Estimation of (suPAR) in Chronic Periodontitis With 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 Side Effect
• Intervention / Treatment: Radiation: Radiation

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.

• 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). 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 without HNCs included: Patients' average ages ranged from 28 to 65 years, with 40 (80%) of them being male. More than half of them had a history of smoking, with 31 (62%) and 5 (10) of them having used alcohol. A control group was used periodontally healthy as a controlled study, the mean age was 40.12 years (min-max: 29-60 years).

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 (32-35 fractions) exposure (5700-7000 Gys) addition chemotherapy (cisplatin or cetuximab (2-3 dosages).	Radiation: Radiation; HNCs patients who received radiotherapy was exposure (5700-7000 Gys) for fractions number (32-35) 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	6 months
Clinical Periodontal parameters measured	Periodontal parameters included (CAL, PI, GBI, PPD) measured by using a millimeter periodontal probe in patients with head and neck cancer who received radiotherapy.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral pH-saliva was measured	Oral pH-saliva collected from outcomes and measured pH-saliva by using pH-meter in patients who underwent radiotherapy.	6 month

Collaborators and Investigators

• Sponsor: Al-Maarif University College
• Investigators: Study Director: Ahmed A. Al-Kubaisi, PhD, Al-Maarif University College

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Radiotherapy; Chronic Periodontitis
• 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 potential 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