Skip to main content
OpenTrials
Completed

NCT Number: NCT06481059

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

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Head and Neck cancer post-radiotherapy

Radiation

Head and Neck Cancer patients who received radiotherapy after 6 months

Other names: Head and neck cancer patients after 6 irradiation

Primary outcomes

  1. Measure of serum suPAR level

    Time frame: at 6 months

    Measure of serum suPAR level in patients head and neck cancer who received radiotherapy

Secondary outcomes

  1. Periodontal parameters measured

    Time frame: at 6 month

    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.

Sponsors and collaborators

Lead sponsor

Al-Maarif University College

Other

Registry information

Official study title

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

Acronym: HNCs

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 1, 2024
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.