association between P.gingivalis strains in mouth and those in oral cancer and oesophageal cancer tissues

Completed

• Conditions: Malignant neoplasm of esophagus, unspecified, (2) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified,

• Registration Number: CTRI/2020/04/024835
• Lead Sponsor: INDIAN COUNCIL OF MEDICAL RESEARCH

Brief Summary

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|**Background:**

Oral cancer is the most common cancer in India amongst men, and accounts for around 30% of all cancers in India. Oesophageal cancer is the 6th most common cancer in India. Along with the common risk factors like tobacco and alcohol, bacteria have been established as risk factors for cancer. Porphyromonas gingivalis (*P. gingivalis*) is an anaerobic gram-negative bacterium that colonizes the oral epithelium and has been strongly associated with periodontal disease. It has been detected in both Oral squamous cell carcinoma (OSCC) and oesophageal squamous carcinoma tissue.

Reliable data addressing the impact of this bacterium and periodontitis on the causation of Oro-Oesophageal malignancies remain scarce.  Mere presence of the same species of an oral pathogen in the tumour tissue and in the periodontal pockets of a patient suffering from periodontal disease does not indicate an association between malignancy and periodontitis.  Since *P. gingivalis* has a strong association with periodontal diseases, examination of whether ***identical strains*** of *P. gingivalis* can be isolated from Oro-Oesophageal cancers and dental plaque specimens obtained from the same patient will go a long way in throwing light on the possible causal association between periodontal disease and Oro-Oesophageal malignancies.

 Â·       **Aim:**  Exploring the association between Porphyromans Gingivalis strains isolated from Dental Plaque and from  the tumor tissue of Oro-Oesophageal cancer patients

**Objectives**

·       To estimate **prevalence rate of *P. gingivalis*** in patients with Oral / Oesophageal cancers using anaerobic culturing and MALDI-TOFMS.

·       Perform **strain typing** of *P. gingivalis* isolates from the saliva, dental plaque, tumour tissue and adjoining healthy tissue of patients with Oral / Oesophageal cancer using Arbitrarily primed polymerase chain reaction (AP-PCR).

·       To explore the **association** between the *P. gingivalis* strains isolated from the dental plaque with those isolated from the cancerous tissue.

·       To **validate saliva** as a potential non invasive diagnostic fluid for *P. gingivalis* isolation.

·       To correlate *P. gingivalis* strains with periodontal health status

**Sample size** : Oesophageal cancer patients: 80; Oral cancer patients: 85

**Duration of study** : 3 year

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-05
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

Patients suffering from Oral Squamous Cell Carcinoma Patients suffering from Oesophageal Squamous Cell Carcinoma Patients who have not yet undergone any Surgical therapy/ Chemotherapy/ Radiotherapy for treatment of the carcinoma Patients willing to give informed consent Patients with minimum 20 teeth.

Exclusion Criteria

Patients with any malignancy other than squamous cell carcinoma of the oral cavity/ esophagus Patients undergoing any treatment for carcinoma or its recurrence History of antibiotic use in the previous three months Pregnant or lactating females Patients who received periodontal treatment within the last 6 months Patients who require antibiotic prophylaxis before examination Patients unwilling to participate in the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arbitrarily primed polymerase chain reaction (AP-PCR) fingerprinting of P. gingivalis isolates from dental plaque, saliva, healthy and tumour tissue in patients with Oral/ Oesophageal cancers	baseline

Secondary Outcome Measures

Name	Time	Method
To estimate the prevalence of Periodontal disease in patients suffering from Oral/ Oesophageal cancers by recording the Periodontal status of all subjects
Correlation of the prevalence rate of P.gingivalis in saliva with that in dental plaque samples and tumour tissues	baseline
Estimation of prevalence rate of P. gingivalis in saliva & dental plaque of patients with Oral/ Oesophageal cancers using MALDI-TOF MS	baseline
Estimation of prevalence rate of P. gingivalis in healthy and tumour tissue of patients with Oral/ Oesophageal cancers using MALDI-TOF MS.	baseline
Correlation of P. gingivalis strain with periodontal health status	baseline

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, CHANDIGARH, India

PGIMER

🇮🇳Chandigarh, CHANDIGARH, India

DR SHIPRA GUPTA

Principal investigator

919876034881

teena1472@yahoo.in