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Cervical CancerNCT00854269

Screening and Identification of Biomarkers on Cervical Cancers

A study testing surgery in people with Cervical Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Cervical cancer the most frequent neoplasm and the fifth mortality rate of malignancies of the women in the world. It results in about 1,000 women in Taiwan and about 200,000 women worldwide dying of cervical cancer each year. Read more about this study

Who is it for?
Ages 25 to 80 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
surgery
Type of treatment
Surgery or procedure
How many people
250 participants
Where
1 siteTaiwan
Study dates
Jan 2007to Jan 2011
Phase
Interventional
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 25 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Healthy volunteers
  • People infected with HPV type 16 but without CIN lesions
  • Patients with CIN lesions
  • Patients with cervical cancer from National Taiwan University Hospital
  • Informed consent is obtained, and the protocols are reviewed and approved by the appropriate Investigative Review Boards.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

WEN-FANG CHENG, Associate Professor contact

886-2-23123456

wenfangcheng@yahoo.com

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Taipei, 100

    WEN-FANG CHENG, ASSOCIATE PROFESSOR, 886-2-23123456, wenfangcheng@yahoo.com

    Recruiting

Other trials in Taiwan

About this study

Official title: Screening and Identification of Novel Diagnostic and Prognosis Biomarkers on Cervical Cancers

Cervical cancer the most frequent neoplasm and the fifth mortality rate of malignancies of the women in the world. It results in about 1,000 women in Taiwan and about 200,000 women worldwide dying of cervical cancer each year. Human papilloma viruses (HPV) have been consistently implicated in causing cervical cancer especially those high-risk types (HPV 16,18,31,45) have been strongly associated with cervical cancer. Around 50-80 % of women are infected by HPV within their whole lives. However, only 1% of HPV-infected women have cervical cancer eventually. Seventy and 91% of HPV infection could be cleaned up by host immune responses within 1 and 2 years later. It shows that host immunity plays an important role in the progression, persistence, or regression of HPV infection.

There are two main defense lines in the host immunity including innate immunity and adoptive immunity. Adoptive immunity plays more important roles in the defense of HPV infections than innate immunity. The adoptive immunity could be further divided into humoral immunity and cell-mediated immunity. Humoral immunity regulated by Th2 helper T lymphocytes to generate memory B cells to produce antibody which provide the protective function to HPV infection. Cell-mediated immunity regulated by Th1 helper T lymphocytes to induce antigen-specific cytotoxic T cells which could kill the HPV-infected cells. Although there are many researches focused on the immunity to HPV infection, there is no conclusion about the relationship between humoral and cell-mediated immunities on HPV infection and roles of humoral and cell-mediated immunities in the prognosis of HPV-infected population and cervical cancer patients.

Our research team has focused on the establishment of platforms on cell-mediated immunity to HPV infection and on the correlation of cell-mediated immunity and prognosis of HPV-infected population and cervical cancer patients for years. In order to survey the host immunity to HPV infection more comprehensively, we propose this 3-year proposal. First, we would like to set up the platforms to survey the humoral immunity to HPV infection in normal population and patients with CIN lesion or cervical cancer. Second, we would to elucidate the correlation between humoral immunity and status and clinico-pathologic items of HPV-infected populations. Third, we would like to survey if the humoral immunity correlate with the prognosis of patients with cervical lesions. Fourth, we would like to elucidate the correlation betweenHLA haplotype and humoral immunity in HPV-infected populations. Our research results will have a more comprehensive overview in the host immunity to HPV infection and its related diseases. It could provide more information in the prevention and treatment of HPV infection in the future.

Conditions
Cervical Cancer
Being tested
surgery
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • surgeryProcedure or surgery

    cervical biopsy or specimen of hysterectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    Measured: from disease diagnosis to death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2009 (estimated)
  2. Study startJan 2007
  3. Primary completionMay 2008 (estimated)
  4. Study completionJan 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00854269
Sponsor's protocol ID
200705075R
Status last verified
Mar 2009
First submitted
1 Apr 2008
Last updated
24 Mar 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing surgery in people with Cervical Cancer, run by National Taiwan University 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 5 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: status not confirmed, as of the sponsor's last update on 24 Mar 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact WEN-FANG CHENG, Associate Professor (886-2-23123456, wenfangcheng@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: from disease diagnosis to death). 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 24 Mar 2009.

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