Ovarian Cyst
An ovarian cyst is a fluid-filled sac or pocket within or on the surface of an ovary.
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Found 40 Actively Recruiting clinical trials
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The goal of this clinical trial is to compare pregnancy rates after different surgical treatments for endometriomas in adult women who have one or more ovarian cysts (endometriomas) larger than 2 cm requiring surgery. The main questions it aims to answer are: How many women become pregnant within 24 months after surgery ? What are the birth rates and different types of pregnancies (natural, with fertility treatments, and those continuing beyond 12 weeks)? How often do the endometriomas come back after surgery? What surgery-related complications occur? How do pain levels change after treatment? Researchers will compare different surgical treatment groups to see if one approach results in better pregnancy outcomes and fewer complications. Participants will: Be randomly assigned to different surgical treatment groups Undergo surgery for their endometriomas and endometriosis Attend follow-up visits at 3 months and 24 months after the procedure Have their pregnancy outcomes, pain levels, and potential complications monitored throughout the study period
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This is a single-arm, exploratory study. People with recurrent platinum-resistant ovarian cancer who have not received any previous systemic antitumor therapy for ovarian cancer were selected to evaluate the efficacy and safety of adebrelimab combined with fuzuloparib.
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Healthy Volunteer
PDAC is projected to become the second-leading cause of cancer mortality by 2030, with stage-specific survival disparities reaching 83.7% for stage IA versus 2.9% for stage IV disease. This dramatic survival gradient highlights the transformative potential of stage migration through early detection. Screening-based early detection has demonstrated improved prognosis for PDAC patients; however, implementation faces dual challenges. he low incidence of PDAC renders population-wide screening cost-ineffective, while current screening methods are hampered by high false-positive rates and overdiagnosis risks. In this context, opportunistic screening has garnered attention for its unique implementation advantages. By leveraging existing imaging resources from routine clinical encounters or health check-ups, this approach obviates the need for additional screening infrastructure, potentially reducing healthcare resource consumption while effectively increasing screening coverage among high-risk populations. Non-contrast computed tomography (NCCT), despite its widespread clinical application and operational convenience, is limited by suboptimal soft tissue resolution, resulting in insufficient sensitivity for early pancreatic lesions (≤2 cm), thus significantly constraining its utility in opportunistic screening. Recent advancements in AI technology have significantly impacted the field of medical image analysis. These techniques have enabled the automation of the detection of subtle pancreatic lesion features in large-scale imaging data, with the potential to enhance the accuracy and efficiency of early pancreatic cancer detection. In preliminary research, a deep learning-based model for pancreatic cancer detection was developed by our team. This model demonstrated the ability to accurately detect and classify pancreatic lesions on NCCT images, with excellent performance in multicenter validation studies. The model also exhibited strong generalizability when applied to chest CT scans. Therefore, AI-powered NCCT shows significant potential for application in hospital-based opportunistic screening programs and may become an effective tool for early pancreatic cancer detection. However, further research is required to fully explore and realize this potential. This prospective, observational, multi-center study will evaluate the performance of an AI-powered opportunistic screening system utilizing NCCT acquired during routine clinical encounters or health check-ups. The deep learning-based detection system will perform automated identification of pancreatic lesions, including PDAC and precursor entities (intraductal papillary mucinous neoplasms \[IPMN\], mucinous cystic neoplasms \[MCN\]). Algorithm-positive cases will be independently reviewed by two radiologists. Individuals with high suspicion after radiologists review will undergo further validation via serological tests (e.g., CA19-9, CEA) and imaging studies (e.g., contrast-enhanced CT, contrast-enhanced MRI, EUS-FNA). Participants with a confirmed positive diagnosis will undergo multidisciplinary consultation and specialized treatment, while those with a negative diagnosis will be followed clinically for at least one year. The AI system's performance will be evaluated through three primary metrics: (1) Detection rate of PDAC and high-risk precursor lesions, defined as the proportion of histologically confirmed PDAC and precursor lesions (IPMN/MCN) meeting Sendai criteria among all participants undergoing CT screening. (2) Recall rate, defined as the proportion of individuals recalled for confirmatory testing after AI-positive screening and radiologist review among all participants undergoing CT screening. (3) Positive predictive value (PPV) defined as the proportion of histologically confirmed PDAC and high-risk precursor lesions among all AI-positive screening cases. Institutional Collaboration: Led by Shanghai Changhai Hospital (PI: Gang Jin, MD) with five regional centers (Yinzhou Hospital, Jiaxing University Hospital, Lishui Central Hospital, Jingning County Hospital) and Alibaba DAMO Academy (technical support).
