suPAR is a Potential Biomarker of in Chronic Periodontitis Through the Impact of Post-radiotherapy on HNCs Patients (HNCs)

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

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).

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Chronic Periodontitis; Radiotherapy; Complications
• Intervention / Treatment: Radiation: Head and Neck cancer post-radiotherapy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Iraq
  • Anbar
    • Ramadi, Anbar, Iraq, 31001
      • Ahmed A. Al-Kubaisi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• A pathologically confirmed malignant neoplasm of HNC (derived from epithelial cells).
• Not having received radiation therapy previously.
• No distant metastasis.
• No history of salivary gland surgery (parotid, submandibular, or sublingual).
• 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.

Exclusion Criteria:

• Previous oral disease or salivary gland disease history.
• Definitive diagnosis of multiple sclerosis, xerostomia, or systemic disease.
• Refusal to participate in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Head and neck cancer post-radiotherapy; 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)].	Radiation: Head and Neck cancer post-radiotherapy; Head and Neck Cancer patients who received radiotherapy after 6 months; Other Names: Head and neck cancer patients after 6 irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of serum suPAR level	Measure of serum suPAR level in patients head and neck cancer who received radiotherapy	at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal parameters measured	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.	at 6 month

Collaborators and Investigators

• Sponsor: Al-Maarif University College
• Investigators: Study Director: Ahmed A. Al-Kubaisi, PhD, Al-Maarif University College; Study Chair: Maysam A. Ghazi, MSc, Al-Maarif University College; Study Chair: Nisreen S. Majeed, MSc, Al-Maarif University College; Study Chair: Ekram R. Aldelaimi, BDS, Department of Periodontology, Al-Anbar Health Directorate, Ministry of Health; Study Director: Hamid H. Enezei, PhD, Department of Oral and Maxillofacial Surgery, College of Dentistry, University of Anbar

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): January 9, 2023
• Study Completion (Actual): June 23, 2023

Study Registration Dates

• First Submitted: June 22, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Chronic Disease; Head and Neck Neoplasms; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: suPAR as a biomarker

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No