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- The Mississippi Delta (which includes the counties along the Mississippi River) is one of the poorest areas in the United States. Women living in the Mississippi Delta have disproportionately high rates of cervical cancer, but they are unlikely to come to clinics except perhaps for giving birth, years before they are diagnosed with cancer.
- To improve rates of screening, researchers are attempting an outreach study to see whether under-screened women, if approached by door-to-door recruitment, would get screened by one of two methods (home-based self-collection and testing, or a clinic exam) and which method they would prefer.
- To assess/measure increased participation of under-screened women living in the Mississippi Delta in cervical cancer screening by offering women the opportunity to get screened by one of two possible community outreach-based cervical cancer screening modalities, self-collection and HPV testing or clinic-based cytology screening, the current standard of care.
- Women between 26 and 65 years of age, who are not pregnant currently or in the past 8 weeks, have an intact cervix, have no history of cancer, and have not been screened for cervical cancer in the past 3 years.
- Researchers will recruit participants on a door-to-door basis. Researchers will recruit all eligible women within a household. Recruitment will be done only during daylight hours but at the end of the working day to maximize the chances of finding women at home.
- Eligible women willing to participate will complete a questionnaire with demographic and medical information.
- Participants will be asked to choose the screening method of their preference. If they choose self-collection with HPV testing, they will be given a self-collection kit and asked to perform the self-collection and return the kit within 1 month. Participants who choose to have cytology screening will be provided with the phone number and location of the local health department clinic and will be encouraged to schedule their screening within the following month.
- Women who do not complete their participation within 1 month will be considered noncompliant with their chosen intervention. Researchers will re-contact noncompliant women to offer them participation in the study, including permitting them to refuse to participate or to choose the alternative intervention.
We have been conducting a study of self-collected cervicovaginal specimens and carcinogenic human papillomavirus (HPV) DNA testing for cervical cancer screening of women living in the Mississippi Delta, who have disproportionately high rates of cervical cancer. To date, we have noted high levels of participation as well as high percentages of completion and return of the home self-collection. Although we have recruited some under-screened women into our study, it was clinic-based (i.e., under-screened women were still required to come to the health department clinic), using Mississippi State Department of Health district clinics. In reality, women who get cervical cancer in the Mississippi Delta are unlikely to come to clinics except perhaps for giving birth, years before they are diagnosed with cancer. Thus, as an ancillary study to our work in Mississippi, we are proposing an outreach study to determine whether under-screened women, if approached via door-to-door recruitment, would participate (get screened) by one of two community outreach-based cervical cancer screening modalities, home-based self-collection and HPV testing or clinic-based cytology screening, and which of the two modalities they prefer. We will recruit door-to-door 400 under-screened, eligible women aged 26-65 years living in the Mississippi Delta. Consenting, eligible women will be given a choice of taking and using a self-collection kit on their own or coming to the local Health Department clinic for cervical cytology screening. Under the assumption that only 5% of this under-screened population would choose to undergo screening without intervention, recruitment of 400 women into the study will permit us to detect a 2-fold increase in participation in screening (defined as completing screening) with 90% power (alpha = 0.05). In this scenario, we will be able to detect with 90% power (alpha = 0.05) a 25% preference for one of the screening methods (75% vs. 50% (no preference)).
Time Perspective: Prospective
Cervical Intraepithelial Neoplasia
University of Alabama
National Institutes of Health Clinical Center (CC)
Published on BioPortfolio: 2014-08-27T03:16:20-0400
The present primary therapy of cervical intraepithelial neoplasia (CIN) grade 3 and persistent CIN 2 represents conisation. Surgical treatment can cause perioperative (infection, bleeding ...
This randomized phase II trial studies how well cyclophosphamide and IRX-2 work in treating women with cervical squamous intraepithelial neoplasia 3 or squamous vulvar intraepithelial neop...
This is a Phase 2, open-label, dose-rising study evaluating the safety, tolerability, and preliminary efficacy of three concentrations of SOR007 ointment (0.15%, 1.0%, and 2.0%) applied to...
RATIONALE: Chemoprevention is the use of certain drugs to keep tumors from forming, growing, or coming back. Zoledronate may prevent the growth of cervical cancer by blocking blood flow to...
RATIONALE: Diagnostic procedures, such as digital colposcopy, may help doctors find and diagnose cervical intraepithelial neoplasia. PURPOSE: This clinical trial is studying digital colpo...
Protein 16 (p16) and transforming growth factor-beta 1 (TGF- β1) are important tumor suppressor molecules. The aim of this study was to evaluate the frequency and simultaneous expression of p16 and T...
To explore the effect of vaginal micro-environment alterations and HPV16 infection and their interaction in the progression of cervical intraepithelial neoplasia. The participants of this study came ...
To identify factors for predicting residual or recurrent cervical intraepithelial neoplasia (CIN) after cervical conization with negative margins.
To assess if women living with HIV (WLWH) have poorer outcome after treatment of cervical intraepithelial neoplasia (CIN2+) than HIV-negative women and to identify predictors of CIN2+ treatment failur...
Self-sampling to test for high risk human papilloma virus (HPV) is becoming an increasingly important component of cervical cancer screening. The aim of this observational study is to examine how wome...
Morphological abnormalities of the cervical EPITHELIUM, usually revealed in PAP SMEAR, which do not meet the criteria for squamous CERVICAL INTRAEPITHELIAL NEOPLASIA or SQUAMOUS CELL CARCINOMAS of the CERVIX . It may be a sign of infection with certain types of human papillomavirus (HPV).or sign of a benign (not cancer) growth, such as a cyst or polyp or, in menopausal women, of low hormone levels. More testing, such as HPV test, may be needed.
A malignancy arising in uterine cervical epithelium and confined thereto, representing a continuum of histological changes ranging from well-differentiated CIN 1 (formerly, mild dysplasia) to severe dysplasia/carcinoma in situ, CIN 3. The lesion arises at the squamocolumnar cell junction at the transformation zone of the endocervical canal, with a variable tendency to develop invasive epidermoid carcinoma, a tendency that is enhanced by concomitant human papillomaviral infection. (Segen, Dictionary of Modern Medicine, 1992)
A premalignant change arising in the prostatic epithelium, regarded as the most important and most likely precursor of prostatic adenocarcinoma. The neoplasia takes the form of an intra-acinar or ductal proliferation of secretory cells with unequivocal nuclear anaplasia, which corresponds to nuclear grade 2 and 3 invasive prostate cancer.
A cytological test finding often from PAP SMEARS that shows abnormal lesions of SQUAMOUS EPITHELIAL CELLS of the CERVIX. It is a diagnostic criterion used in the Bethesda System for UTERINE CERVICAL NEOPLASMS and represents the PAP TEST result that is abnormal. Although squamous intraepithelial lesions test result does not mean UTERINE CERVICAL NEOPLASMS it requires follow-ups (e.g., HPV DNA TESTS; and COLPOSCOPY).
A network of nerve fibers originating in the upper four cervical spinal cord segments. The cervical plexus distributes cutaneous nerves to parts of the neck, shoulders, and back of the head, and motor fibers to muscles of the cervical spinal column, infrahyoid muscles, and the diaphragm.
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Cervical cancer is a malignant neoplasm of the cervix uteri or cervical area. Symptoms include vaginal bleeding, but may not present until later stages of the cancer. Cervical cancer can be treated using surgery (including local excision) in early stages...
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...