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  • Prevalence of Abnormal Pap Smear

    This study aims to evaluate prevalence of abnormal Pap smear among sexually active women of reproductive age attending Sohag university hospital outpatient clinic. Participating women will be subjected to accurate history taking regarding age, parity, Body mass index, contraceptive use, menstrual history, and duration of marital life, frequency of previous marriages if any, and the status of cervix by per-vaginal examination of the patients. The patient put in dorsal lithotomy position and place the feet in stirrups or on foot rests . then, the physician will insert a cusco speculum into the vagina to hold vaginal wall open . The specimens will be collected as follows; firstly, the speculum will be inserted without lubricant. Any mucous, discharge or blood will be removed with dry cotton. A wooden spatula will be used for sampling ectocervix which will be rotated 360 degrees. For sampling endocervix, A brush or a swab will be rotated only 90 degrees as the circumferential bristles will be in contact with the entire surface the moment the brush is inserted. The samples will be applied to the slides which will be encoded and immediately fixed in 95% ethanol and the samples will be transferred to pathology department to be stained by the standard Papanicolaou stain . The Bethesda System will be used for cytological interpretation.

    Phase

    N/A

    Span

    26 weeks

    Sponsor

    Sohag University

    Recruiting

    Healthy Volunteers

  • Longitudinal HPV Pap in CIN and VAIN

    The long-term outcomes of patients with antecedent cervical intraepithelial neoplasia (CIN) were lacking. A systematic review published in 2008 identified no studies that met the review eligibility criteria for the prevalence of HPV types among vaginal precursors and cancers. Two sporadic studies containing 16 and 81 cases were reported in that review. Given that vaginal intraepithelial neoplasia (VAIN) post-hysterectomy for CIN is an uncommon disease which has a prevalence of being 1 to 6 %; it has the potential to progress to malignancy. Although the etiology of VAIN has not been as thoroughly investigated as that of CIN, evidence implicates that the human papillomavirus (HPV) as the probable carcinogenic agent for the onset and evolution of some VAIN and vaginal cancers. This study will construct a longitudinal risk model of VaIN according to the HPVs distribution of cervix and vaginal for those had CIN2+.

    Phase

    N/A

    Span

    366 weeks

    Sponsor

    Chang Gung Memorial Hospital

    Recruiting

  • Self-Collection of the Pap Smear as Agency: A Novel Way to Improve Refractory Low Cervical Cancer Screening Rates in Rural Alabama

    Papanicolaou (Pap) smears will be both self-obtained by the patient and obtained by a licensed physician, nurse practitioner, or physician assistant. Specimens will then be collected by the nurse or medical assistant who will label each specimen separately. Specimens will be blinded so that the pathologist will not know which specimen was self-collected and which provider-collected. Specimens will then be sent to our clinical laboratory provider (LabCorp) for analysis. Once results from the Pap smears are received, participants will be notified in the usual manner in our clinical practice. Finally, analysis will be conducted to ascertain whether or not a self-administered (by the patient) Pap smear is as accurate as a traditional Pap smear administered by a healthcare provider.

    Phase

    N/A

    Span

    271 weeks

    Sponsor

    University of Alabama at Birmingham

    Recruiting

  • Determine the Utility of Liquid Biopsies and Tumor Molecular Profiling in Predicting Recurrence in Endometrial Cancers

    PRIMARY OBJECTIVES: I. Compare TP53, FBXW7, and other mutated gene variant allele frequencies (VAF) in serial circulating cell free deoxyribonucleic acid (ccfDNA) samples obtained from patients with endometrial cancer subtypes during the primary treatment course, which may include pretreatment, post-surgical removal, post adjuvant treatment, and at time of recurrence. II. Compare the findings from the liquid biopsy mutational analysis to next generation sequencing from the primary tumor. EXPLORATORY OBJECTIVES: I. To estimate the presence of malignant cells in the vagina before and after minimally invasive hysterectomy among patients with endometrial cancer. II. Characterize the immune profile and single cell ribonucleic acid (RNA) sequencing (scRNAseq) profile of endometrial cancer subtypes. III. Estimate time to progression (TTP), and investigate potential correlations between mutated gene variant allele frequency (VAF) ccfDNA samples and progression. IV. Compare the efficacy of experimental ccfDNA assays to approved ccfDNA assay using the same samples. OUTLINE: Patients undergo collection of blood samples for liquid biopsy during pre-treatment consultation before hysterectomy, after hysterectomy but before starting any chemotherapy, and at the end of last chemotherapy cycle. Patients also undergo collection of tissue samples during hysterectomy. Patients may also undergo Pap smears before and after hysterectomy.

    Phase

    N/A

    Span

    472 weeks

    Sponsor

    M.D. Anderson Cancer Center

    Recruiting

  • Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.

    Phase

    N/A

    Span

    257 weeks

    Sponsor

    Dr. Danielle Vicus

    Recruiting

    Healthy Volunteers

  • 102 Annual Pap Smear Screening Database Maintenance Project

    Phase

    N/A

    Span

    Sponsor

    National Taiwan University Hospital

    Recruiting

    Healthy Volunteers

  • Prevalence and Clinical Implications of HPV Infection in Male IBD Patients

    Male IBD patients attending the IBD Clinic of Hospital de la Santa Creu i Sant Pau will be screened for eligibility. Informed consent will be obtained from all eligible patients. An anal and oral swab will be performed on all patients to look for HPV infection (HPV DNA test) and cytologic alterations. Patients will be inspected to rule out the presence of HPV-related lesions. Moreover, a self-administered questionnaire will be completed by all enrolled patients. Information regarding IBD characteristics and treatment will be obtained. According to local practice, patients with anal or oral squamous intraepithelial lesions (ASIL) will be referred to a colorectal surgeon for further recommendations or treatment.

