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Pelvic Neoplasms clinical trials

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NCT ID: NCT06469229 Not yet recruiting - Bladder Cancer Clinical Trials

Performance Evaluation of Urine DNA Methylation Testing for the Detection of Urothelial Carcinoma in Patients With Hematuria

Start date: July 1, 2024
Phase:
Study type: Observational

Background Urothelial carcinoma (UC) is the most common malignancy of the urinary system. Hematuria is a significant clinical manifestation of UC, often diagnosed through invasive procedures. Urine DNA methylation testing is a promising non-invasive method for early UC detection. Objectives To evaluate the sensitivity and specificity of urine DNA methylation testing for detecting UC in patients with hematuria, using standard clinical and pathological diagnoses as the gold standard. We also aim to investigate the association between preoperative urine DNA methylation status and prognosis in UC patients. For non-UC patients: Follow up for one year to assess the risk of UC development based on preoperative urine DNA methylation status. Sample Size Calculation Expected sensitivity: 86% Expected specificity: 90% Significance level (Alpha): 0.05 Total participants needed: 1053 (adjusted for 5% dropout rate, 1109 participants will be recruited). Study Procedure Enrollment and Sample Collection: Screen patients, obtain consent, collect urine samples. Blinding and Testing: Blinded sample processing and DNA methylation testing. Unblinding and Analysis: Statistical analysis of sensitivity and specificity. Reporting: Compilation and consolidation of clinical trial reports. We anticipate that urine DNA methylation testing will show high sensitivity and specificity for UC diagnosis in patients with hematuria, providing valuable non-invasive diagnostic information and improving patient outcomes.

NCT ID: NCT06465069 Not yet recruiting - Prostate Cancer Clinical Trials

A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors

NEXUS-01
Start date: June 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

NCT ID: NCT06458725 Not yet recruiting - Rectum Cancer Clinical Trials

Assessment of DW-MRI Measures : Reproducibility and Repeatability in Pelvic Imaging on MR-Linac With Healthy Volunteers

PILLAR
Start date: June 13, 2024
Phase: N/A
Study type: Interventional

This study evaluates the reliability of functional MRI measurements in pelvic disease through quantifying repeatability and reproducibility, using healthy volunteers. The aim is to provide insights into the consistency of results across sessions and observers, informing the trustworthiness of functional MRI in assessing pelvic disease and particularly rectal cancers and guiding protocol optimization.

NCT ID: NCT06427993 Not yet recruiting - Bladder Cancer Clinical Trials

Urine DNA Methylation Detection for Hematuria Evaluation

Start date: June 15, 2024
Phase:
Study type: Observational

Background: Hematuria, a common symptom of urinary system diseases, can result from various causes including infection, stones, trauma, and tumors. Urothelial carcinoma (UC), the most common malignancy of the urinary system, often presents with hematuria. Current diagnostic methods like urine cytology and cystoscopy have limitations in sensitivity and specificity, and cystoscopy is invasive. DNA methylation biomarkers offer potential for non-invasive UC detection, improving diagnostic accuracy in hematuria patients. Objective: This study aims to evaluate the diagnostic performance of DNA methylation biomarkers in detecting UC in patients with hematuria. Methods: This prospective pilot study will involve collecting preoperative urine samples from hematuria patients for DNA methylation testing using MSRE-qPCR. Sample size calculation was based on an assumed 25% prevalence of UC in hematuria patients, resulting in a total of 71 participants after accounting for a 20% dropout rate. Sensitivity, specificity, and diagnostic performance will be assessed using ROC curves. Conclusion: This study seeks to validate the effectiveness of urine DNA methylation testing for UC detection in hematuria patients, providing a basis for its clinical application and informing the design of larger future studies.

NCT ID: NCT06418243 Not yet recruiting - Pelvic Tumor Clinical Trials

Contribution of 3D Modeling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors

3D-PEDSURG
Start date: June 2024
Phase:
Study type: Observational

This study's purpose is the comparison of the automatically segmented 3D model to the reference manual segmentation, based on the Dice precision index. It is implemented by making parents' patients, surgeons and surgical helpers answer specific questions comparing 3D images to usual 2D images of the patient's tumor.

