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Cervical Intraepithelial Neoplasia clinical trials

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NCT ID: NCT00596258 Completed - Clinical trials for Cervical Intraepithelial Neoplasia

A Two-Stage Phase 2 Study Of A-007 Topical Gel in High-Grade Squamous Intraepithelial Lesions (HSIL)

TG-003
Start date: November 2007
Phase: Phase 2
Study type: Interventional

A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the safety and efficacy of A-007, when used to treat high-grade cervical dysplasia.

NCT ID: NCT00526370 Completed - Clinical trials for Uterine Cervical Neoplasms

Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests

Start date: August 2007
Phase: Phase 0
Study type: Observational

The purpose of this study is to examine for HPV E6/E7 mRNA in tampon self-tests, and compare with the cytological and histological diagnoses. Study Hypothesis: Expression of HPV E6/E7 mRNA in Tampon self-tests are a suitable alternative to the routine cervical smear.

NCT ID: NCT00513123 Completed - Cervical Cancer Clinical Trials

Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia

Start date: September 2002
Phase: N/A
Study type: Observational

The overall objective of this study is to identify potential improvements for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using digital colposcopy for colposcopy for fluorescence spectroscopy. Other Objectives: - To measure digital fluorescence and reflectance images in vivo of sites in the human cervix. - To evaluate the effect of acetic acid in the image contrast obtained. - Compare the device performance to colposcopy and pathologic analysis of tissue removed at colposcopy.

NCT ID: NCT00511615 Completed - Cervical Cancer Clinical Trials

Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia

Start date: March 2005
Phase: N/A
Study type: Observational

The hypothesis of this research project is that topical application of the anti-EGFR or anti-E6/E7 contrast agents followed by optical imaging will yield images that reflect spatial variations in expression that correlate with the presence of cervical precancer. To gather feasibility data the investigators will: 1. Obtain cervical specimens from women with high grade squamous intraepithelial lesions (HGSILs) being treated with the loop electrosurgical excision procedure (LEEP). 2. After Loop Electrosurgical Excision Procedure (LEEP) is performed, obtain low and high resolution optical images before and after applying contrast agents topically to the epithelial surface of the tissue for 30 minutes before rinsing. 3. Submit the specimen for histology, and have it sectioned and stained using both H&E and immunohistochemical staining for EGFR or E6/E7. The images will be reconstructed into a two dimensional map delineating areas of Cervical Intraepithelial Neoplasia (CIN) and of EGFR or E6/E7 overexpression. Maps of the pathology will be compared to those obtained from the intact cervix exposed to the contrast agent.

NCT ID: NCT00505726 Completed - Cervical Cancer Clinical Trials

Reflectance Confocal Imaging in Cervical Cancer Patients

Start date: November 2001
Phase: Phase 1
Study type: Observational

The goal of this clinical research study is to see if reflectance confocal microscopy works as well as standard methods to detect cancer of the cervix or precancerous lesions. Primary Objectives: 1. To identify potential clinical advantages for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using reflectance confocal microscopy. 2. To obtain real time reflected light images in vivo of sites in the human cervix. 3. To access the effects of acetic acid as a contrast agent for in vivo reflectance confocal imaging. 4. Evaluate the depth of penetration for the fiber optic confocal device and analyze the diagnostic value of images taken from different depths. 5. Determine the sensitivity and specificity of this device for the diagnosis of CIN.

NCT ID: NCT00479375 Completed - Cervical Cancer Clinical Trials

Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Cancer Screening

SWEDESCREEN
Start date: May 1997
Phase: N/A
Study type: Interventional

Human papillomavirus (HPV)-based cervical screening is known to increase sensitivity for detection of high-grade cervical intraepithelial neoplasia (CIN). Randomized trials of longitudinal efficacy are required to assess whether these gains represent overdiagnosis or a protective effect. Methods: A total of 12527 women, aged 32-38, attending population-based invitational screening in Sweden were randomized 1:1 to HPV test and cytology (intervention arm) or cytology only (control arm). HPV-positive women were invited for a second HPV test at least one year later and women with type-specific persistent infections were then invited to colposcopy. A similar number of random double-blinded procedures are performed in the control arm. Women are followed with comprehensive registry-based follow-up. Primary outcome is the relative rates of CIN grade 2 or worse (CIN2/CIN3+) found in subsequent screening. Secondary outcomes are the relative rates of CIN2/CIN3+ found in the aseline screening and outcomes stratified by grade of CIN (CIN 2 or CIN3+).

