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Uterine Cervical Neoplasms clinical trials

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NCT ID: NCT02273206 Completed - Depression Clinical Trials

Collaborative Care to Reduce Depression and Increase Cancer Screening Among Low-Income Urban Women

PCM3
Start date: January 2014
Phase: N/A
Study type: Interventional

Bronx County, New York is the poorest urban county in the U.S.A., and residents are almost entirely Latino or African American. Cancer is the leading cause of premature death in the Bronx, with morality rates significantly higher than for New York City as a whole. Low-income/minority populations are more likely to be diagnosed with preventable and late-stage cancers than the general population, in part, due to lower screening rates. While research has addressed screening barriers in low-income/minority groups, depression, a common,potentially critical barrier, has received scant attention. Research suggests that depressed women are less likely to engage in cancer screening, especially mammography and Pap testing. The link between mental health and cancer screening is particularly important to address in the Bronx, which has the highest rates of self-reported serious psychological distress (a measure closely related to depression) in New York City. Depression affects almost 1 in 4 minority women, and while minorities often seek help for depression in primary care, primary care depression management often does not meet evidence-based standards. Drawing on the expertise and close collaboration of Bronx medical and social service providers and patient stakeholders, this study will determine whether a collaborative care intervention that addresses both depression and cancer screening needs simultaneously among women ages 50-64 is more effective at improving cancer screening and patient-reported outcomes for women with depression than an existing evidence-based cancer screening intervention alone. To achieve this, the investigators will compare the effectiveness of these two interventions using a randomized controlled trial (RCT). In partnership with six Bronx Federally Qualified Health Centers (FQHCs), the investigators will recruit approximately 800 women ages 50-64 who screen positive for depression and are non-adherent with recommended cervical, breast, and/or colorectal cancer screenings. The investigators specific aims are to: 1) compare the impact of the two interventions on patient-reported outcomes, including cancer screening knowledge and attitudes, self-efficacy, depression-related stigma, provider referrals, participation in mental health care, medication adherence, quality of life, satisfaction with care and treatment decisions, and depression; 2) compare the effectiveness of the two interventions in increasing breast, cervical, and colorectal cancer screening; 3) determine whether reducing depression increases the likelihood that low-income women 50-64 will receive cancer screening; 4) determine whether effectiveness of the two interventions in increasing cancer screening varies according to patient characteristics, such as duration of depression, presence of other chronic conditions, and obesity. This study is designed to increase the investigators understanding of how to enhance primary care systems' ability to improve a range of outcomes related to cancer screening and depression among low-income minority women, and how to best support this population in making cancer-screening decisions.

NCT ID: NCT02272075 Completed - Cervical Cancer Clinical Trials

SmartScope vs Standard Colposcope for the Evaluation of Cervical Dysplasia

Start date: November 2014
Phase: N/A
Study type: Interventional

This trial will compare images obtained from a mobile colposcope with those obtained using a standard of care.

NCT ID: NCT02270021 Completed - Cervical Cancer Clinical Trials

Decreasing Over Screening and Treatment of Cervical Precancers in Young Women

Start date: July 24, 2014
Phase: N/A
Study type: Interventional

The goal of this study is to prevent over screening and over treatment of young women for cervical precancers, which can result in psychological distress and has been associated with future risk of premature deliveries. Current national guidelines recommend that routine screening be performed at less-frequent intervals and that excisional cervical therapies are discouraged in young women. The objectives of this study are to examine physician- and patient-based interventions designed to decrease over screening and over treatment by increasing adherence to US guidelines for women under 30 years.

NCT ID: NCT02267876 Completed - Clinical trials for Human Papillomavirus

Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens

Start date: October 2014
Phase:
Study type: Observational

The purpose of the study is to assess the cumulative disease detection of greater than or equal to Cervical intraepithelial neoplasia 2 (CIN2) and greater than or equal to Cervical intraepithelial neoplasia 3 (CIN3) in the subjects over 3 years using the subject's HPV status and cytology status from the BDS-USHPV baseline results

NCT ID: NCT02265120 Completed - Cervical Cancer Clinical Trials

Primary Care Providers' Views and Understanding of Current Recommended Guidelines for Cervical Cancer Screening