RECRUITING
Healthy Volunteer
Pancreatic ductal adenocarcinoma (PDAC) is an extremely aggressive cancer with a dismal 5-year survival rate of just 13%. The key to improving outcomes lies in early detection, as patients diagnosed at an early stage (IA) can achieve an 80% 5-year survival. However, current screening methods are limited, focusing only on high-risk populations and lacking effectiveness for the general public due to the cancer's relatively low incidence and high false-positive risks. Contrast-enhanced CT (CE-CT), the primary imaging modality, faces barriers for widespread implementation due to its invasiveness, high costs, and need for contrast agents. In this context, low-dose CT (LDCT) emerges as a promising alternative, having demonstrated success in lung cancer screening by reducing radiation exposure. Retrospective analysis revealed that one-third of pancreatic abnormalities were missed during routine LDCT interpretations, suggesting the untapped potential of LDCT-based pancreatic lesion screening. Breakthroughs in AI have transformed medical imaging. Our PANDA (pancreatic cancer detection with artifcial intelligence) system excels at pancreatic cancer detection, utilizing innovative registration techniques and a cascaded deep learning framework (UNet+Max-Deeplab) for comprehensive lesion analysis. Validated across 10 centers (6,239 patients), PANDA outperformed radiologists. Real-world testing (20,530 cases) demonstrated remarkable accuracy: 92.9% sensitivity and 99.9% specificity, maintaining 92.2% sensitivity even for small T1 tumors. On LDCT, PANDA achieved 0.979 AUC without protocol modifications, confirming "LDCT+AI" as a viable screening approach. China's health check-up environment presents three key advantages: First, LDCT delivers just 1/4-1/5 the radiation of standard abdominal CT, staying within ICRP safety guidelines (\<3mSv). Second, LDCT offers superior cost-effectiveness compared to CE-CT by eliminating contrast agent expenses. Third, China's extensive annual health check-up infrastructure provides an unparalleled foundation for widespread implementation. In the study, we will conduct a prospective, multicenter, observational cohort design targeting a health check-up population, utilizing the PANDA system to enhance LDCT for pancreatic cancer screening. Initially, PANDA analyzes the LDCT images of participants and provides interpretation results. Subsequently, a multidisciplinary team (MDT) will re-evaluate the cases with positive AI findings (including PDAC, pancreatic precursor lesions and benign lesion) and determine whether to recall the individuals: (1) Suspected PDAC and pancreatic precursor lesions are referred for hospital examination with diagnostic results collected; (2) Benign lesion cases receive personalized monitoring until endpoint events or study end; (3) Cases with positive AI findings but MDT-confirmed normal pancreatic issues receive at least one year of follow-up. If any abnormal results arise, management will transition to either plan (1) or (2). The primary outcome measures include pancreatic cancer detection rate, positive predictive value, consensus rate, and recall rate. Secondary outcome measures include the proportion of early-stage pancreatic cancers and resectable tumors. Safety indicators include the false positive rate, the proportion of unnecessary invasive procedures, and the proportion of unnecessary surgeries. This study aims to evaluate the effectiveness and safety of AI-powered LDCT in detecting pancreatic cancer within a health check-up population, offering a practical solution to improve public health and early diagnosis for pancreatic cancer.
