Healthy VolunteerNCT03039868
Use of Pap Smear Derived Cells to Analyze the Expression of SLC6A14 and GPR81 Genes
An observational study of Healthy Volunteer, run by Texas Tech University Health Sciences Center.
Trial summary
SLC6A14 may serve as a biomarker for cervical dysplasia or cervical cancer. Read more about this study
- Who is it for?
- Ages 21 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Jun 2018
- 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 21 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will enroll a minimum of 150 and a maximum of 400 subjects. The subjects will all be women who present to the Texas Tech Obstetrics and Gynecology Clinics for exams and are having cervical Pap smear collected as part of their exams. The study subjects will be recruited after informed consent is obtained and they agree to the collection of 1-2 additional cervical Pap smear specimens to be used for the research study.
Who may be able to join
- Women who present to the TTUHSC Lubbock OBGYN Clinics for exams and are having cervical Pap smear collected as part of the evaluations.
- Women who have vaginal discharge will be also included in the study if they are having cervical Pap smear collected as part of their exam.
- Age criteria 21yr- 65yrs or more -per ASCCP guidelines for Pap smears.
- Patients on any medications will also be included- medications have no effect on Pap smear results.
Who cannot join
- Women who have had a hysterectomy.
- Women having vaginal Pap smears.
- Women with known HIV.
About this study
SLC6A14 may serve as a biomarker for cervical dysplasia or cervical cancer.
Read the detailed description
SLC6A14 amino acid transporter Previous research has shown that the expression of the amino acid transporter SLC6A14 is up-regulated in cervical cancer1. Studies on breast, colon and pancreatic cancer cells have shown that SLC6A14 amino acid transporter serves the role of supporting amino acid nutrition to these cancer cells2,3,4. It has also been shown that genetic deletion or pharmacologic blockade of the above transporter will suppress the growth of the tumor cells both in vitro and in vivo4,5,6.
We are interested in exploring the expression of SLC6A14 transporter in normal cervical epithelial cells, in cervical dysplasia and cervical cancer; and to see if expression of this transporter has any correlation to presence/severity of cervical dysplasia/cancer, and also to see if this may serve as a biomarker to predict or diagnose the presence of cervical dysplasia and cervical cancer.
GPR81, a G-protein coupled receptor for lactate Human vagina is predominantly colonized by Lactobacilli, which convert glycogen in the vaginal epithelial cells to lactic acid. Some species of Lactobacilli also produce hydrogen peroxide. Both lactate and H2O2 help to keep the vaginal pH low (acidic <4.5) and also help in preventing colonization of the vagina by pathogenic bacteria. When the levels of Lactobacilli in the vaginal micro environment change (as with certain vaginal infections, decline in estrogen levels etc), levels of lactate decline and H2O2 decline-thus predisposing women to vaginal infections.
Vaginal and cervical fluids contain lactate in millimolar concentrations. Recent studies have identified a G-protein-coupled cell-surface receptor for lactate,-called GPR81. Studies from Dr. Ganapathy's lab have shown that activation of the receptor GPR81 in B lymphocytes enhances the production of IgA antibody, which plays a role in defense mechanisms of mucosal surfaces. IgA antibodies are seen in high levels in the intestinal, colonic, lung mucosa as well as vaginal epithelial surfaces. These IgA antibodies protect the colonization of mucosal surfaces by pathogenic bacteria. Thus GPR 81 is an anti-inflammatory molecule. Hence it may inversely correlate with cervical dysplasia. We propose to investigate if the vaginal and cervical epithelial cells express this GPR81, whether GPR81 expression correlates to cervical dysplasia.
If a correlation exists between lactate levels and GPR81 expression, declining Lactobacilli levels with associated decline in lactate levels, could lead to decreased GPR81 expression on epithelial cells, and thus decline in IgA antibody secretion. This could be the reason for vaginal infections with decreased Lactobacilli. If infection with HPV virus occurs, this will lead to abnormalities in the Pap smear and potential cervical dysplasia in the future.
- Conditions
- Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal Pap smears | This is the control group. | |
| Abnormal Pap smears | This is the case group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of SLC6A14 and GPR81 transporter in cervical epithelial cells measured as "delta Ct" to correlate expression levels to cervical dysplasia and cervical cancer
Measured: Prospective study over a period of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study startDec 2016
- Primary completionMay 2018
- Study completionJun 2018
Why it stopped: results were not as hypothesized
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039868
- Sponsor's protocol ID
- L17-030
- Status last verified
- Nov 2019
- First submitted
- 30 Jan 2017
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Pap Smear Derived Cells to Analyze the Expression of SLC6A14 and GPR81 Genes
- ClinicalTrials.gov ID
- NCT03039868
- Acronym / sponsor ID
- L17-030
- Conditions
- Healthy Volunteer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: results were not as hypothesized
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 1 Feb 2017 (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.
