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Uterine Cervical Neoplasms clinical trials

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NCT ID: NCT02116920 Recruiting - Cervix Cancer Clinical Trials

HPV E6/E7 mRNA Versus HPV DNA as Triage for Cervical Cancer Screening

PODBT
Start date: May 2013
Phase: N/A
Study type: Observational

AIM: To develop and standardize a cost effective methodology or algorithm for mRNA E6/E7 for HPV genotypes 16, 18, 31, 33 and 45 as compared to commercially available assays which can be incorporated to triage excess false positives from primary screening for cervical cancers Objectives: 1. Development and standardization of methodology /algorithm for mRNA E6/E7 testing for HPV genotypes 16, 18, 31, 33 and 45 using Real-time RT-PCR, in cervical samples. 2. To compare the test performance of this HPV E6/E7 mRNA assay to HPV DNA by HC 2 as secondary screening test, with the reference standard of colposcopy with biopsy, to triage women found positive in primary screening by VIA , in a population based screening for cancer of cervix. 3. To determine number of false positives in the primary screening test after testing VIA positives with a known high specificity secondary screening test (HPV-DNA HC II ) compared to HPV E6/E7 mRNA testing. Study Population: Women in the age group of 30-65 years, who test positive on primary cervical screening test VIA will be enrolled for the proposed diagnostic tests along with reference standard of colposcopy with guided biopsy. Methodology: Women in the age group of 30-65 years undergoing routine cervical cancer screening through hospital ( Preventive Oncology screening clinic) and community based screening programs with abnormal test result using the primary cervical cancer screening test VIA will be recruited in the study. The primary screening test VIA will be administered by application of 5% Acetic Acid to the cervix and visualizing the cervix with the help of a halogen focus lamp. VIA will be considered to be positive if definite acetowhite lesions are visualized close to the squamocolumnar junction.

NCT ID: NCT02096016 Recruiting - Recurrence Clinical Trials

HPV-test, Cervical Cancer and Follow-up

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

The investigators have planned this project to evaluate the follow-up program after surgery due to cervical cancer and to explore the possibilities for different tests of Human Papilloma Virus (HPV) in contributing to the customization of the follow-up program. Purpose: The investigators effort is to provide the background for an evidence-based update of the follow-up program after surgery due to cervical cancer with the purpose of early diagnosis of recurrence affecting quality of life for as few women as possible.

NCT ID: NCT02095119 Completed - Clinical trials for Uterine Cervical Cancer

A Monoclonal Antibody, Nimotuzumab, as Treatment for Recurrent or Metastatic Cervical Cancer

Start date: July 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The following is an open label, non comparative, pilot study of palliative treatment as a second, third line or more of treatment in patients with recurrent, persistent or Metastatic Cervical Cancer; it has a limited sample of 15 patients with the primary goal of evaluating the response (defined as: Complete, partial or stable disease) to treatment with a Monoclonal Antibody, Nimotuzumab, on a weekly basis + CDDP 50mg/m2/BSA as a single agent every 3 weeks for patients with good renal function (Creatinine clearance => 60) or Gemcitabine 800 mg/m2/BSA in patients with renal failure (Creatinine clearance <60). Secondary objectives consist of evaluating disease-free survival, overall survival and assess patient tolerance to treatment with Nimotuzumab.

NCT ID: NCT02091050 Completed - Endometrial Cancer Clinical Trials

2D vs 3D Planning for High-Dose Rate (HDR) Gynecological Brachytherapy

Start date: June 2014
Phase: Phase 2
Study type: Interventional

Demonstrate the limitations of conventional dosimetry (2D) for the adjuvant brachytherapy treatment and assess whether tridimensional dosimetry relates more faithfully with the occurrence of adverse effects.

