Clinical trial NCT06481059: suPAR is a Potential Biomarker of in Chronic Periodontitis Through the Impact of Post-radiotherapy on HNCs Patients
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Chronic Periodontitis
Radiotherapy; Complications
Lead sponsor: Al-Maarif University College
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 150
Sex: ALL
Minimum age (years): 28
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

Brief summary: 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measure of serum suPAR level
timeFrame: at 6 months
Secondary outcomes:
measure: Periodontal parameters measured
timeFrame: at 6 month
Other outcomes:
Locations:
city: Ramadi
country: Iraq
facility: Ahmed A. Al-Kubaisi
state: Anbar
Study officials:
affiliation: Al-Maarif University College
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: Department of Periodontology, Al-Anbar Health Directorate, Ministry of Health
name: Ekram R. Aldelaimi, BDS
role: STUDY_CHAIR
affiliation: Department of Oral and Maxillofacial Surgery, College of Dentistry, University of Anbar
name: Hamid H. Enezei, PhD
role: STUDY_DIRECTOR
References:
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.
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.