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Carcinoma in Situ clinical trials

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NCT ID: NCT02039388 Completed - Ovarian Cancer Clinical Trials

Lavage of the Uterine Cavity for the Diagnosis of Serous Tubal Intraepithelial Carcinoma

LUSTIC
Start date: November 2013
Phase: N/A
Study type: Interventional

The current study aims at answering the scientific question, whether exfoliated cells from STICs get transported into the uterine cavity via the fallopian tube, and whether it is possible to detect those cells in the lavage fluid from the uterine cavity and proximal fallopian tubes. To address this question, the investigators will study 20 lavage samples and their 20 corresponding STIC-positive tissue samples in women who opt for risk-reducing bilateral salpingo-oophorectomy (rrBSO) because of increased risk of high grade serous carcinoma of the pelvis (HGSC) (mostly carrying a BRCA mutation), without a history of tubal occlusion for sterilization. Women who opt to have the fallopian tubes removed but the ovaries preserved are eligible for the study too, as are women who opt for rrBSO plus hysterectomy.

NCT ID: NCT02016833 Completed - Clinical trials for Acute Myeloid Leukemia

Development of Immunological Assays for the Evaluation of Tumor Antigen Specific Immunity

Start date: October 2013
Phase: N/A
Study type: Observational

This study is a clinical study aiming at establishing immunological assays for the qualitative and quantitative evaluation of WT-1, Survivin and HPV16 E7-specific immune responses in cancer patients. Such a study will allow the development of suitable immunological tools to be used in assessing response in a subsequent phase I study aiming at evaluating therapeutic vaccine candidates targeting WT-1, Survivin and/or HPV16 E7-expressing tumors. In addition, this study will help defining the baseline cancer-associated immune responses in the selected patient population. Cervical and ovarian cancer patients, as well as leukemia patients, will be included in this study. WT-1, Survivin and HPV-specific immune responses will be monitored in these patients by ex vivo and cultured IFNg ELISpot as well as tetramer staining.

NCT ID: NCT01986725 Completed - Vulvar Cancer Clinical Trials

The Impact of the "WOMAN-PRO II Program" on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence

WOMAN-PROII
Start date: September 2013
Phase: Phase 2
Study type: Interventional

In vulvar neoplasia, even minor surgical interventions cause multiple symptoms, symptom distress and complications, which have an impact on a woman's quality of life and contribute to high health care costs. For the majority of the patients, symptom and distress can be reduced if adequate treatment is provided. This study aims to test possible differences between the impact of standardized care and the WOMAN-PRO II program on symptom prevalence in women with vulvar neoplasia after surgical treatment. In a sequential explanatory mixed-methods project, a randomized phase II study will be followed by a qualitative sub-study. Ninety patients with vulvar neoplasia treated surgically will participate in the randomized trial in four Swiss hospitals and one Austrian hospital. After stratification by precancer/cancer, women will be randomly assigned (1:2 ratio) to standardized care and the WOMAN-PRO II program. The standardized care group will receive a set of information leaflets about supportive care options in the clinic. The WOMAN-PRO II program group will obtain counseling sessions by specially trained gynecology-oncology nurse specialists at the moment of diagnosis, 7 days post-surgery, in week two after discharge, week twelve and week 24 after surgery. The primary outcome of this study is symptom prevalence. Secondary outcomes will be collected for explorative reasons and include symptom distress, uncertainty, quality of life, social support, resilience, quality of care, sociodemographic and medical characteristics, post-surgical complications, functional status, cost evaluation and process outcomes. Quantitative data will be collected at the counseling points of time and analyzed by using mixed linear regression analysis. Twenty interviews will be conducted with women of the WOMAN-PRO II program group. A focus-group interview will be conducted with twelve gynecology-oncology nurse specialists in order to better understand to which degree the interventions meet individual needs as well as to identify remaining barriers and enablers for the implementation of symptom self-management. Qualitative data will be analyzed by using thematic analysis and a critical hermeneutic reflection. This study will evaluate the impact of the WOMAN-PRO II program on symptom prevalence, patient-reported outcomes and clinical parameters, and inform the design of a possible phase III study on the clinical efficacy of the program.

