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Diagnostic Accuracy clinical trials

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NCT ID: NCT04651738 Recruiting - Endometrial Cancer Clinical Trials

Cell-free DNA Methylation for Endometrial Cancer

Start date: December 18, 2020
Phase: N/A
Study type: Interventional

Liquid biopsy is challenging for the diagnosis of endometrial cancer. In this study, investigators perform the methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in endometrial cancer. The study compromises two stages. In the training set, DNA methylation testing is performed in the endometrial tissues from patients with endometrial cancer and paired benign uterine lesions. The cut-off values of methylation are produced in this stage. On the meantime, DNA methylation testing is also performed in serum and in cervical cytology to reveal its accordance and accuracy compared with the results of endometrial tissues. In the validation set, serum DNA methylation testing is performed in unselected patients with definite endometrial histology to validate its accuracy. In training and validation sets, serum DNA methylation is also performed after major surgeries for endometrial cancer as to illustrate the changes of methylation testing, therefore, reflection the supervision role of DNA methylation.

NCT ID: NCT04650711 Recruiting - Clinical trials for Cervical Intraepithelial Neoplasia

Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

Start date: November 26, 2020
Phase: Phase 2
Study type: Interventional

Cyclin kinase inhibitor P16INK4A has overexpression in cervical cancer, and hence becoming an alternative method for cervical cancer screening. This study is to investigate the clinical value of P16INK4A and high-risk human papillomavirus (hrHPV) detection of cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). All eligible participants accept P16INK4A testing, with cytology and/or hrHPV assay. P16INK4A immunohistochemical staining is performed on the retained specimens of cytology. The primary endpoint is the diagnostic accuracy of P16INK4A compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.

NCT ID: NCT02834585 Recruiting - Sarcoma Clinical Trials

Magnetic Resonance Imaging or Ultrasound in Soft Tissue Tumors (MUSTT)

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

Adult soft tissue sarcomas (STS) are rare tumours with an estimated incidence averaging 5/100 000/year in Europe. The prognosis of soft tissue sarcomas is dominated by local recurrence and distant metastasis. A link seems to exist between local recurrence and overall survival. Local recurrence occurs in approximately 16-29% of STS of the limbs. A combination of resection and radiotherapy is the optimal treatment of primary tumours according to histological grade and surgical result. Modern imaging techniques such as ultrasound (US), magnetic resonance (MR) and computed tomography (CT) are normally used to rule-out a recurrence in patients operated on for STS. However, none of this technique is perfect and different advantages and drawbacks have to be considered in choosing one or another technique. In the past, US was used in tumour follow-up to detect tumour recurrences, however these studies didn't use high-resolution transducers and the timing of imaging respect to surgery was not defined. The recent advances in transducer technology improved the diagnostic capabilities of US. For the evaluation of limbs soft-tissue masses, US is widely used as a first level modality. The reasons are that US is widely available, fast, easily repeatable and often more accessible than CT and MR Imaging. In addition, US equipped with high-frequency transducers have a spatial resolution that may be comparable or higher than that of MR Imaging and CT in the evaluation of superficial soft-tissues. US and MR Imaging are often not able to differentiate benign from malignant tumours, therefore several lesions detected with US or MR Imaging warrant biopsy. The clinical practice guidelines of the ESMO (European Society of Medical Oncology) published in 2010 found that there are no published data to indicate the optimal routine follow-up policy of surgically treated patients with localized disease. Moreover, it has not been demonstrated that, for limb sarcomas recurrences, MR Imaging is superior and cost-effective compared to US for the assessment of the primary site. Considering that surgically treated intermediate-/high-grade patient may be followed frequently, even every 3-4 months in the first 2-3 years and considering that performing US is easier than having MR Imaging, the purpose of this study is to evaluate the diagnostic performance of US in the detection of local recurrences of adults patients with soft tissue sarcomas of the limb.