NCT ID: NCT06187103 Not yet recruiting - Breast Cancer Clinical Trials

Evaluation of Improved Onboard Patient Imaging

Start date: May 2024
Phase: N/A
Study type: Interventional

The primary objective of radiation therapy is to deliver a therapeutic dose of radiation precisely to the target while minimizing exposure to healthy surrounding tissues. Image-guided radiation therapy (IGRT) involves acquiring cone beam computed tomography (CBCT) scans just before or during treatment sessions. By comparing the CBCT images with the reference images from the treatment planning process, clinicians can make necessary adjustments to ensure precise targeting and account for any changes that may have occurred since the initial planning. Conventional CBCT technology is, however, limited by several factors including long acquisition times that result in motion artifacts in the image, smaller fields of view that limit the volume of anatomy that can be imaged, poor image quality that limits soft tissue visibility, and artifacts created by dense metal implants. This study will evaluate a novel CBCT imaging solution ("HyperSight") that has the potential to address the challenges of conventional CBCT.

NCT ID: NCT05832385 Not yet recruiting - Anorectal Cancer Clinical Trials

Effects of Different Radiation Dosimetry for Anorectal Function of Patients With Pelvic Cancer

Start date: May 15, 2023
Phase:
Study type: Observational

In this prospective, open, multicenter, multi-arm, observational controlled study, the investigators investigated the impact of different pelvic radiation doses of anal cancer and rectal cancer patients on the dynamic changes of anal function, and analyzed the correlation between the changes of anal function and the score of anal incontinence in the radiation dose≤50Gy group and >50Gy group. The study population includes 124 patients with anal canal cancer or rectal cancer who have received sphincter preservation treatments (including radiochemotherapy), aged from 18 to 75 years old undergoing sphincter preservation treatments at The Sixth Affiliated Hospital, Sun Yat-sen University and Nanfang Hospital, Southern Medical University. The primary outcome is the average resting pressure of anal sphincter. The secondary outcomes are maximum anal sphincter contraction pressure and Wexner continence score. Evaluations will be carried out at the following stages: baseline (T1), after radiotherapy or chemotherapy (before surgery, T2), after surgery (before closing the temporary stoma, T3), and at follow-up visits (every 3 to 6 months, T4, T5……). Follow-up for each patient will be at least 2 years.

NCT ID: NCT05633134 Not yet recruiting - Pelvic Tumor Clinical Trials

Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The main purpose of this study is to assess the efficacy of precision preoperative embolization in decreasing operative blood loss, reducing surgical complications in pelvic tumor surgery. Furthermore the study aims at describing the vascularity in a series of pelvic tumors, and to correlate this with perioperative blood loss.

NCT ID: NCT05258383 Not yet recruiting - Breast Cancer Clinical Trials

Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests

ELISA
Start date: May 15, 2023
Phase:
Study type: Observational

In image-guided radiotherapy (IGRT), the repeated and increasingly intensive use of on-board positioning imaging, using 2D or 3D Mega-Volt (MV) or kilo-Volt (kV) imaging devices (cone-beam or CBCT scanners), is leading the international medical community to question the potential impact of these additional doses delivered to the patient, especially in at-risk populations such as children and young adults. The doses delivered to the patient by positioning imaging are still relatively unknown, due to the lack of experimental means and software available in clinical routine to easily and accurately evaluate these doses. The main objective is to estimate by personalized Monte Carlo calculation the physical doses delivered to the patient's organs by the onboard imaging systems during their radiotherapy treatment. The obtained imaging doses will be compared according to different irradiation scenarios commonly used in clinical routine as well as according to the treated location.

NCT ID: NCT05145972 Not yet recruiting - Clinical trials for Efficacy of Adding Lidocaine 10% to Phenol in Superior Hypogastric Plexus Neurolysis

Efficacy of Adding Lidocaine 10% to Phenol in Ultrasound Guided Superior Hypogastric Plexus Neurolysis in The Management of Pelvic Cancer Pain

Start date: December 30, 2021
Phase: Phase 2
Study type: Interventional

The superior hypogastric plexus (SHP) is a complex nervous collection located at the lumbosacral region below the level of the aortic bifurcation at the level of the lower third of the fifth lumbar vertebral body and upper third of the first sacral vertebral body at the sacral promontory Neurolytic agents, such as alcohol and phenol have been used to ablate peripheral nerves to treat pain and spasticity . These agents were nonspecific for neuronal tissue and complications have been seen involving damage to surrounding soft tissue (skin, muscle, vascular) and pain on alcohol injection Lidocaine has been demonstrated to be neurotoxic in high concentrations at 10% and can be used as a neurolytic agent with no effect on motor function, muscle state, or surrounding tissue rather than other neurolytic.