Field Cancerization for Cannabis SmokersNCT03334279
Effect of Cannabis and Cigarette Smoking on Oral Mucosa
An observational study of Field Cancerization for Cannabis Smokers, run by Cairo University.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Field Cancerization for Cannabis Smokers
- What is being tested?
- Cigarette smokers and Simultaneous cigarette and cannabis smokers
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: routine patients already coming for simultaneous dental or surgical procedures..
Who may be able to join
- 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.
Who cannot join
- Exposure to other carcinogens.
- un-clear smoking history.
- medically compromised patients
About this study
Official title: Detection of Field Cancerization in the Clinically Normal Oral Mucosa of Cannabis and Cigarette Smokers (Ex-vivo Study)
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.
Read the detailed description
Roles and Responsibilities:
- 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.
- 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.
- Eman Desoky (E.D.) sample size calculation, statistician,Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Evidence Based Dentistry Committee (CEBD)help in reporting study protocol following SPIRIT guidelines,Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- 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.
- Conditions
- Field Cancerization for Cannabis Smokers
- Being tested
- Cigarette smokers, Simultaneous cigarette and cannabis smokers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cigarette smokersOther
frequent cigarette smoking for not less than 5 years
Simultaneous cigarette and cannabis smokersOther
frequent cigarette and cannabis smoking for not less than 5 years
| Study group | Role | What they receive |
|---|---|---|
| non smokers | Not described | |
| cigarette smokers | Cigarette smokers to be included in the study must be frequent smokers (at least 10 cigarettes a day) for a period not less than 5 years. Receives: Other: Cigarette smokers | |
| simultaneous cigarette and cannabis smokers | frequent cigarette smokers (at least 10 cigarettes a day) and frequent cannabis smoker (at least 3 times/week) for not less than 5 years. Receives: Other: Simultaneous cigarette and cannabis smokers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: not less than 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study startJan 2018 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Field Cancerization for Cannabis SmokersStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Abdelwahed Kotb, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334279
- Sponsor's protocol ID
- CEBD-CU_2017-10-27
- Status last verified
- Oct 2017
- First submitted
- 21 Oct 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Field Cancerization in the Clinically Normal Oral Mucosa of Cannabis and Cigarette Smokers (Ex-vivo Study)
- ClinicalTrials.gov ID
- NCT03334279
- Acronym / sponsor ID
- CEBD-CU_2017-10-27
- Conditions
- Field Cancerization for Cannabis Smokers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Roles and Responsibilities:
- 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.
- 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.
- Eman Desoky (E.D.) sample size calculation, statistician,Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Evidence Based Dentistry Committee (CEBD)help in reporting study protocol following SPIRIT guidelines,Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non smokers | – | – |
| cigarette smokers | – | Other: Cigarette smokersCigarette smokers to be included in the study must be frequent smokers (at least 10 cigarettes a day) for a period not less than 5 years. |
| simultaneous cigarette and cannabis smokers | – | Other: Simultaneous cigarette and cannabis smokersfrequent cigarette smokers (at least 10 cigarettes a day) and frequent cannabis smoker (at least 3 times/week) for not less than 5 years. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- routine patients already coming for simultaneous dental or surgical procedures..
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Exposure to other carcinogens.
- un-clear smoking history.
- medically compromised patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cigarette smokersfrequent cigarette smoking for not less than 5 years | Other | cigarette smokers |
| Simultaneous cigarette and cannabis smokersfrequent cigarette and cannabis smoking for not less than 5 years | Other | simultaneous cigarette and cannabis smokers |
Primary outcome
P53 expression as a surrogate marker for field cancerization
Time frame: not less than 5 years
The areas containing the most uniformly stained tissues will be chosen for evaluation in area-area/area-percent measurments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Field Cancerization for Cannabis Smokers, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P53 expression as a surrogate marker for field cancerization (time frame: not less than 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.