Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339989
Status:
COMPLETED
Last Update Posted:
2020-03-13
First Post:
2006-06-19
Brief Title:
Cervical Cancer Early Endpoints and Determinants
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Study to Understand Cervical Cancer Early Endpoints and Determinants SUCCEED
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-C-N302 | None | None | None |