Start date: October 2014
Phase: N/A
Study type: Interventional

Significant developments have led to a dramatic change in recommendations for cervical cancer screening. The understanding that the Human Papilloma Virus (HPV) is the cause of nearly 100% of cervical cancer cases and the development of new technologies for detection of HPV DNA at time of cervical cancer screening, has produced changes in preventive healthcare policy for this condition. In an unprecedented event, the American College of Obstetrics and Gynecology, the American Cancer Society and the U.S. Preventive Services Task Force recommended dramatic and unified changes in screening utilizing this new framework. No studies of significance have evaluated (since guideline change in 2013), whether primary care providers find the new recommendations authoritative and believe in them, or whether providers understand implementation of these new guidelines given the many decades of contradictory and differing recommendations. For this study, the opinions of primary care providers who care for patients in the 194 federally designated regions of Primary Care provider shortage within California will be studied. Using the California Medical Board database of licensed providers, a questionnaire will be mailed to a random subset. It is anticipated that the analysis will show varying contempt, confusion and compliance with new guidelines exists. Understanding these factors will have beneficial health policy implications in terms of overcoming barriers to these cost-effective, less intrusive, and more accurate health policy guidelines in the prevention and early detection of cervical cancer.

NCT ID: NCT02257528 Active, not recruiting - Clinical trials for Cervical Adenocarcinoma

Nivolumab in Treating Patients With Persistent, Recurrent, or Metastatic Cervical Cancer

Start date: May 18, 2015
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects and how well nivolumab works in treating patients with cervical cancer that has grown, come back, or spread to other places in the body. Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain cells.

NCT ID: NCT02253719 Completed - Cervical Cancer Clinical Trials

Cervical Cancer Screening in HIV Positive and Negative Women in Cambodia

Start date: October 2014
Phase: N/A
Study type: Observational

The prevalence of cervical neoplasia in Cambodia is not known. There are no screening programs in place. The investigators plan on introducing a screening program based on WHO criteria and utilizing visualization with acetic acid. Patients who are positive will be offered same-day cryotherapy if indicated or will be referred for biopsy, LEEP and hysterectomy as indicated. The planned patient pool for this study is 1000 women, half of whom will be HIV positive (and thus have a presumed higher incidence of cervical neoplasia).

NCT ID: NCT02247999 Completed - Cervical Cancer Clinical Trials

Improving Cervical Cancer Screening Among HIV-Infected Women in India

Start date: November 28, 2012
Phase:
Study type: Observational

Background: - Cervical cancer is a major cause of cancer deaths among women. Most cases of cervical cancer are caused by the human papillomavirus (HPV). HPV is more common in women who have the human immunodeficiency virus (HIV). India has one of the highest rates of women who have both cervical cancer and HIV infection. - Cervical cancer can be discovered in early stages by screening for HPV infection. Researchers want to compare new cervical cancer screening tests for HIV-infected women. They also want to know more about how HPV can lead to cervical cancer in HIV-infected women. To do so, they will hold a study to screen HIV-infected women in India. Objectives: - To improve cervical cancer screening methods in HIV-infected women in India. Eligibility: - Women at least 18 years of age who have HIV infection. - Participants will be recruited from HIV-focused health care clinics in Pune and Chennai, India. Design: - Participants will have a physical exam and medical history. They will provide a urine sample and proof of HIV infection. - Participants will have a gynecological exam. This will involve a pelvic exam and Pap smear to collect cells for study. It will also involve a cervical exam to look for precancerous cells. Cervical tissue may be collected. - Participants will also provide a blood sample for testing. - Participants will return in 2 weeks for the test results. If there are signs of precancerous or cancer cells, participants will be referred to a doctor for treatment.

NCT ID: NCT02247232 Completed - Cervical Cancer Clinical Trials

Randomized Study of Z-100 Plus Radiation Therapy to Treat Cervical Cancer

Start date: December 2014
Phase: Phase 3
Study type: Interventional

This study is a phase III, multicenter, double-blind, placebo-controlled, parallel group comparative study to evaluate the efficacy and safety of Z-100 with primary uterine cervical cancer on radiotherapy. The study will use a central randomization with a dynamic allocation using biased coin minimization.

NCT ID: NCT02238990 Active, not recruiting - Clinical trials for Evaluation of New Tissue Biomarkers for Cervical Cancer

Biomarkerscreening in Cervical Cancer and Its Preinvasive Lesions

Start date: September 2014
Phase:
Study type: Observational

The following trial is a multicenter and prospective research trial of the colposcopy unit of luebeck university and the national research center in Borstel, Germany. The study is to identify and evaluate new biomarkers in human papilloma virus (HPV) associated malignancies and its preinvasive lesions of the cervix uteri. Fresh tissue samples being removed during conizations and/or hysterectomies are to be fixed in HOPE's solution and analyzed according to their transcriptomes and methylosome. The hereby found candidates are to be validated using immunohistochemistry and RT [real-time] -PCR [polymerase chain reaction]. The project is meant to be followed by continuous studies developing a new test describing the malignant potential of HPV associated genital lesions.