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

NCT06481059 | Completed

• 1 other identifier: suPAR as a biomarker
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Head and Neck Cancer; Chronic Periodontitis; Radiotherapy; Complications

Outcome Measures

Primary Outcomes (1)

• Measure of serum suPAR level

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

  at 6 months

Secondary Outcomes (1)

• Periodontal parameters measured

  at 6 month

Study Arms (1)

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

Interventions

Head and Neck cancer post-radiotherapy RADIATION

Head and Neck Cancer patients who received radiotherapy after 6 months

Also known as: Head and neck cancer patients after 6 irradiation

Head and neck cancer post-radiotherapy

Eligibility Criteria

• Age: 28 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Al-Maarif University College: lead

Study Sites (1)

Ahmed A. Al-Kubaisi

Ramadi, Al-Anbar Governorate, 31001, Iraq

Location

Related Publications (2)

• 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: 33340075 RESULT

• 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.

  PMID: 35304084 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Chronic Periodontitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed A. Al-Kubaisi, PhD

  Al-Maarif University College

  STUDY DIRECTOR

• 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 CHAIR

• Hamid H. Enezei, PhD

  Department of Oral and Maxillofacial Surgery, College of Dentistry, University of Anbar

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2024
• First Posted: July 1, 2024
• Study Start: September 1, 2022
• Primary Completion: January 9, 2023
• Study Completion: June 23, 2023
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

IR (1)