Cervical Intraepithelial NeoplasiaNCT02198365
Comparison of Human Papillomavirus Integrated DNA and Messenger RNA in Cervical Neoplasia
An observational study of Cervical Intraepithelial Neoplasia, run by Cathay General Hospital at 1 site in Taiwan.
Trial summary
The investigators hypothesis is HPV integration could result in expression of oncogene transcripts, and not only constitutive expression but also the level of expression will be decisive for transformation and the maintenance of the malignant phenotype. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2007to Mar 2009
- 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 20 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will examine 250 baseline liquid-based cytology specimens from women with 100 low-grade squamous intraepithelial lesions (LSILs), 100 high-grade squamous intraepithelial lesions (HSILs), 10 microinvasions and 40 invasive cervical cancers.
Who may be able to join
- cervical neoplasia
- HPV infection patient
Who cannot join
- no HPV infection
- no intra-epithelial neoplasia lesion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Human Papillomavirus Integrated DNA and Messenger RNA for Detection and Prediction in Progression of Cervical Neoplasia
The investigators hypothesis is HPV integration could result in expression of oncogene transcripts, and not only constitutive expression but also the level of expression will be decisive for transformation and the maintenance of the malignant phenotype. Moreover, the expression and level of HPV viral transcripts not HPV DNA viral loads is correlated to the severity in cervical intraepithelial neoplasia (CIN) and cervical carcinomas (CxCa).
Read the detailed description
In the investigators proposal, the investigators will examine at least 250 baseline liquid-based cytology specimens from women with normal cytology, low-grade squamous intraepithelial lesions (LSILs), high-grade squamous intraepithelial lesions (HSILs), microinvasions and invasive cervical cancers. Specimens will be tested for HPV DNA using HPV blot and type-specific PCR including type 16, 18, 52, 58, 31, 33, 39, 45, 51, 56, 59, 68, 6, and 11. Cervical specimens from women with HPV DNA types 16, 18, 52, 58, 31 and 33, which are the most prevalent oncogenic types in Taiwan, will be examined for physical status of viral DNA tested by real-time PCR and FISH, along with level of expression in mRNA.
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- mRNA,, DNA,, integrated HPV DNA, human papillomavirus,, cervical neoplasia
- Medical subject headings
- Uterine Cervical Dysplasia
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 |
|---|---|---|
| Group 2 | Group 1: normal pap smear Group 2: cervical neoplasia |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of mRNA expression
Measured: 12 month
Secondary outcomes (1)
The integrated HPV DNA
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startJan 2007
- Primary completionJan 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cathay General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Chih-Ming Ho, Cathay General Hospital
- Investigators
- Chih-Ming Ho, Study chair, Gynecologic Cancer Center, Cathay General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198365
- Sponsor's protocol ID
- TGOG-128
- Status last verified
- Jul 2014
- First submitted
- 4 Jan 2009
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Human Papillomavirus Integrated DNA and Messenger RNA for Detection and Prediction in Progression of Cervical Neoplasia
- ClinicalTrials.gov ID
- NCT02198365
- Acronym / sponsor ID
- TGOG-128
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- mRNA,, DNA,, integrated HPV DNA, human papillomavirus,, cervical neoplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Cathay General HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jan 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 23 Jul 2014 (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 investigators hypothesis is HPV integration could result in expression of oncogene transcripts, and not only constitutive expression but also the level of expression will be decisive for transformation and the maintenance of the malignant phenotype. Moreover, the expression and level of HPV viral transcripts not HPV DNA viral loads is correlated to the severity in cervical intraepithelial neoplasia (CIN) and cervical carcinomas (CxCa).
Detailed description
In the investigators proposal, the investigators will examine at least 250 baseline liquid-based cytology specimens from women with normal cytology, low-grade squamous intraepithelial lesions (LSILs), high-grade squamous intraepithelial lesions (HSILs), microinvasions and invasive cervical cancers. Specimens will be tested for HPV DNA using HPV blot and type-specific PCR including type 16, 18, 52, 58, 31, 33, 39, 45, 51, 56, 59, 68, 6, and 11. Cervical specimens from women with HPV DNA types 16, 18, 52, 58, 31 and 33, which are the most prevalent oncogenic types in Taiwan, will be examined for physical status of viral DNA tested by real-time PCR and FISH, along with level of expression in mRNA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 2 | – | –Group 1: normal pap smear Group 2: cervical neoplasia |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will examine 250 baseline liquid-based cytology specimens from women with 100 low-grade squamous intraepithelial lesions (LSILs), 100 high-grade squamous intraepithelial lesions (HSILs), 10 microinvasions and 40 invasive cervical cancers.
Key inclusion criteria (2 listed)
- cervical neoplasia
Key exclusion criteria (2 listed)
- no HPV infection
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
level of mRNA expression
Time frame: 12 month
1 secondary outcome
The integrated HPV DNA
Time frame: 12 months
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 23 Jul 2014.
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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.
Chih-Ming Ho study chair
Gynecologic Cancer Center, Cathay General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Intraepithelial Neoplasia, run by Cathay General Hospital at 1 site in Taiwan.
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 2 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 23 Jul 2014. 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 Taiwan. 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.
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.
What does the primary outcome measure?
level of mRNA expression (time frame: 12 month). 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 23 Jul 2014.