| CTRI Number |
CTRI/2020/04/024835 [Registered on: 24/04/2020] Trial Registered Prospectively |
| Last Modified On: |
03/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
association between P.gingivalis strains in mouth and those in oral cancer and oesophageal cancer tissues |
|
Scientific Title of Study
|
A cross sectional investigation into the possible association between Porphyromonas gingivalis strains isolated from the Oral Microbiome and Oro-Oesophageal Cancer patients by MALDI-TOF MS and AP-PCR |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SHIPRA GUPTA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
ORAL HEALTH SCIENCES CENTRE, SECTOR 12, PGIMER |
| Address |
ASSISTANT PROFESSOR, UNIT OF PERIODONTICS, ROOM NUMBER 101, ORAL HEALTH SCIENCES CENTRE, SECTOR 12, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
teena1472@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHIPRA GUPTA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
ORAL HEALTH SCIENCES CENTRE, SECTOR 12, PGIMER |
| Address |
ASSISTANT PROFESSOR, UNIT OF PERIODONTICS, ROOM NUMBER 101, ORAL HEALTH SCIENCES CENTRE, SECTOR 12, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
teena1472@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
DR SHIPRA GUPTA |
| Designation |
Assistant Professor |
| Affiliation |
ORAL HEALTH SCIENCES CENTRE, SECTOR 12, PGIMER |
| Address |
ASSISTANT PROFESSOR, UNIT OF PERIODONTICS, ROOM NUMBER 101, ORAL HEALTH SCIENCES CENTRE, SECTOR 12, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
teena1472@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Indian council of medical research |
|
|
Primary Sponsor
|
| Name |
INDIAN COUNCIL OF MEDICAL RESEARCH |
| Address |
ANSARI NAGAR, NEW DELHI |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SHIPRA GUPTA |
PGIMER |
ROOM NUMBER 101, ORAL HEALTH SCIENCES CENTRE
Chandigarh
CHANDIGARH |
919876034881
teena1472@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified, (2) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
74.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
To estimate the prevalence of Periodontal disease in patients suffering from Oral/ Oesophageal cancers by recording the Periodontal status of all subjects
|
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 the prevalence rate of P.gingivalis in saliva with that in dental plaque samples and tumour tissues |
baseline |
| Correlation of P. gingivalis strain with periodontal health status |
baseline |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
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. · 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 |
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