    Phase

    N/A

    Span

    120 weeks

    Sponsor

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    Recruiting

  • The Effect Of Virtual Reality Glasses Applied During Pap Smear On Anxiety, Pain And Patient Satisfaction

    Cervical cancer is the most important preventable gynecological cancer that can be diagnosed with early screening among female gynecological cancers. Today, cervical cancer has become an important public health problem (General Directorate of Public According to the data of the Global Cancer Observatory (GLOBOCAN), a subsidiary of the World Health Organization, 604,127 women were diagnosed with cervical cancer in 2020. With these new cases, cervical cancer ranked 4th worldwide in incidence and mortality. In Turkey, the incidence of cervical cancer ranks 3rd among gynecological cancers. In the world and in Turkey. The primary prevention of this cancer type, which has a high mortality rate in addition to its incidence rate, is the Human Papilloma Virus (HPV) vaccine. Secondary prevention includes early diagnosis with screening tests. Screening tests for the diagnosis of cervical cancer are pap smear test and HPV DNA test. Thanks to the Pap smear screening test, the diagnosis can be made even if cervical cancer does not show any symptoms. In addition, preinvasive and invasive lesions of cervical cancer can be detected. Thanks to these features of the Pap smear test, lesions can be detected in the early period, the treatment process can be started early, and mortality and morbidity rates can be reduced. The Pap smear test is an easy-to-apply, inexpensive, reliable and easy-to-access screening test. It has been reported that regular pap smear test screening reduces the mortality and morbidity rate of cervical cancer by 70% in developed countries. It is recommended by the Ministry of Health that women over the age of 30 should have a pap smear test once every 5 years. It is recommended that screening be discontinued in women who have 3 consecutive negative tests or who are over 65 years old. Despite the recommendations and practices of the Ministry of Health, 20% of women in Turkey were screened within the scope of the screening program. Studies conducted in the national and international literature reveal many reasons why women do not have a pap smear test. The primary reason why women do not have a pap smear test is gynecological examination. Women may experience anxiety and worry due to the speculum used during the gynecological examination, the fact that the procedure area is a private area, and the possibility of being diagnosed with cancer as a result of the test. In a study, it was found that 20.7% of women experienced moderate anxiety and 10.9% had high level anxiety before the gynecological examination. In another study, the state anxiety score of women who applied for a pap smear test was found to be high. Women may develop negative attitudes towards screening tests due to the anxiety they experience. For this reason, early diagnosis may miss the opportunity. Özcan et al. recommend that nurses provide supportive care to women during gynecological examination and reduce their anxiety. Distraction method and pain and anxiety management are among the independent roles of nurses. There are many nursing practices that can be done to reduce the anxiety and pain feelings of patients. Virtual reality application is also used as one of these applications. With the developing technology, virtual reality applications have started to be applied as a distraction technique. Created as a result of combining three-dimensional and interactive graphics prepared in virtual reality computer environments with various programs in the computer environment, it has been defined as technologies that draw users directly into a virtual world and create the feeling of being in the real world. The sensors placed in the virtual reality glasses detect the head movements of the user and act in sync with the virtual environment, allowing the individual to see the place where the individual turns his head in the virtual environment. Thanks to this feature of virtual reality glasses, people can make nature, underwater and museum tours. Virtual reality glasses create a feeling of being in a virtual environment. Thus, the person can completely move away from the environment. This feature of virtual reality applications is mostly used in the medical field. People are moving away from the medical environment they are in, they feel as if they are in the images being watched. In this way, their attention can be diverted and their anxiety levels can be reduced. As people focus on the images they see, pain signals reach the brain later and there is a decrease in pain sensation. Anxiety and pain can be reduced with virtual reality application during invasive procedures such as hysteroscopy, amniocentesis, curettage, embryo transfer. reduction studies have been carried out. In the study of Deo et al., qualitative interviews were conducted at the end of the virtual reality application. 85% of the participants stated that the virtual reality application removed them from the examination environment, thus they felt less pain and their anxiety decreased. Studies using virtual reality during gynecological and obstetric diagnosis and treatment procedures have been found in the literature. In the available literature, no study has been found in which virtual reality is applied to women who will undergo pap smear test. With this study, it was aimed to increase patient satisfaction by reducing the pain and anxiety experienced during the pap smear screening test. In addition to this purpose, this study is important in terms of showing that virtual reality application, which is a product of developing technology, is adaptable and applicable to nursing care. It is thought that the health worker can also apply the procedure more easily, thanks to the reduction and relaxation of the anxiety of the woman during the procedure. As a result of the study, it is thought that if the pain and anxiety levels of women are reduced, the rates of having pap smear screening test will increase in the long run. In the study of Marashi et al., negative experiences during the first test were shown as one of the reasons why women did not have a pap smear test. It is thought that the negative experiences of women will be minimized by reducing the level of pain and anxiety. It is thought that the results of the research will contribute to the current literature.

    Phase

    N/A

    Span

    55 weeks

    Sponsor

    Duzce University

    Recruiting

    Healthy Volunteers

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