NCT ID: NCT00458562 Completed - Cervical Cancer Clinical Trials

Identifying Genes That Predict Risk of Developing Cervical Intraepithelial Neoplasia or Invasive Cervical Cancer

Start date: January 2006
Phase: N/A
Study type: Observational

RATIONALE: Finding certain changes in genes may help doctors predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer and may help the study of cancer in the future. PURPOSE: This clinical trial is studying genes that may predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer.

NCT ID: NCT00443313 Completed - Clinical trials for Cervical Intraepithelial Neoplasia

Human Papillomavirus (HPV) Testing to Improve Cervical Cancer Screening in the Mississippi Delta

Start date: January 24, 2007
Phase:
Study type: Observational

Background: - Cancer of the cervix (bottom third of the uterus, or womb) can be prevented by regular Pap tests (also called Pap smears), which check for changes in the cells of the cervix. Because many women in the United States have regular Pap smears, cervical cancer is not common in this country. However, the disease is common among women in the Mississippi Delta because of poor participation in screening programs. - The major causes of cervical cancer are persistent human papillomaviruses (HPV) infection by cancer-associated HPV types and lack of screening. These viruses cause an infection that often goes away by itself, but if it does not go away, over a long time lead to cervical cancer. HPV causes cervical abnormalities, which are detected by Pap smears and then treated. Objectives: -To determine whether an at-home self-collection method for obtaining cells from the cervix can be a simple, safe and inexpensive way to screen for cervical cancer for women who don t go to the health clinic regularly. Eligibility: - Women who reside in the counties of Leflore, Sunflower, Washington or Tallahatchie, Mississippi. - Women between 26 and 65 years of age who are not pregnant and who have not had a hysterectomy. Design: Screening study participants undergo the following: - The doctor takes a cervical sample using the same self-collection device that women will use at home to self-collect. - Pelvic examination and Pap test. For this test, the woman lies on an exam table and the doctor inserts an instrument called a speculum into the vagina, opening it to see the cervix. A special brush is used to take a few cells from the cervix. The cells are placed on a glass slide and sent to a lab for examination. - Cervical cell specimen collection using an at-home self-collection kit that participants will use at home after 2 weeks - At-home self-collection by participant after 2 weeks. - Referral to a doctor for follow-up care, if needed. - Colposcopy (see below) in all women with a Pap test that is abnormal or positive for HPV and for some women with a normal smear. Colposcopy study participants undergo the following: - The doctor takes a cervical sample using the same self-collection device that women will use at home to self-collect. - Colposcopy, an exam in which the doctor examines the cervix using a light and looks through a magnifying device to see if there is any abnormal tissue on the cervix. During this exam, the doctor may remove a small sample of tissue to diagnose any abnormality. Participants also have a sample collected using the self-collection kit. - At-home cervical sample collection by participant after 2 weeks. - Notification if further medical care is required and treatment if the biopsy looks abnormal.

NCT ID: NCT00377845 Completed - Clinical trials for Uterine Cervical Neoplasms

Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.

Start date: September 2006
Phase: Phase 0
Study type: Interventional

The purpose of this study is to compare suitability, specificity and sensitivity of the routine smear and the tampon self-test women perform at home. Study hypothesis: The tampon self-test correspond to the routine cervical smear.

NCT ID: NCT00374114 Completed - Cervical Dysplasia Clinical Trials

A Pilot Study to Evaluate Ultrasonic Surgical Aspiration as a Treatment Modality for Cervical Dysplasia

Start date: January 2004
Phase: N/A
Study type: Interventional

Ultrasonic surgical aspiration of the cervix may be an effective method of treating cervical dysplasia without compromising the integrity of the cervix in reproductive age women.