Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443313
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2007-03-02
Brief Title:
Human Papillomavirus HPV Testing to Improve Cervical Cancer Screening in the Mississippi Delta
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
HPV Testing to Improve Cervical Cancer Screening in the Mississippi Delta Mississippi Delta Project
Status:
COMPLETED
Status Verified Date:
2015-06-25
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:
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
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
Detailed Description:
Background Cytology screening programs have effectively reduced cervical cancer incidence and mortality in the US by greater than 75 However these programs requiring repeated clinician-administered Pap smears do not adequately cover medically-underserved populations Based partly on HREBDCEG etiologic research we now know that carcinogenic types of human papillomavirus HPV cause virtually all cases of cervical cancer Supported by our translational work with DCP HPV DNA testing is already approved by the FDA as an adjunctive screening modality to cytology in this country and as a primary screening modality to cytology in this country and as a primary screening modality internationally A validated screening program of HPV DNA testing of self-collected cervicovaginal specimens would permit wider coverage screening than cytology in the populations underserved by cytology-based testing like the Mississippi Delta region
Objective To assess the technical feasibility ie non-inferiority or equivalence to cytology for detection of cervical precancer and cancer of cervical cancer screening based on self-collection and HPV DNA testing of cervicovaginal specimens from women aged greater than or equal to 30 years old who live in the Mississippi Delta
Methods One thousand women will be enrolled during 18 months including 500 attending colposcopy due to cytologic abnormality 250 women who regularly attend a screening clinic and 250 unscreened women who have not had a Pap smear within the last 3 years according to current screening guidelines but recruited to attend a screening Three clinical specimens will be collected from each woman A cervicovaginal specimen for HPV testing and a cervical specimen for cytology and HPV testing will be collected from each woman by the physician At the time of the clinic visit women will be give a kit for self-collection of a second cervicovaginal specimen for HPV testing to be returned by mail within two weeks All three specimens from each woman will be tested by two clinical DNA tests that use pooled-probes for detection of carcinogenic HPV an FDA-approved signal amplification test Hybrid Capture 2 from Digene and a new DNA amplification test AMPLICOR from Roche currently in clinical trials Specimens will also be tested retrospectively by a research PCR asay that detects 37 HPV types which will help us evaluate the performance of the two clinical HPV tests Women attending their screening visit who test positive by cytology atypical squamous cells of undetermined significance or worse or for carcinogenic HPV will be referred to colposcopy along with a random sample of HPV negative cytologic negative women n equals 100
Analysis We will compare the clinical performance of HPV DNA testing of self-collected specimens to that of cytology at a threshold of atypical squamous cells of unknown significance ASCUS or more severe for detection of histologically confirmed cervical intraepithelial neoplasia grade 2 CIN2 or more severe greater than or equal to CIN2 Cytology results will be based on standard-of-care cytology screening for women attending the screening visit and repeat cytology for women attending colposcopy An estimated 150 cases of greater than or equal to CIN2 will be identified This is an equivalence study where we wish to reject the null hypothesis that HPV self-testing is greater than 10 less sensitive than cytology Assuming cytology has a 75 sensitivity for greater than or equal to CIN2 a sample size of 150 subjects has 84 power alpha005 one-sided non-inferiority or equivalence test of correlated proportions to rule out a 10 decrement in sensitivity for self-collection with HPV DNA testing compared with cytology will guide whether the new technique could be broadly introduced for cervical cancer screening
Objective To assess the technical feasibility ie non-inferiority or equivalence to cytology for detection of cervical precancer and cancer of cervical cancer screening based on self-collection and HPV DNA testing of cervicovaginal specimens from women aged greater than or equal to 30 years old who live in the Mississippi Delta
Methods One thousand women will be enrolled during 18 months including 500 attending colposcopy due to cytologic abnormality 250 women who regularly attend a screening clinic and 250 unscreened women who have not had a Pap smear within the last 3 years according to current screening guidelines but recruited to attend a screening Three clinical specimens will be collected from each woman A cervicovaginal specimen for HPV testing and a cervical specimen for cytology and HPV testing will be collected from each woman by the physician At the time of the clinic visit women will be give a kit for self-collection of a second cervicovaginal specimen for HPV testing to be returned by mail within two weeks All three specimens from each woman will be tested by two clinical DNA tests that use pooled-probes for detection of carcinogenic HPV an FDA-approved signal amplification test Hybrid Capture 2 from Digene and a new DNA amplification test AMPLICOR from Roche currently in clinical trials Specimens will also be tested retrospectively by a research PCR asay that detects 37 HPV types which will help us evaluate the performance of the two clinical HPV tests Women attending their screening visit who test positive by cytology atypical squamous cells of undetermined significance or worse or for carcinogenic HPV will be referred to colposcopy along with a random sample of HPV negative cytologic negative women n equals 100
Analysis We will compare the clinical performance of HPV DNA testing of self-collected specimens to that of cytology at a threshold of atypical squamous cells of unknown significance ASCUS or more severe for detection of histologically confirmed cervical intraepithelial neoplasia grade 2 CIN2 or more severe greater than or equal to CIN2 Cytology results will be based on standard-of-care cytology screening for women attending the screening visit and repeat cytology for women attending colposcopy An estimated 150 cases of greater than or equal to CIN2 will be identified This is an equivalence study where we wish to reject the null hypothesis that HPV self-testing is greater than 10 less sensitive than cytology Assuming cytology has a 75 sensitivity for greater than or equal to CIN2 a sample size of 150 subjects has 84 power alpha005 one-sided non-inferiority or equivalence test of correlated proportions to rule out a 10 decrement in sensitivity for self-collection with HPV DNA testing compared with cytology will guide whether the new technique could be broadly introduced for cervical cancer screening
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 |
|---|---|---|---|
| 07-C-N080 | None | None | None |