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Ovarian Cysts clinical trials

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NCT ID: NCT06350227 Recruiting - Ovarian Cyst Benign Clinical Trials

Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst

Start date: April 10, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the impact of different hemostasis methods during laparoscopic ovarian cystectomy on ovarian function and fertility in women with benign ovarian cysts.

NCT ID: NCT06342934 Completed - Ovarian Cancer Clinical Trials

Radiomics and Machine Learning in the Diagnosis of Ovarian Masses

Multi-AROMA
Start date: July 22, 2020
Phase:
Study type: Observational

The correct differential diagnosis between benign and malignant adnexal masses is the main goal of preoperative ultrasound diagnostics and is very important to plan the correct treatment for the patient in terms of surgical team (gynecologist oncologist or benign pathology center), surgical access (laparoscopy / laparotomy) and type of surgery (conservative / demolitive). Several ultrasound models have been developed to help gynecologists define the risk of malignancy of adnexal masses. In order to use the predictive models, the examiner had to collect certain ultrasound features of the lesion which, integrated with the patient's clinical and / or biochemical characteristics, provided a risk of malignancy of the mass. Recently radiomics is emerging as an interesting tool to be applied to diagnostic imaging (computed tomography, magnetic resonance and even ultrasound). Radiomics is the evaluation of images through complex software that allows to 'read' the intrinsic characteristics of the tissue identifying aspects that are not visible by subjective interpretation of the operator, in a fully automated and therefore reproducible way. Radiomics applied to artificial intelligence for the creation of predictive models represents an interesting tool to overcome the limitations of previous models, at least partly dependent on the operator's experience. Among the serous ovarian cancer, those with BRCA gene mutation represent an interesting subgroup and are characterized by a different pathophysiological history than wild type tumors due to greater chemosensitivity and the possibility of targeted treatment with antiangiogenic drugs and PARP-inhibitors. The application of radiomics to preoperative ultrasound images could identify BRCA mutated tumors before surgical planning (radiogenomic analysis) and allow a personalized treatment. The aim of the study is to validate a predictive model to define the risk of malignancy of adnexal masses that the investigators developed at the Fondazione IRCCS Istituto Nazionale dei Tumori di Milano. The model, based on the integration of radiomics and artificial intelligence, uses complex software capable of 'reading' the ultrasound images in a completely automatic way and is able to estimate the risk of malignancy of the mass. If the patient decide to participate in the clinical study, the patient will undergo transvaginal ultrasound (eventually supplemented by transabdominal ultrasound in case of large adnexal masses, if the patients are virgo or if the patients will refuse transvaginal approach for any reason). This exam is part of the routine preoperative evaluation for adnexal pathology and therefore the patients don't have to undergo any additional clinical, biochemical or imaging examination, according to national and international guidelines. Thereafter, the images stored during the preoperative ultrasound will be exported in anonymous format from the ultrasound system, and sent to the coordinating center (Fondazione IRCCS Istituto Nazionale dei Tumori di Milano). There, images will be submet to radiomic analysis through the application of a dedicated software; that will allow to evaluate the intrinsic characteristics of the tissue according to different parameters (shape, intensity, grade of heterogeneity and many others) of the 'pixels' (gray dots) that constitute the ultrasound image. This analysis, once validated, will provide clinicians an additional tool to identify malignant adnexal masses prior to surgery. If the final histological diagnosis is of serous epithelial ovarian cancer, through the use of the same radiomics software described above the investigators will try to identify the intrinsic characteristics of the tissue associated with the presence or absence of the BRCA 1 or 2 mutation

NCT ID: NCT06227676 Completed - Clinical trials for Polycystic Ovary Syndrome

Effect of 'Cramp Bites' on Period Cramps in Women Aged 18-25

NUTRITION; GYN
Start date: July 21, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

85 percent of women of reproductive age experience consistent period cramps/menstrual pain, and 60% indicate that they do not use painkillers to relieve menstrual symptoms; there is a need for natural and non-medicative supplements to dysmenorrhea. The purpose of this clinical trial is to examine the effect of 'Cramp Bites'--classified by a mixture of natural ingredients researched to help with period pain--on women suffering from primary dysmenorrhea: this will be done through providing participants with the snack and surveying them on how it changes their period symptoms.

NCT ID: NCT06064331 Completed - Appendicitis Clinical Trials

Effect of Intravenous Lignocaine Infusion on Intraoperative End Tidal Desflurane Concentration Requirements

Start date: January 21, 2021
Phase: N/A
Study type: Interventional

Lignocaine is a local anaesthetic that is widely used in all medical and surgical fields. Many clinical studies have shown that intravenous (IV) lignocaine given in the perioperative period was safe, reduced airway complications, obtunds cough reflex, reduce sore throat, pain, opioid consumption, nausea, length of hospital stay. Multiple animal studies have shown that IV lignocaine was able to lower anaesthetic gas requirements. Desflurane is an anaesthetic gas that has a rapid onset and offset of action. This study aims to evaluate the effect of IV lignocaine infusion on desflurane requirements. Hypothesis of the study is that IV lignocaine infusion reduces desflurane requirements.

NCT ID: NCT05842629 Recruiting - Ovarian Cancer Clinical Trials

Improved Diagnosis of Ovarian Cancer

Start date: May 15, 2021
Phase:
Study type: Observational

After implementation of systematic image description of adnexal masses, we aim to improve and evaluate our use of available imaging methods and biomarkers for classifying adnexal masses and distinguishing between benign and malignant adnexal masses in the hands of clinicians in Central Denmark Region. Secondarily, we want to improve our management of adnexal masses by evaluating the complications and longitudinal changes in conservatively managed adnexal masses. Data is registered prospectively but analyzed retrospectively.

NCT ID: NCT05800613 Completed - Pediatric ALL Clinical Trials

Management of Ovarian Masses in Pediatric Patients: an Italian Survey

OvaMa-PEDs
Start date: June 16, 2022
Phase:
Study type: Observational

Objectives: The International Ovarian Tumor Analysis (IOTA) provides a specific terminology for adult ovarian masses, while, currently, there is no systematic classification for preoperative assessment of adnexal lesions in childhood and adolescence. This study aims to survey Italian pediatric surgeons to evaluate ovarian masses' management (from diagnosis to treatment) in patients aged 1-18. Methods: A 27-question survey was distributed. It consisted of questions regarding the management and use of ultrasound and IOTA terminology in diagnosing ovarian masses in childhood and adolescence, in emergency regimes and in planned surgeries.

NCT ID: NCT05763511 Recruiting - Ovarian Neoplasms Clinical Trials

Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker

Start date: July 1, 2022
Phase:
Study type: Observational

This project investigates circulating tumor DNA (ctDNA) in patients with suspected ovarian malignancy. We hypothesize that measurement of ctDNA in women with suspected ovarian cancer can improve the diagnostic efficiency for preoperative differentiation between benign and malignant masses. Specifically, we hope to determine the diagnostic efficiency of ctDNA alone and ctDNA in combination with imaging modalities (ultrasonography, MRI, PET-CT) and CA 125 for preoperative differentiation between benign and malignant adnexal masses. Based on this, we hope to develop an improved diagnostic algorithm. The mutational profile and relation to tumour type, stage, treatment response and prognosis will be explored. Analyses of blood and tissue samples will be used to examine the disease development and biology. Blood samples, tumour tissue and data on imaging modalities as well as CA 125 will be collected prospectively in consecutive women referred to Aarhus University Hospital.

NCT ID: NCT05514028 Recruiting - Ovarian Cancer Clinical Trials

Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin

OVAmiARN
Start date: May 4, 2022
Phase:
Study type: Observational

OVAmiARN is a multicentre, prospective, longitudinal, non-interventional, observational study carried out in 8 obstetrics and gynecology departments in France; in order to describe the evolution of salivary miRNA expression between the pre-operative and post-therapy visits according to the type of mass. In time, the clinical application will be to significantly reduce the time to diagnosis and improve the care pathway for ovarian adnexal mass. The study population consists of patients with an ovarian adnexal mass diagnosed by clinical examination and imaging (pelvic ultrasound and/or MRI) and requiring surgical management in routine care. The patients concerned by the study will be managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic or follow-up examinations (imaging or biology) necessary according to the context, which are carried out according to the recommendations of the HAS, CNGOF. In this study, the management and follow-up of patients : - Are not imposed by the study: the doctor remains free to make medical prescriptions (treatments and examinations) and to determine the interval between consultation visits, - Are not modified in comparison with the usual follow-up, except for the performance of the Collection of saliva

NCT ID: NCT05418595 Completed - Ovarian Cysts Clinical Trials

Ultrasonographic Evaluation of Ovarian Stromal Vascularity in Women With Polycystic Ovary Syndrome (PCOS)

Start date: June 13, 2022
Phase:
Study type: Observational

The most common endocrine condition in reproductive women is polycystic ovary syndrome. It has a prevalence of 5-10%. According to the Rotterdam criteria, oligo/anovulation, clinic or biochemical hyperandrogenism, PCOS morphology in ultrasonography, and the presence of these two criteria are required for diagnosis. The echogenicity of the ovarian stroma, vascularity, ovarian size, cystic pattern density, and subcortical organization of cysts are all significant considerations in ultrasonographic evaluation.

NCT ID: NCT05376384 Completed - Ovarian Cysts Clinical Trials

Ovarian Cyst's Enucleation Spillage Score

OC-ESS
Start date: May 12, 2022
Phase:
Study type: Observational [Patient Registry]

Cystic enucleation is one of the most common conservative surgeries in gynecology; it is commonly performed by a minimally invasive approach such as laparoscopy. A high percentage of these surgeries (6-88 % of cases) are complicated by the cystic rupture with intra-abdominal spillage of its contents (spillage). This occurrence affects the surgical and prognostic outcome by lengthening the time of surgery, increasing the risk of postoperative infection or granulomatous peritonitis, of possible second manifestation of the pathology (example: endometriosis), and in the case of neoformation of a carcinomatous nature by leading to an increase in the stage of disease, exposing patients to a prognostic disadvantage and the need for adjuvant treatments also avoidable. In addition, the previous spillage may be associated with the adherent syndrome with repercussions on patients' morbidity and fertility. For these reasons, it is crucial to optimize the selection of patients who are candidates for cystic enucleation. The present study aims to evaluate a series of ultrasound, medical history, and surgical-preoperative parameters to develop a predictive score for the risk of spillage during laparoscopic surgery. Prospective Observational Study. The study aims to enroll 156 patients.