Effect of Cannabis and Cigarette Smoking on Oral Mucosa

Field Cancerization for Cannabis Smokers Clinical Trial

Official title:

Detection of Field Cancerization in the Clinically Normal Oral Mucosa of Cannabis and Cigarette Smokers (Ex-vivo Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03334279
• Other study ID #: CEBD-CU_2017-10-27
• Status: Not yet recruiting
• Phase: N/A
• First received: October 21, 2017
• Last updated: November 2, 2017
• Start date: January 2018
• Est. completion date: March 2020

Study information

• Verified date: October 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to detect P53 expression in clinically normal oral mucosa of cigarette smokers, simultaneous cigarette and cannabis smokers and non-smokers as a surrogate marker for field cancerization.

Description:

Roles and Responsibilities:

1. Ali Abd El Wahed Abd El Fatah Kotb (A.K.) operator, data enterer, Assistant lecturer, Oral and Maxillofacial Pathology, Faculty of Oral and Dental Medicine, Cairo university, Egypt.

2. Professor Dr. Heba Dahmoush (H.D.) main supervisor, data monitoring,auditing professor, Oral and Maxillofacial Pathology, Faculty of Oral and Dental Medicine, Cairo university, Egypt.

3. Eman Desoky (E.D.) sample size calculation, statistician,Faculty of Oral and Dental Medicine, Cairo University, Egypt.

4. Evidence Based Dentistry Committee (CEBD)help in reporting study protocol following SPIRIT guidelines,Faculty of Oral and Dental Medicine, Cairo University, Egypt.

5. Research Ethics Comittee (CREC)protocol reviewer in order to protect the right, safety, dignity and well-being of the participants, Faculty of Oral and Dental Medicine, Cairo University, Egypt.

1- Intervention: A.K. will collect specimens from cigarette smokers and simultaneous cigarette and cannabis smokers. then the expression of p53 as a marker for field cancerization will be investigated in formaline fixed paraffine embedded specimens of mucosal biopsies obtained from the oral mucosa of both groups.

2-comparator: mucosal biopsies from non smokers will be investigated as a copmaratitive to smokers group.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• frequent smokers (at least 10 cigarettes a day) for a period not less than 5 years.

• Simultaneous smokers to be included in the study must be frequent cigarette smokers (at least 10 cigarettes a day) for a period not less than 5 years plus frequent cannabis smoker (at least 3 times per week) for a period not less than 5 years.

Exclusion Criteria:

• Exposure to other carcinogens.

• un-clear smoking history.

• medically compromised patients

Related Conditions & MeSH terms

• Field Cancerization for Cannabis Smokers
• Marijuana Abuse

Intervention

Other:
• Cigarette smokers
frequent cigarette smoking for not less than 5 years
• Simultaneous cigarette and cannabis smokers
frequent cigarette and cannabis smoking for not less than 5 years

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P53 expression as a surrogate marker for field cancerization	The areas containing the most uniformly stained tissues will be chosen for evaluation in area-area/area-percent measurments	not less than 5 years