high risk HPV DNA testing for Cervical Intraepithelial Neoplasia
This study is evaluating whether HPV testing is as good as colposcopy in the follow-up of women treated for cervical high grade lesions.
See full descriptionAbout the trial for Cervical Intraepithelial Neoplasia
Treatment Groups
This trial involves 2 different treatments. High Risk HPV DNA Testing is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
Eligibility
This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Cervical Intraepithelial Neoplasia or one of the other 2 conditions listed above. There are 4 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether high risk HPV DNA testing will improve 1 primary outcome and 1 secondary outcome in patients with Cervical Intraepithelial Neoplasia. Measurement will happen over the course of 6 months post treatment.
Patient Q & A Section
How many people get cervical intraepithelial neoplasia a year in the United States?
CIN II,III and adenocarcinoma are the main precancers identified by Papanicolaou smear in the United States. CIN I is uncommon, although the risk of progression to adenocarcinoma in HPV infected women is significant.
What are common treatments for cervical intraepithelial neoplasia?
The current USPSTF guidelines encourage careful consideration before recommending for or against human papillomavirus vaccine for girls age 11 or 12. It is important to note that while there is good evidence to support HPV vaccines that reduce the number of new STIs and high-grade abnormal cytology, the evidence is less as for CIN screening due to inconsistent methodology in methodology. Therefore, individualized decision making needs to take note of the cost/benefit ratio for these girls.
What are the signs of cervical intraepithelial neoplasia?
The present study showed the significance of clinical and histopathological features in cervical neoplasia and their influence on the patient's quality of life. Most importantly, it highlighted the effect of treatment on the quality of life, especially concerning the cervical cancer stage.
Can cervical intraepithelial neoplasia be cured?
CIN cannot be "cured" once it has been detected. CIN-3, even when detected early, can progress into cancer in many cases. To be truly effective, cervical cancer prevention programs should also strive to keep women's Pap smears uptaken when appropriate.
What causes cervical intraepithelial neoplasia?
It is unknown what exactly causes CIN. The most likely explanation is that there is a malfunction in the DNA machinery which makes it prone to malfunction, or that the DNA is stressed following exposure to other factors. All these factors are involved in oncogenesis. The main risk factors are age and lifetime cumulative exposure to HPV infections. Smoking and the number of sexual partners seem not to increase the cancer risk.
What is cervical intraepithelial neoplasia?
CIN is a precancerous condition that is defined by columnar appearance of cells in squamous interepithelial cells in the uterus. CIN is not a carcinoma (cancer). There is no treatment to prevent progression to cervical cancer. It is graded based on the cellular atypia and the degree of dysplasia. When CIN is found in women without symptoms, close follow up is not usually necessary. Larger studies are required to establish whether treatment can prevent progression of CIN, which in an advanced stage can lead to cervical cancer. If CIN is found in an otherwise asymptomatic woman, colposcopy is the only means to assess its progression.
What is the average age someone gets cervical intraepithelial neoplasia?
The average age of presentation with cervical dysplasia is 41 years. Women presenting for screening should not be discouraged from pursuing further study in primary prevention.
Has high risk hpv dna testing proven to be more effective than a placebo?
The use of the hr-p16 assay in the treatment of CIN 2/3+ lesions in women, when compared with a placebo, has resulted in a reduced recurrence rate after biopsy (25.0% vs. 51.7%; p=0.03) and a decreased total number of rebiopsies (3.3±1.6 vs. 7.9±2.2; p=0.03). Although the use of high risk HPV dna testing does appear to be more effective than a placebo in preventing recurrences of CIN 2/3+ lesions, a placebo should be regarded as an acceptable alternative or complementary first-line treatment option if the choice is made between these two strategies.
Does high risk hpv dna testing improve quality of life for those with cervical intraepithelial neoplasia?
The high risk HPV results did not improve the women's QOL, but created some anxiety among women with <CIN3. The study concluded that the results did not justify the additional cost; however a larger study is warranted to confirm the results of this pilot study.
How serious can cervical intraepithelial neoplasia be?
At present these data provide a more realistic estimation of the true risk of progression to invasive cervical cancer, and suggest that a cure is not likely: there are currently no clinical trials to study the management of CIN (http://www.gpn.com/lib[ra](https://www.withpower.com/clinical-trials/ra)ry/CIN0/index.html) and only a limited number of large trials of women at high risk (http://www.gpn.com/library/CIN1/index.html). The most recent published data show the rate of high grade lesions rising from 14% (women with ASC-US and HSIL) to 53% (high grade squamous intraepithelial lesion).
What is the primary cause of cervical intraepithelial neoplasia?
Results from a recent paper, it was found that the rate of progression of cervical intraepithelial neoplasia was higher in smokers than in nonsmokers. The reason for this may be due to the ability of smoke to act as a carcinogen. Because cervical intraepithelial neoplasia is associated with cervical cancer, physicians should focus on smoking cessation as it may reduce the risk of cervical intraepithelial neoplasia development.
What are the common side effects of high risk hpv dna testing?
The main side effects of high risk HPV testing are bleeding and pain from the procedure, soreness, and minor bleeding at the test site. Allergy or an allergic reaction to the test site often occurs and is transient. Allergy and allergic reactions occurred in 4.3% of the group. The rate of bleeding is 3.8%. Pain was experienced by 2.1% of the test subjects. Minor/major bleeding rates are low, less than 5.0% for the group. Rare bleeding (blood in stool, bowel perforation, etc.) occurred in < 1% of the tests. In 2.1% of the tests, 1 or both of the test sites had minor bleeding.