RECRUITING
This study focuses on women aged 18 to 70 who require surgery for benign adnexal disease (removal of an ovarian cyst, ovary and/or fallopian tube). This is a randomised study, i.e. each woman will be randomly assigned the surgical technique used for the planned operation, either vNOTES or conventional transabdominal laparoscopy. Currently, there are no randomised clinical trials specifically investigating the impact on women's sexual quality of life after benign adnexal surgery compared to conventional transabdominal laparoscopy. Patients appear to be more reticent about the vaginal approach to surgery due to fear of possible alteration of their sexual activity afterwards. Indeed, their fears relate to the vaginal scarring that occurs during the vNOTES surgery. The vaginal scar could cause vaginal pain and pain during sexual intercourse, especially if there is a post-operative complication with the vaginal scar. The vaginal scar could also alter women's perception of their bodies during sexual intercourse. This study is necessary to answer these questions and increase women's acceptance of the vNOTES technique for benign adnexal surgery. In this way, women would benefit from the advantages of vNOTES without fearing an impact on their sexual quality of life. The primary objective of this study is to demonstrate that the vNOTES technique, although using the vagina as an entry route, does not significantly alter the quality of sexual life of women after benign adnexal surgery compared to conventional transabdominal laparoscopy. The secondary objectives of this study evaluate the effectiveness of vNOTES (impact on pain, length of stay after surgery and patient satisfaction), complications ( during surgery and up to 30 days after surgery), as well as the relationship between the need to cut the surgical specimen for extraction and the difficulty of microscopic analysis. All participants in the study, regardless of the surgical technique assigned to them, will complete questionnaires to assess their quality of sexual life before surgery and at 3 and 6 months after surgery. These are the FSFI (female sexual function), CSI-16 (couple satisfaction) and a self-created questionnaire on pain during sex (dyspareunia). These questionnaires will determine whether there is a difference in the women's quality of sexual life before and after surgery, as well as comparing the two surgical techniques. The participants' general and medical data will be collected at the time of study enrolment, during hospitalisation and at one month after surgery to assess the secondary objectives of the study.
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The aim of the study is to prospectively evaluate the value of pelvic MRI including diffusion- and perfusion-weighted sequences in the selected group of patients that have an undetermined ovarian mass at ultrasound.
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Ovarian cysts are common in women during childbearing period. Most cysts are normal functional cysts that typically resolve spontaneously and need no treatment. However, pathologic cysts such as endometriomas and dermoid may require surgical intervention.( For women of childbearing age with symptomatic ovarian cysts, laparoscopic cystectomy is the first-line surgical treatment for ovarian cysts because it has many advantages, including the benefits of ovarian-sparing surgery (with continued hormonal support and preservation of future fertility) and of minimally invasive surgery (including small incisions, quick recovery, and less pain). Laparoscopic ovarian cystectomy is the treatment of choice for benign ovarian tumors in the young, including mature cystic teratomas, endometriomas, and serous or mucinous cystadenomas. One of the greatest challenge during the surgery is stopping bleeding from the rest ovarian tissue. Electrosurgical energy is a commonly used technique to cut off bleeding from the remaining ovarian tissue during laparoscopic ovarian cystectomy, but it can increase time of operation , increase the risk of complications, and if used excessively, it can damage the soft tissues of the ovaries, and interfere with fertility . Electrosurgical units can be divided into two major types: monopolar and bipolar, monopolar system refers to current flow from one active electrode through the patient, who is entirely included in the circuit, and exists via dispersive electrode to the generator, but its usage can cause collateral injuries and thermal necrosis at the point of contact. In bipolar units, both active and return electrodes are housed within the same instrument; so, the current flows only through the tissue between the two blades of the electrode and return to the generator without passing through the whole body. Bipolar energy is safer than monopolar energy in terms of the risk of postoperative adhesions and the risk of over treatment that can lead to ovarian failure and also provide a significant postoperative resumption of the spontaneous ovulation and pregnancy. On the other hand, other hemostatic strategies have been investigated such as hemostatic sealants, which create a seal when applied to bleeding tissues. This process causes platelets to clump together and initiates the clotting cascade, obstructing blood flow. Other studies, including randomized controlled trials, have consistently demonstrated that hemostatic sealants are effective in stopping bleeding and reducing blood loss at many surgical sites. This empirical evidence demonstrates the potential of a hemostatic sealant as an effective alternative to electrosurgical energy, particularly in surgical situations that require strong hemostasis, such as laparoscopic ovarian cystectomy. Ovarian reserve is defined as the size and number of the ovarian follicle pools at any given time. Alternatively, it can be defined as the total ovarian follicle pool which is equal to the quiescent (primordial) follicles plus growing follicles. This reproductive potential is determined by the quiescent primordial follicles that can develop into primary, antral, and ovulating follicles. It can be estimated by several methods and the level of serum anti-Mullerian hormone (AMH) is considered one of the best endocrine markers . AMH is formed by the granulosa cells of active follicles (primary follicles, preantral follicles and small antral follicles) but not by quiescent primordial follicles. AMH regulates the process of follicle formation by controlling the number of primordial follicles that initiate the maturation process, thus preventing the exhaustion of the quiescent follicles.
