyposalivation appeared in patients (CP+HNC post-RT; 0.15 \\[0.11-0.23\\] ml/min, P=0.001) and (CP without HNC; 0.30 \\[0.25-0.41\\] ml/min, P=0.001), compared to healthy controls; 0.35 \\[0.28- 0.54\\] ml/min, P=0.001). The study showed a significant elevation in serum suPAR levels in CP+HNC post-RT patients compared to the CP without HNC and control groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '28 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study was n=26 nasopharyngeal tumors (n=20 nonkeratinizing and n=6 keratinizing carcinomas), (n=6 oropharyngeal squamous cell carcinoma, SCC), (n=8 Laryngeal cancer), (n=6 tongue cancer), and (n=4 primary malignancies of unclear origin). Many patients had a history of smoking, and the mean patient age was 45.8 years (min-max: 28-72 years); 40 (80%) were men. Twenty-eight of the patients (or 56%) had a concomitant systemic therapy (2-3 doses) of cisplatin or cetuximab in addition to radiotherapy. Chronic periodontitis patients (n=50) without HNCs. More than half of them had a history of smoking, with 31 (62%) and 5 (10) of them having used alcohol. A control group (n=50) was used periodontally healthy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A pathologically confirmed malignant neoplasm of HNC (derived from epithelial cells).\n* Not having received radiation therapy previously.\n* No distant metastasis.\n* No history of salivary gland surgery (parotid, submandibular, or sublingual).\n* A generally satisfactory physical condition with a performance score of 0 to 1 point and a planned survival period of more than a year and scores of 2 higher indicating increasing disability.\n\nExclusion Criteria:\n\n* Previous oral disease or salivary gland disease history.\n* Definitive diagnosis of multiple sclerosis, xerostomia, or systemic disease.\n* Refusal to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06481059', 'acronym': 'HNCs', 'briefTitle': 'suPAR is a Potential Biomarker of in Chronic Periodontitis Through the Impact of Post-radiotherapy on HNCs Patients', 'organization': {'class': 'OTHER', 'fullName': 'Al-Maarif University College'}, 'officialTitle': 'Soluble Urokinase Plasminogen Activator Receptor (suPAR) is a Potential Biomarker of Stage III-IV, Grade C Periodontitis Through the Impact of Post-radiotherapy on Head and Neck Cancer Patients', 'orgStudyIdInfo': {'id': 'suPAR as a biomarker'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Head and neck cancer post-radiotherapy', 'description': 'Head and neck cancer patients who received radiotherapy after six months. fractions no. \\[(32-35 fractions) 5700-7000 Gy\\] addition chemotherapy \\[(cisplatin or cetuximab) (2-3 doses)\\].', 'interventionNames': ['Radiation: Head and Neck cancer post-radiotherapy']}], 'interventions': [{'name': 'Head and Neck cancer post-radiotherapy', 'type': 'RADIATION', 'otherNames': ['Head and neck cancer patients after 6 irradiation'], 'description': 'Head and Neck Cancer patients who received radiotherapy after 6 months', 'armGroupLabels': ['Head and neck cancer post-radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31001', 'city': 'Ramadi', 'state': 'Al Anbar', 'country': 'Iraq', 'facility': 'Ahmed A. Al-Kubaisi', 'geoPoint': {'lat': 33.42056, 'lon': 43.30778}}], 'overallOfficials': [{'name': 'Ahmed A. Al-Kubaisi, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Al-Maarif University College'}, {'name': 'Maysam A. Ghazi, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Al-Maarif University College'}, {'name': 'Nisreen S. Majeed, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Al-Maarif University College'}, {'name': 'Ekram R. Aldelaimi, BDS', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Periodontology, Al-Anbar Health Directorate, Ministry of Health'}, {'name': 'Hamid H. Enezei, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Oral and Maxillofacial Surgery, College of Dentistry, University of Anbar'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Maarif University College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}