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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA111187 | U.S. NIH Grant/Contract | View source | |
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| UWCC-6113 | Other Identifier | Fred Hutchinson/University of Washington Cancer Consortium | |
| UWCC-04-4928-B01 | Other Identifier | Fred Hutchinson/University of Washington Cancer Consortium | |
| FHCRC-6113 | Other Identifier | Fred Hutchinson/University of Washington Cancer Consortium | |
| CDR0000482330 | Registry Identifier | PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE: This is a longitudinal, multicenter study.
Patients undergo biopsy for removal of cervical tissue. Patients also undergo blood and urine sample collection. Samples are analyzed for the presence of cancer or changes that indicate that cancer might develop. Patients also undergo colposcopy at baseline and at 3 years.
After completion of study procedures, patients are followed every 4 months for up to 3 years.
PROJECTED ACCRUAL: A total of 1,150 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV+, <CIN2 | HIV positive women without CIN2-3 or worse | ||
| HIV-, no >=CIN3 biopsy, HR HPV+ | HIV negative women without biopsy-proven CIN3 or worse, and with high risk HPV infection | ||
| HIV-, <=CIN1, HPV- at screening | HIV negative women who are <= CIN1 and HPV negative at screening |
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| Measure | Description | Time Frame |
|---|---|---|
| Identification of hypermethylated genes that are predictive of cervical intraepithelial neoplasia (CIN) grade 3 or invasive cervical cancer | Use molecular assays to identify a panel of hypermethylated genes that are predictive of CIN-3/ICC among women with and without HIV infection. We will rank genes by their ability to discriminate normal cervical tissue from CIN-3/ICC after stratifying by HIV infection. | 3 years |
| Assessment of the risk of developing CIN3 in relationship to human papillomavirus (HPV) persistence, HIV, and the presence or acquisition of candidate hypermethylated genes | Perform a nested case control study assessing the risk of developing CIN-3 in relationship to HPV persistence, HIV, and the presence or acquisition of the candidate hypermethylated genes. | 3 years |
| Identification of HIV-related factors associated with the presence or acquisition of specific hypermethylated genes | Identify HIV-related factors (CD4 counts, viral load, HAART) which might be associated with the presence or acquisition of specific hypermethylated genes. | 3 years |
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INCLUSION CRITERIA:
Underwent Pap smear, human papillomavirus (HPV) testing, and HIV testing AND meets any of the following criteria:
Biopsy and colposcopy confirmed cervical intraepithelial neoplasia (CIN) or invasive cervical cancer (ICC), meeting any of the following criteria:
HIV seropositive
Negative cytology but positive for high-risk human papillomavirus (HPV)
Negative cytology and negative HPV
HIV negative (without biopsy-proven CIN 3 or worse) and high-risk HPV infection (types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 55, 56, 58, 59, 68, 82, 83, 73)
>= 18 years of age
Intact cervix
Not pregnant
Able to provide informed consent
EXCLUSION CRITERIA:
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All study participants will be African women presenting to the clinical sites in Dakar, Senegal. Subjects will be representative of ethnic and racial groups living in Senegal.
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| Name | Affiliation | Role |
|---|---|---|
| Nancy B. Kiviat, MD | Harborview Injury Prevention and Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universite De Fann | Dakar | BP 5035 | Senegal | |||
| Hopital Aristide Le Dantec |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D011230 | Precancerous Conditions |
| D065309 | Atypical Squamous Cells of the Cervix |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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Cervical brush in PreservCyt, cervical swab in STM, cervical swab in Roche media, whole blood, void urine, cervical tissue biopsy.
| Dakar |
| BP 5126 |
| Senegal |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |