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Diagnoses Disease clinical trials

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NCT ID: NCT05120167 Completed - Cervical Cancer Clinical Trials

Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy

Start date: September 29, 2021
Phase: N/A
Study type: Interventional

cervical cancer is the fourth most frequent cancer in women worldwide and in Brazil, it occupies the third position for the triennium 2020/2022, with a high mortality rate and maintained in the last 10 years. It is associated with persistent human papillomavirus (HPV) infection. Primary prevention can be accomplished through vaccines that prevent HPV infection of the epithelial cells of the cervix. Secondary prevention in screening for precursor lesions through periodic repeat cervical sampling in a population of asymptomatic women. Women with abnormal cytology are more likely to have pre-invasive or invasive lesions and are referred for further testing, colposcopy. Colposcopy identifies suspicious areas and guides the best site for biopsy. In the situation of negative colposcopy and abnormal cytology, suspicion for high-grade lesion (HSIL). It recommends further investigation of the endocervical canal before the possible excisional procedure and obtaining an additional canal sample by brushing or curettage. However, to date, there is no consensus and studies lack consistent results on which is the best method for further investigation of the endocervix. Objectives: To compare the performance of additional strategies in the investigation and detection of precursor or invasive lesions in the endocervical canal in women with abnormal cytology (ASC H+) and with initial colposcopy without suspicious images.

NCT ID: NCT05088811 Recruiting - Clinical trials for Hepatocellular Carcinoma

The Role of Long Non-coding RNAs WRAP53 and UCA-1 as Potential Biomarkers in Diagnosis of Hepatocellular Carcinoma

Start date: August 21, 2021
Phase:
Study type: Observational

The aim of this work is to study the role of long non-coding RNAs WRAP53 and urothelial carcinoma-associated 1 (UCA1) as potential biomarkers in diagnosis of hepatocellular carcinoma.

NCT ID: NCT05085301 Completed - Malaria Clinical Trials

RapiGEN BIOCREDIT Malaria Ag RDTs WHO Prequalification Study

Start date: December 1, 2021
Phase:
Study type: Observational

Since their introduction in the late 90's, rapid diagnostic tests (RDTs) have markedly improved our ability to control malaria; yet they have inherent limitations which include low sensitivity in Plasmodium vivax detection and inability to detect hrp2/3 gene deleted Plasmodium falciparum parasites. In addition, the spread of P. falciparum parasites lacking hrp2 gene jeopardizes the long-term use of P. falciparum-specific HRP2-based RDTs. A partnership between RapiGEN, FIND, and the Bill and Melinda Gates Foundation (BMGF) is addressing these limitations by developing five novel malaria RDTs with improved pLDH and HRP2 detection. RapiGEN has also developed three novel malaria RDTs - BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH), BIOCREDIT Malaria Ag Pf (pLDH/HRP2) and BIOCREDIT Malaria Ag Pf (pLDH) - to address these drawbacks. The BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) is a combo test that detects P. falciparum and P. vivax on a single device. BIOCREDIT Malaria Ag Pf (pLDH/HRP2) targets both PfLDH and HRP2 antigens in P. falciparum; and BIOCREDIT Malaria Ag Pf (pLDH) has improved detection of pLDH in P. falciparum. In countries with circulation of hrp2/3 deleted P. falciparum malaria parasites or high P. vivax burden, these improved RDTs may be invaluable in malaria elimination. This study is a prospective and retrospective evaluation of RapiGEN's BIOCREDIT Malaria Ag RDTs in malaria-endemic countries to assess their clinical performance for detection of malaria. The purpose of this study is to provide a high level outline of the study design and conduct to support the collation of a data package for WHO Pre-Qualification proposed study.

NCT ID: NCT05064566 Not yet recruiting - Diagnoses Disease Clinical Trials

Evaluation of Caries Detection Methods

Start date: October 20, 2021
Phase:
Study type: Observational

The investigators aim will be to compare the diagnostic performance of clinical visual examination (ICDAS II), intraoral/bite wing radiography (BW), near infrared light transillumination (NIR-LT), and laser fluorescence (LF), in comparison to microcomputed tomography (micro-CT) for the detection of non-cavitated occlusal enamel and dentin caries in third molar teeth. Potential participants will be consecutively recruited.

NCT ID: NCT05047315 Recruiting - Tuberculosis Clinical Trials

Evaluating a New Stool Based qPCR for Diagnosis of Tuberculosis in Children and People Living With HIV

Stool4TB
Start date: December 1, 2021
Phase:
Study type: Observational

Stool4TB aims to evaluate an innovative stool-based qPCR diagnostic platform (with the capacity to become a POC diagnostic tool) in the high TB and HIV burden settings of Mozambique, Eswatini and Uganda, under the hypothesis that it will narrow the extremely large TB case detection gap by improving TB confirmation rates in children and people living with HIV (PLHIV).

NCT ID: NCT05043662 Recruiting - Clinical trials for Urothelial Carcinoma

UroCAD Assay Combined With Computed Tomography Urography and Urine Cytology for UTUC Diagnosis.

Start date: September 1, 2021
Phase:
Study type: Observational

Upper tract urothelial carcinoma (UTUC) diagnosis include urography using computed tomography urography (CTU) or urography using MRI (MRU). The sensitivity of CTU decreases substan¬tially with decreasing lesion size. Other drawbacks of CTU include the radiation exposure and potential adverse effects in patients with allergic reactions or pre-existing renal impairment. In terms of urine cytology, the major drawbacks of urine cytology are low sensitivity and highly dependent of the experience and skills of the cytopathologist. We here intended to investigate whether UroCAD can be added in the diagnostic work-up of UTUC patient, and improve the accuracy of predicting UTUC before surgery.

NCT ID: NCT05042557 Recruiting - Diagnoses Disease Clinical Trials

Real World Study of MPM in China

Start date: June 1, 2021
Phase:
Study type: Observational

Malignant pleural mesothelioma (MPM) is a highly aggressive tumor with atypical clinical manifestations. Most patients with MPM are at an advanced stage at the time of diagnosis, and only a few patients can be cured by radical surgery and other treatment measures. Pemetrexed + cisplatin chemotherapy with or without bevacizumab is still the standard treatment for MPM. In recent years, multimodality therapy including surgery, radiotherapy and chemotherapy have shown certain advantages in improving patient overall survival time. Targeted and immunotherapy may bring breakthroughs in MPM therapy. However, there are still no high-quality evidence-based medical evidence reports on the treatment model and effects of MPM patients in China. Focusing on MPM, we plan to systematically review the relevant scientific literature, confirm relevant scientific research questions, and provide references for related treatments. On this basis, we will estimate MPM incidence and mortality rates from 2014 to 2025 based on the data published by the National Cancer Registry. Meanwhile, a retrospective study cohort was constructed based on the electronic medical record database, and according to the research demand, patients were followed up with their post-discharge survival status to comprehensively describe and analyze the incidence, diagnosis, treatment, and prognosis of MPM patients. Also, exploratory analysis of the therapeutic effects of existing clinical treatments was conducted.

NCT ID: NCT04985188 Not yet recruiting - Diagnoses Disease Clinical Trials

Quantitative Ultrasound for Diagnosing Hepatic Steatosis in Nonalcoholic Fatty Liver Multicenter Study

Start date: August 12, 2021
Phase:
Study type: Observational

To evaluate the diagnostic performance of quantitative ultrasound parameters for assessing hepatic steatosis in non-alcoholic fatty liver disease using histologic results as reference standard

NCT ID: NCT04955197 Recruiting - Oral Cancer Clinical Trials

Exfoliated Cytology in Detection of Oral Premalignant and Malignant Lesions

Start date: December 1, 2020
Phase:
Study type: Observational

Micronuclei have been used since 1937 as an indicator of genetic toxic exposure due to their association with chromosomal alterations. They can be detected in exfoliated cells and used as an indicator of recent DNA injury within oral mucosa. The buccal epithelial cells are first to be interacted with the cancer compounds such as tobacco (nicotine), which in turn induces the frequency of micronuclei under the influence of saliva. The exfoliated cell micronuclei assay involves microscopic analysis of oral smears to determine the prevalence of micro-nucleation. The assay is reliable and technically easy to perform, noninvasive and sensitive with limited cost.

NCT ID: NCT04891029 Recruiting - Diagnoses Disease Clinical Trials

Early Detection of Endometrial/Ovarian Cancer and Hereditary Predisposition of These Cancers

Start date: May 10, 2021
Phase: N/A
Study type: Interventional

Early stage high-grade cancer, endometrial and ovarian, has few, if any, symptoms or signs. When symptoms appear, the disease may be in advanced stage as the disease has left the gynaecological organs and metastasized to the pelvic/abdominal cavity. The McGill research group had showed in the DOvEE trial (NCT02296307), that fast-track assessment with transvaginal ultrasound scans (TVUS) and serial CA125 of women with vague symptoms associated with ovarian and endometrial cancer did diagnose these cancers earlier in the disease trajectory, with low-volume resectable disease, but only after the cancer had already become Stage III. One way to detect these cancers earlier is to screen asymptomatic women. Unfortunately, none of the currently available tests, including TVUS and CA-125 have been shown to be useful for screening for ovarian or endometrial cancer. The McGill team has developed a genomic assay to screen and detect these cancers earlier in the trajectory than is currently the case. The test identifies pathogenic somatic mutations (necessary early steps in the development of these cancers), in an uterine cytological sample. It is able to do so by incorporating a deep machine-learning derived classifier that can discriminate the mutational signature of these cancers from benign disease with a sensitivity of 70% and a specificity of 100% in a population with high background mutational burden. In addition to the intra-uterine cytological sample, the test includes an assay of a saliva sample to identify germline mutations that predispose to hereditary endometrial/ovarian cancers as well as breast and colon cancers. The test was developed in a retrospective population in whom the assay was done pre-operatively and the diagnosis of malignancy versus benign gynecological disease was confirmed by detailed pathological analysis of the uterus, tubes, and ovaries after surgical resection (NCT02288676). The test is now ready to be tested as a phase III diagnostic test in the general population to see if these results are just as promising in the community at large.