SLC6A14 may serve as a biomarker for cervical dysplasia or cervical cancer.
Detailed description
SLC6A14 amino acid transporter Previous research has shown that the expression of the amino acid transporter SLC6A14 is up-regulated in cervical cancer1. Studies on breast, colon and pancreatic cancer cells have shown that SLC6A14 amino acid transporter serves the role of supporting amino acid nutrition to these cancer cells2,3,4. It has also been shown that genetic deletion or pharmacologic blockade of the above transporter will suppress the growth of the tumor cells both in vitro and in vivo4,5,6.
We are interested in exploring the expression of SLC6A14 transporter in normal cervical epithelial cells, in cervical dysplasia and cervical cancer; and to see if expression of this transporter has any correlation to presence/severity of cervical dysplasia/cancer, and also to see if this may serve as a biomarker to predict or diagnose the presence of cervical dysplasia and cervical cancer.
GPR81, a G-protein coupled receptor for lactate Human vagina is predominantly colonized by Lactobacilli, which convert glycogen in the vaginal epithelial cells to lactic acid. Some species of Lactobacilli also produce hydrogen peroxide. Both lactate and H2O2 help to keep the vaginal pH low (acidic <4.5) and also help in preventing colonization of the vagina by pathogenic bacteria. When the levels of Lactobacilli in the vaginal micro environment change (as with certain vaginal infections, decline in estrogen levels etc), levels of lactate decline and H2O2 decline-thus predisposing women to vaginal infections.
Vaginal and cervical fluids contain lactate in millimolar concentrations. Recent studies have identified a G-protein-coupled cell-surface receptor for lactate,-called GPR81. Studies from Dr. Ganapathy's lab have shown that activation of the receptor GPR81 in B lymphocytes enhances the production of IgA antibody, which plays a role in defense mechanisms of mucosal surfaces. IgA antibodies are seen in high levels in the intestinal, colonic, lung mucosa as well as vaginal epithelial surfaces. These IgA antibodies protect the colonization of mucosal surfaces by pathogenic bacteria. Thus GPR 81 is an anti-inflammatory molecule. Hence it may inversely correlate with cervical dysplasia. We propose to investigate if the vaginal and cervical epithelial cells express this GPR81, whether GPR81 expression correlates to cervical dysplasia.
If a correlation exists between lactate levels and GPR81 expression, declining Lactobacilli levels with associated decline in lactate levels, could lead to decreased GPR81 expression on epithelial cells, and thus decline in IgA antibody secretion. This could be the reason for vaginal infections with decreased Lactobacilli. If infection with HPV virus occurs, this will lead to abnormalities in the Pap smear and potential cervical dysplasia in the future.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Pap smears | – | –This is the control group. |
| Abnormal Pap smears | – | –This is the case group. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll a minimum of 150 and a maximum of 400 subjects. The subjects will all be women who present to the Texas Tech Obstetrics and Gynecology Clinics for exams and are having cervical Pap smear collected as part of their exams. The study subjects will be recruited after informed consent is obtained and they agree to the collection of 1-2 additional cervical Pap smear specimens to be used for the research study.
Key inclusion criteria (4 listed)
- Women who present to the TTUHSC Lubbock OBGYN Clinics for exams and are having cervical Pap smear collected as part of the evaluations.
- Women who have vaginal discharge will be also included in the study if they are having cervical Pap smear collected as part of their exam.
- Age criteria 21yr- 65yrs or more -per ASCCP guidelines for Pap smears.
- Patients on any medications will also be included- medications have no effect on Pap smear results.
Key exclusion criteria (3 listed)
- Women who have had a hysterectomy.
- Women having vaginal Pap smears.
- Women with known HIV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Expression of SLC6A14 and GPR81 transporter in cervical epithelial cells measured as "delta Ct" to correlate expression levels to cervical dysplasia and cervical cancer
Time frame: Prospective study over a period of 3 years.
Results and safety
The study was stopped early (reason given: results were not as hypothesized). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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 Healthy Volunteer, run by Texas Tech University Health Sciences Center.
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 4 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: stopped early, as of the sponsor's last update on 13 Nov 2019. 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?
The study was stopped early (reason given: results were not as hypothesized). 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?
Expression of SLC6A14 and GPR81 transporter in cervical epithelial cells measured as "delta Ct" to correlate expression levels to cervical dysplasia and cervical cancer (time frame: Prospective study over a period of 3 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 13 Nov 2019.