RECRUITING
In women with endometrioma who plan to undergo laparoscopic ovarian cystectomy, surgical technique can influence postoperative ovarian function because of removal of normal ovarian tissue with ovarian cyst and damage to ovarian tissue during bleeding control after stripping of endometrioma. This study is designed to compare hemostatic sealant to suturing in terms of hemostatic function, safety and preservation of ovarian function. Ovarian function of all patients will be evaluated on pre op, post op 12 weeks, post op 48 weeks by measuring AMH and ovarian volume. And Hemostatic function will be evaluated by measuring serum hemoglobin, blood loss during operation, etc.
RECRUITING
To study which surgical technique offers better results in treating endometriomas in terms of ovarian reserve preservation. The 2 conservatives techniques used are: 1. The combined technique 2. CO2 laser vaporization only Ovarian reserve will be assessed by consecutive measurements of AMH serum levels before and after surgery.
RECRUITING
Endometriosis is a chronic gynecological disease that affects women of reproductive age, characterized by the abnormal growth of endometrial tissue outside the uterine cavity. It affects 5-10% of women of reproductive age (Becker et al., 2022) and is associated with infertility in 40% of cases (Coccia et al., 2008). Among its clinical forms, ovarian endometrioma is the most frequent, appearing in 15-45% of patients with endometriosis (Cranney et al., 2017). In addition to its impact on fertility, the main clinical manifestation of endometriosis is pain. Chronic pelvic pain caused by endometriosis can be disabling and even lead to work absenteeism, with a significant impact on the quality of life of affected patients, who often experience delayed diagnosis, making its management even more difficult and requiring a multidisciplinary approach (Horne \& Missmer, 2022). Currently, there is still no consensus on what should be the first-line treatment for ovarian endometrioma (Gordts \& Campo, 2019). However, cystectomy reduces ovarian reserve due to the removal of healthy ovarian tissue adjacent to the cyst wall-something that further worsens the reproductive prognosis in patients whose fertility is already diminished due to endometriosis per se (Alborzi et al., 2021; Martinez-Garcia et al., 2021). Moreover, despite surgical removal of the endometrioma, the recurrence rate is high, ranging from 15-30% (Jee, 2022). In recent years, there has been a shift toward more conservative treatments for the management of endometrioma, such as expectant management or aspiration and sclerosis (Garcia-Tejedor et al., 2020). Various authors have shown that ultrasound-guided aspiration and alcohol sclerosis may be a promising option, as concluded in the meta-analysis by Cohen et al., which found that recurrence rates were similar to those of laparoscopic management of ovarian endometrioma, but with fewer complications. Results in assisted reproductive technology are also better compared to surgical treatment in symptomatic women, particularly in those with low ovarian reserve (Zhang et al., 2022). Furthermore, other comparative studies between surgery and aspiration-sclerosis have shown that, although recurrence rates are similar, pregnancy rates are higher in patients treated with sclerosis, with the same complication rate and significantly lower costs (Garcia-Tejedor et al., 2020; Zhang et al., 2022). Currently, the first-line treatment in patients diagnosed with endometriosis is hormonal therapy through the use of hormonal contraceptives. However, its efficacy in managing endometrioma is lower, and therefore, there is no consensus on its indication for this specific form of endometriosis (Cranney et al., 2017). In patients with a desire for pregnancy, alternative approaches are sought that do not interfere with fertility. At present, this often involves proceeding with in vitro fertilization without treating the endometrioma first, followed by surgery if needed (Miquel et al., 2020). In addition to reproductive outcomes in patients affected by endometriosis, symptomatology and its consequent impact on quality of life have become highly relevant factors in treatment selection. Accordingly, specific pain scales and quality-of-life questionnaires have been developed to assess the impact on women affected by this condition. One such tool is the Endometriosis Health Profile scale, available in two versions (EHP-30 and EHP-5), designed by Dr. Stephen Kennedy and his team at the University of Oxford. It is a validated scale for assessing quality of life in patients with endometriosis and has been translated into nearly all languages (Jones et al., 2023; Bourdel et al., 2019). The main objective of this project is to conduct a comparative analysis of patients diagnosed with ovarian endometrioma who undergo alcohol aspiration and sclerosis versus patients managed expectantly. The outcomes to be evaluated include impact on quality of life, clinical improvement, pregnancy rate, and the need for subsequent surgery.
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