NCT ID: NCT01975363 Completed - Clinical trials for Ductal Breast Carcinoma in Situ

Pilot Study of Curcumin for Women With Obesity and High Risk for Breast Cancer

Start date: June 2013
Phase: N/A
Study type: Interventional

This randomized pilot clinical trial studies a nanoemulsion formulation of curcumin in reducing inflammatory changes in breast tissue in obese women at high risk for breast cancer. Curcumin may reduce inflammation in breast tissue and fat. This may affect the risk of developing breast cancer.

NCT ID: NCT01970787 Completed - Clinical trials for HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-grade Squamous Intraepithelial Lesions.

A Trial of Radiofrequency Ablation for Anal Intraepithelial Neopplasia Using the HALO Ablation System

AIN
Start date: March 2013
Phase: N/A
Study type: Interventional

This is a Single-center prospective pilot trial involving up to 22 subjects. This study will assess the feasibility, safety, and efficacy of radiofrequency ablation (RFA) to the anal canal using the FDA cleared HALO Ablation System to eradicate anal HSIL lesions in HIV-negative subjects with intra-anal intraepithelial neoplasia (AIN). The study intervention will demonstrate that a reasonable proportion of subjects will be histologically cleared of their anal HSIL within the ETZ in a tolerable and relatively safe manner

NCT ID: NCT01969448 Completed - Breast Cancer Clinical Trials

Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction

NASSM
Start date: March 28, 2013
Phase: N/A
Study type: Interventional

The investigators hypothesize that nipple-areola skin sparing mastectomy (NASSM) performed through an inframammary incision has a superior blood supply relative to a lateral oblique incision. Moreover, by minimizing complications and optimizing aesthetic outcomes, the investigators believe it will be associated with significantly higher patient reported outcome scores. The addition of information gained by use of intraoperative laser-assisted fluorescent angiography (measured with the Spy Elite imaging device) will reduce complication rates by directing intraoperative resection of ischemic tissue and limiting the volume of immediate implant placement in instances where real time imaging would suggest compromised perfusion. These quantifiable, objective measures will justify the use of NASSM and immediate implant placement coupled with intraoperative laser-assisted fluorescent angiography in prosthetic based breast reconstruction despite longer operative times.

NCT ID: NCT01946009 Completed - HIV Clinical Trials

A Prospective, With One Site, Open-label Not Controled Trial, for the Observation of Treatment With CIDOFOVIR 1%, 3 Nights Per Week, During 4 Weeks, of Anal Intraepithelial Neoplasia, High Level, in HIV+ Patients

CIDAN12
Start date: September 2013
Phase: N/A
Study type: Interventional

Cidofovir could be an effective drug for the treatment of Anal Intraepithelial Neoplasia(AIN).

NCT ID: NCT01929993 Completed - Clinical trials for Cervical Intraepithelial Neoplasia

A Trial of Two Electrosurgical Conizations: Histopathological Analysis of Excision Margins

Start date: January 2008
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to evaluate if Straight Wire Excision of the Transformation Zone (SWETZ) is superior to (Large Loop Excision of the Transformation Zone) LLETZ cone in reducing the incomplete excision of disease.

NCT ID: NCT01924117 Completed - Clinical trials for Intraepithelial Neoplasia

Genotypification and Predisposing Factors in Human Papilloma Virus Infection

HPV
Start date: February 2011
Phase: N/A
Study type: Interventional

Objective: Determine the genotypes and risk factors associated with human papilloma virus infection in Mexican women. Methods: It was a cross-sectional study of women attended at the Materno-Perinatal Hospital "Mónica Pretelini" and the Medical Research Center (CICMED), who were asked to complete a risk factor questionnaire and submitted to colposcopy to identify SIL. Cervical swab samples were obtained to perform linear array HPV genotyping test (Roche®, Mannheim, Germany).

NCT ID: NCT01923116 Completed - HIV Clinical Trials

Therapeutic HPV-16 Vaccination for the Treatment of Anal Dysplasia

VACCAIN-T
Start date: August 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of the study is to assess, in a phase 1/2 study, the safety and efficacy of this synthetic vaccine SLP-HPV-01® in HIV+ men with CD4 counts > 350 x 10E6/l and HPV16-induced intra-anal high-grade AIN (grade 2-3) that failed on, or recurred after previous treatment.