NCT ID: NCT02083848 Completed - Cervical Cancer Clinical Trials

Detection of Loco-regional Invasion of Cervical Cancer With 7 Tesla MRI

DETECT
Start date: March 2014
Phase: N/A
Study type: Interventional

Background of the study: The accurate assessment of local cervical cancer spread (i.e. invasion) is of clinical importance for staging and treatment considerations. For example, if parametrial invasion is absent, radical surgery is the treatment of choice for tumors less than 4cm in diameter. However, if such invasion is present, the patient has become inoperable and (chemo)radiotherapy is warranted. Unfortunately, regular 1.5T MRI as a part of staging work-up has a limited accuracy for detecting loco-regional tumor invasion. Due to relatively frequent false-negative findings a risk of understaging and under-treatment occurs. For such cases adjuvant treatments with (chemo)radiotherapy are indicated after the initial surgery, causing increased morbidity and treatment associated risks. For higher stages, with primary (chemo)radiotherapy, a more reliable MRI based delineation of local tumor spread could enable individualized dose(volume) and field modifications. Hypothesis/aim of the study: To develop and in vivo optimize T2w ultra high field (7T) MRI sequences, which use a combination of an endorectal and external coil, to image the (para)cervical area for assessment of the loco-regional tumor status in cervical cancer. Study design: The proposed study is an investigator initiated, single center, prospective pilotstudy. Study population: 20 patients with histological proven cervical cancer stage IB1, IB2, IIA of IIB will be included. Primary study parameters/outcome of the study: Optimized T2w ultra high field (7T) MRI sequences of the (para)cervical area which allow qualitative assessment of the loco-regional invasion of cervical cancer.

NCT ID: NCT02083211 Completed - Clinical trials for Palliative Treatment

Combination of Nimotuzumab Cisplatin-Vinorelbine in First Line Chemotherapy in Recurring-Persistent Cervical Carcinoma

Start date: July 2010
Phase: Phase 3
Study type: Interventional

This study evauates the global survival of patients following administration of mAb Nimotuzumab hR3 + chemotherapy in the treatment of cervical cancer in first line therapy, after relapsing from chemo-radiotherapy. It is a Phase III, multi-centric, randomized, double blind study; 168 patients will be assigned to Nimotuzumab + Cisplatin/Vinorelbine or placebo + Cisplatin/Vinorelbine. After progression, a second line chemotherapy based on carboplatino/taxol will be administered in both groups. Concomitant administration of Nimotuzumab will be continued every 14 days until limiting toxicity or ECOCG >3. Tumor markers such as Kras, p53, KI67, and EGFR will be identified. Cardiac toxicity will be evaluated using MRI.

NCT ID: NCT02069769 Completed - Ovarian Cancer Clinical Trials

Ensuring Communication in Hospice by Oncology Study (ECHO)

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

The goal of this study is to determine if scheduled communication with the oncology team through phone calls is helpful to caregivers with the transition to hospice care.

NCT ID: NCT02067468 Completed - Cervical Cancer Clinical Trials

Optimal Strategy for the Management of ASCUS Cytology in Health Care Services of Medellin, Colombia

ASCUS-COL
Start date: January 2011
Phase: N/A
Study type: Interventional

Cervical cancer as well cervical preneoplastic abnormalities (CIN2+) are cause by human papillomavirus (HPV) infection. These abnormalities have been historically detected by cervical cytology, but recent evidence shows that HPV testing is superior to cytology to detect cervical lesions that eventually will progress to cancer. Despite evidence, conventional cytology (Pap) remains as a primary screening test in Colombia and HPV test is recommended as a triage test for women with atypical squamous cells of undetermined significance (ASC-US) in settings around the world. Women with ASC-US have low risk to CIN2+ but higher than healthy population, and therefore it is important to provide appropriate clinical management. However, there is no consensus of how to deal women with ASC-US and therefore there are still three strategies for this purpose: 1) immediate colposcopy, 2) repeat conventional cytology at 6 and 12 months and 3) HPV testing. The main objective of this study is to compare the effectiveness and the efficient among the strategies as well as to evaluate the acceptability of the HPV testing in a real-life setting.

NCT ID: NCT02046265 Active, not recruiting - Cervical Cancer Clinical Trials

Clinic-based Intervention to Promote Cervical Cancer Prevention Behaviors

StepUp
Start date: June 2014
Phase: N/A
Study type: Interventional

The project is a clinical behavioral research project based at University of Pennsylvania. The goal of this research is to design a brief clinic-based, Nurse Practitioner-guided, and theory-based health promotion intervention to enhance cervical cancer prevention among young women ages 18-26 living in economically disadvantaged urban communities. The investigators will evaluate the intervention for feasibility, acceptability and preliminary efficacy.

NCT ID: NCT02045433 Terminated - Clinical trials for Locally Advanced Cervical Cancer

Stereotactic Body Radiation Therapy (SABR) for Definitive Treatment of Locally Advanced Cervical Cancer

Start date: March 27, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether SABR boost therapy is effective in women with locally advanced cervical cancer without increased risk of acute gastrointestinal (GI) or genitourinary (GU) toxicity.