Carbon Nanoparticles and Indocyanine Green for Sentinel Lymph Node Biopsy in Early Stage Cervical...
Cervical Cancer Stage IB1The metastasis rate of pelvic lymph node in early cervical cancer is low. Systemic lymph node resection is traumatic and has many complications. Sentinel lymph node (SLN) biopsy can effectively avoid unnecessary lymph node dissection, which has been recommended in clinical guidelines. Indocyanine green(ICG) fluorescence imaging as the method of SLN mapping is recommended in international guidelines. However, the imaging equipment is very expensive which limits the popularization of ICG in different medical centers of various surgical volumes. Carbon nanoparticle is an innovative tracer without any special imaging equipment for SLN mapping in China. Some retrospective researches have proved that carbon nanoparticle is effective, simple, economic and suitable for popularization in different medical centers. In this study, a prospective randomized controlled trial will be conducted to analyze the non-inferiority of carbon nanoparticles compared to ICG, and to verify the application value of carbon nanoparticles. 144 cervical cancer patients with stage IB1 (FIGO2018) will be prospectively enrolled and randomly divided into two groups (R = 1:1). 72 patients will undergo SLN biopsy with carbon nanoparticles and 72 patients will be mapped by ICG. The primary endpoint is overall SLN detection rate. The secondary endpoints include bilateral SLN detection rate, the number of SLN detected, sensitivity, false negative rate and negative predictive value of SLN biopsy. Diagnostic accuracy will be evaluated at both pelvis and patient levels. What's more, SLN pathological ultrastaging will be conducted to increase the diagnostic accuracy. The hypothesis of this study is that the overall SLN detection rate by carbon nanoparticles is not inferior to that using ICG. And the differences of bilateral SLN detection rate, sensitivity, false negative rate and negative predictive value between two groups are not significant.
Acceptability and Efficacy of Self-sampling for Cervical Cancer Screening: A Pilot Study
Cervical CancerCervical Dysplasia1 moreIn Singapore, the current cervical cancer screening uptake among women in Singapore has remained at low 50% since its introduction in 2004. It has been widely reported that under-screened women have the highest risk of cervical cancer. Self-sampling HPV DNA screening may be a solution to the low uptake rates of local women, particularly among the under-screened population in Singapore. Self-sampling comprises women using a swab to obtain samples from their vagina. In this study, we are comparing the sensitivity of detecting HPV positive women using HPV DNA test with self-sampling using flocked swab with the current physician sampling method. We also aim to determine acceptability of self-sampling HPV DNA test using flocked swab in cervical cancer screening. Designed as a feasibility study, it will comprise a prospective study of 300 women attending clinics in National University Hospital (NUH) and National Cancer Institute Singapore (NCIS).
Smoking Cessation for Cervical Cancer Survivors
Cervical CancerTobacco Use1 moreThe goal of this research study is to compare a program called Motivation And Problem-Solving (MAPS) to the standard treatment to help participants with a history of cervical cancer or high-grade cervical dysplasia quit smoking.
Cisplatin Plus One-Day 24-hour Infusion of High-Dose 5-Fluorouracil for Stage IVB, Recurrent or...
Cervical CancerObjectives: To evaluate the effectiveness and toxicity of the combination of infusional cisplatin and 24-hour infusion of high-dose fluorouracil plus leucovorin (P-HDFL) repeatedly every 21 days for the treatment of stage IVB, recurrent or metastatic carcinoma of cervix. Methods: The medical records of all patients with stage IVB, recurrent or metastatic cervical cancer who were treated with P-HDFL regimen between January 2005 and December 2009 at National Taiwan University Hospital were reviewed. Expected results: Investigators will identify the effectiveness and toxicity of the combination of infusional cisplatin and 24-hour infusion of high-dose fluorouracil plus leucovorin (P-HDFL) repeatedly every 21days for the treatment of stage IVB, recurrent or metastatic carcinoma of cervix.
Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy
Cancer of the CervixCancer of the EndometriumThis is an observational study. The purpose is to determine the feasibility of using a novel nano-scintillator fiber-optic dosimeter (nanoFOD) for the real time dosimetric monitoring of brachytherapy treatment. Women with gynecologic cancers treated with brachytherapy as part of their standard therapeutic regimen will represent the study population.
Cervical Cancer Prevention: From DNA to mRNA? - New Technologies for Cervical Cancer Screening 2...
