HealthyEarly Phase 1NCT01038934
DNA of Oral Cytobrush in Three Means Conservation
A Early Phase 1 study testing samples collected by buccal cytobrush in people with Healthy, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
The aim of this study is to analyze genomic DNA of buccal cytobrush stored in three means conservation. Read more about this study
- Who is it for?
- Ages 20 to 33 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- samples collected by buccal cytobrush
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2006to Dec 2009
- Phase
- Early Phase 1
- 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 20 to 33 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy young
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Dentistry, Sao Paulo State University, Unesp, Araçatuba/SP
Araçatuba, São Paulo
About this study
Official title: Evaluation of Genomic DNA of Oral Cytobrush in Three Means Conservation
The aim of this study is to analyze genomic DNA of buccal cytobrush stored in three means conservation.
Read the detailed description
Blood samples are an excellent source of large amounts of genomic DNA. However, alternative sources are often needed in epidemiological studies because of difficulties in obtaining blood samples.
- Conditions
- Healthy
- Being tested
- samples collected by buccal cytobrush
- Keywords
- Buccal Mucosa, DNA, Polymerase Chain Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
samples collected by buccal cytobrushProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| buccal cytobrhsh | Experimental | healthy young Receives: Procedure: samples collected by buccal cytobrush |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startMar 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Investigators
- Glauco I Miyahara, Professor, Principal investigator, Univ. Estadual Paulista
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038934
- Sponsor's protocol ID
- upeclin/FOA-Unesp-04
- Status last verified
- Dec 2009
- First submitted
- 22 Dec 2009
- Last updated
- 24 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Genomic DNA of Oral Cytobrush in Three Means Conservation
- ClinicalTrials.gov ID
- NCT01038934
- Acronym / sponsor ID
- upeclin/FOA-Unesp-04
- Conditions
- Healthy
- Keywords
- Buccal Mucosa, DNA, Polymerase Chain Reaction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 24 Dec 2009 (estimated)
- 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 analyze genomic DNA of buccal cytobrush stored in three means conservation.
Detailed description
Blood samples are an excellent source of large amounts of genomic DNA. However, alternative sources are often needed in epidemiological studies because of difficulties in obtaining blood samples.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| buccal cytobrhsh | Experimental | Procedure: samples collected by buccal cytobrushhealthy young |
Who may qualify
- Ages
- 20 to 33 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy young
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| samples collected by buccal cytobrush | Procedure or surgery | buccal cytobrhsh |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2009.
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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.
Glauco I Miyahara, Professor principal investigator
Univ. Estadual Paulista
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing samples collected by buccal cytobrush in people with Healthy, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 24 Dec 2009.