Clinical Trials Logo

Clinical Trial Summary

This study, conducted by the National Cancer Institute and the University of Oklahoma, will look for changes in cervix cells and other samples that may be signs of cervical disease. Human papilloma virus, or HPV, is a common infection of the genitalia in women that usually goes away by itself. If HPV infection does not go away, it might turn into cancer of the cervix, although this is rare. This study will examine why many HPV infections go away and why a few persist and lead to cervical cancer.

Women 18 years of age and older who are referred for colposcopy (examination of the vagina and cervix using an instrument with a magnifying lens) at the University of Oklahoma following Pap smear diagnosis may be eligible for this study. Women will be in one of the following diagnostic categories:

- Cancer: Stage 1-2 only.

- Precancer: Cervical intraepithelial neoplasia (CIN3).

- HPV-infected: Positive for any of the 13 known cancer-causing HPV types, but not diagnosed with cancer or CIN3.

- Normal: Negative for cancer-causing HPV and normal tissue laboratory results.

Participants will undergo the following procedures:

- Questionnaire: Covers demographic information (such as age, race, ethnicity, marital status, etc.), pregnancy history, menstrual and sexual history, contraceptive history, hormone medication history, medical history, smoking history, physical development, family history, and health care access.

- Blood test: 2 tablespoons of blood drawn.

- Colposcopy.

- Procedure to collect a sample of cervical cells and fluids for HPV testing and research.


Clinical Trial Description

For the past twenty years, large epidemiologic natural history studies have played a crucial role in achieving our current understanding of cervical neoplasia. We now know that human papillomavirus (HPV) infection is necessary but not sufficient cause of cervical cancer. Cervical pathogenesis evolves as follows: normal 'yields' oncogenic HPV infection 'yields' precancer 'yields' invasive cancer. The majority of women with oncogenic HPV infections will not develop cancer, and most HPV infections, even those with associated cellular changes, regress in 1-2 years, probably eradicated or controlled by cellular immune response. Morevoer, while invasive cancer and precancer are histologically welldefined, the histological classification of low-grade lesions, now better defined as HPV infection, is very heterogeneous and poorly reproducible. Identifying women at highest risk for cancer prior to neoplastic progression is therefore a challenge. At present, we are unable to predict with any accuracy which HPV infections will progress and which are among the majority that regress. Currently, cytologic, histologic, and to some extent, HPV DNA assays are the basis for triage, treatment, and follow-up. While this approach has permitted successful cervical cancer prevention efforts, millions of women are diagnosed each year with HPV infections, and because of the inability to distinguish those who will progress from those who will regress, many women are over-treated as a result. It is therefore of etiologic interest and of public health benefit to develop a method for identifying the HPV-infected women at risk for progressing to precancer and invasion. To develop an accurate and reproducible division of precursor lesions (HPV infection and precancer) will require gaining knowledge about the molecular distinctions at each progressive disease state. Our goal is to therefore comprehensively assess biomarkers of risk for progressive cervical neoplasia, and thus develop a new set of biomarkers that can distinguish those at highest risk of cervical cancer from those with benign infection. Specifically, we will initially implement a cross-sectional study to develop a comprehensive list of potential risk biomarkers by examining cervical tissues of women with normal, HPV infection, precancer, and cancer. They will measure gene expression profiles to gain an accurate and comprehensive in vivo picture of cervical neoplasia carcinogenesis. We propose to then validate the most promising identified candidate biomarkers in a prospective design by assessing their predictive values for key outcomes related to progression (HPV persistence, diagnosis of precancer) or non-progression (HPV clearance). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00339989
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase
Start date September 12, 2003
Completion date March 11, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT06223308 - A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Terminated NCT03367871 - Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer Phase 2
Active, not recruiting NCT04537156 - Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli) Phase 3
Recruiting NCT03668639 - Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin Phase 2/Phase 3
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Withdrawn NCT04806945 - A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer Phase 3
Active, not recruiting NCT04185389 - Long-Term Follow-Up of HPV FOCAL Participants
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Completed NCT05120167 - Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy N/A
Recruiting NCT05483491 - KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer Phase 1
Recruiting NCT05736588 - Elimisha HPV (Human Papillomavirus) N/A
Completed NCT05862844 - Promise Women Project N/A
Recruiting NCT04934982 - Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2) N/A
Recruiting NCT03876860 - An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis N/A
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Completed NCT00543543 - Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) Phase 3
Terminated NCT04864782 - QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer Phase 2/Phase 3
Recruiting NCT04226313 - Self-sampling for Non-attenders to Cervical Cancer Screening N/A