Precancerous ConditionsNeoplasmsIn industrialized countries, cervical cancer is a well controlled disease thanks to the diffusion of Pap test and, in particular, to organized screening programs, which are able to detect and treat pre-invasive lesions (cervical intraepithelial neoplasia, CIN). The human papilloma virus (HPV) has been recognised as the necessary, but not sufficient, cause of cervical cancer, so a new screening test based on the identification of high risk (HR) HPV types has been developed(HPV DNA test). This test has demonstrated to be more effective than cytology in reducing the incidence and the mortality of cervical cancer, but it is less specific, so the use of a test triage is necessary to reduce the number of colposcopies and the risk of over-diagnosis (due to the potential regressivity of pre-invasive lesions). Until now, the triage test used is the cytology (Pap test). Recently specific biomarkers (mRNA and p16 tests) have been introduced for high grade CIN, targeting the molecular alterations strictly associated to transformation rather than simply detecting HR-HPV infections. These tests are more specific than HPV DNA test with a modest reduction of sensitivity for high-grade lesions. This is a multicenter randomised trial nested into some Italian screening programs based on the use of HPV DNA test as primary test. All women with positive HPV DNA test will be tested for cytology and also for mRNA and p16. Women with positive cytology will be referred to colposcopy, while women with negative cytology will be randomized into two arms. This study aims to evaluate if mRNA and p16 could be used as test of triage of HPV DNA or as a primary screening test with direct sending in colposcopy. In particular the main objectives are: Measuring the cumulative detection rate of CIN2+ in the five years following a HPV DNA positive test and mRNA or p16 negative. Measuring the potential reduction of overdiagnosis of using mRNA or p16 test instead of DNA, with direct sending in colposcopy Measuring the reduction of overdiagnosis of cytological triage or triage with mRNA or p16 compared to the direct sending in colposcopy in women with HPV DNA test positive. Secondary objectives are: to assess the feasibility of mRNA testing in primary screening to validate the sample techniques for the new tests to standardize quality controls for the the new tests
Predicting Outcome in Cervix Carcinoma: a Prospective Study
Cervical CancerThe main aim is to validate and improve the predictive model for survival and toxicity in patients with cervical cancer through multicentric prospective data collection. The data contain information on patient, tumor and treatment characteristics. For this study, additional health related QOL scores will be assessed using the EORTC Quality of Life Questionair-CX24 and C30. The long term aim, beyond this specific study, is to build a Decision Support System based on the predictive model validated in this study.
Carevive Survivor Care Planning System in Improving Quality of Life in Breast Cancer Survivors
Stage I Breast CancerStage I Cervical Cancer37 moreThis pilot clinical trial studies how well the Carevive Survivor Care Planning System works in improving quality of life in breast cancer survivors. A personalized survivor care plan includes a summary of a patient's cancer treatment and a customized survivor care plan and may provide beneficial information and resources.
HRME in the Screening of Cervical Cancer Precursor Lesions in Brazil (UH3 - Brazil)
Intraepithelial NeoplasiaIntraepithelial Neoplasm3 moreSTUDY PURPOSES: This study aims to evaluate a high resolution microendoscope (HRME): 1) To assess the sensitivity and specificity of the HRME device in the detection of cervical intraepithelial neoplasia grade 2 (CIN2) or histologically more severe lesion (NIC2+) and cervical intraepithelial neoplasia grade 3 (CIN3) or histologically more severe lesion (NIC3+) in a comprehensive case-by-case basis; 2) Compare the accuracy of the HRME device with acetic acid visualization (VIA) and colposcopy. METHODOLOGY: 1,780 women with abnormal Pap Smears (ASCUS+) or positive high-risk human papillomavirus (HPV) test in the cervix performed in the Barretos Cancer Hospital (HCB, Barretos, Brazil) screening program will be recruited, either at Mobile Prevention Units or Fixed Units, who have been referred for diagnostic investigation with colposcopy. The invitation for women to participate in the study will be made immediately before the medical consultation for colposcopy, in the Prevention Department of Barretos Cancer Hospital. Women who decide to participate in this study will sign an Informed Consent Form after invitation and relevant explanations, which will be provided by the researcher in charge or by a representative with previous training appointed by him for the application of the Form in question. During the colposcopy examination, the HRME device will be used to check the presence of precursor lesions in the cervix. HRME will capture images from all areas considered abnormal by VIA and/or colposcopy. Any abnormal areas detected by VIA and/or colposcopy will undergo a biopsy. If no abnormal area is observed, a cervical microbiopsy will be obtained from an apparently normal area examined using HRME. If during the study a precursor disease or cervical cancer is detected in any woman, an appropriate treatment will be offered by Barretos Cancer Hospital according to an institutional protocol.
TMVP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer
Cervical CancerSentinel lymph node (SLN) mapping is an acceptable surgical strategy determine whether to perform radical lymphadenectomy in patients with early-stage cervical cancer. Investigators aim to determine the validity of this technique with our novel tumor targeted fluorescent TMVP1-ICG to increased accuracy of SLN mapping.