Protocol Title: Quality of life and cost- effectiveness of postpartum clinics specializing in obstetric anal sphincter injuries (OASI)

Currently Enrolling

This is a study that will gather information from patients who have experienced Obstetric Anal Sphincter Injuries (OASI), which are serious tears that can occur during childbirth. The study will look at how well general quality-of-life surveys work for these patients and assess the cost- effectiveness of postpartum clinics specializing in OASI care up to 13 months postpartum. 

To enroll in this study at USF Health, please contact Kaitlyn Tibbetts at (813) 259- 0655.

Protocol Title: Pregnancy and Postpartum Pelvic Health Clinic Patient Registry

Currently Enrolling

This is a prospective observational registry that serves to collect information on the clinical course of pelvic floor function up to five years postpartum in women who experience Obstetric Anal Sphincter Injuries (OASI).

To enroll in this study at USF Health, please contact Kaitlyn Tibbetts at (813) 259-0655.

Protocol Title: Feasibility of pelvic floor muscle training with a digital therapeutic motion-based device (Leva Device) in a postpartum population

Enrolling Soon

This prospective study aims to assess the feasibility of postpartum use of a digital therapeutic motion-based device for pelvic floor muscle strengthening. To enroll in this study at USF Health, please contact Kaitlyn Tibbetts at (813) 259-0655.

Protocol Title: Development and Validation of Parallel Aneuploidy and Recessive Surveillance via Noninvasive Prenatal Screening (parsNIPS)

Currently Enrolling

This retrospective and prospective study will collect fetal prenatal diagnostic samples and blood samples from the mother and, as available, the father to perform simultaneous fetal screening for chromosomal aneuploidy and severe recessive conditions. The aim of this study is to develop and validate parsNIPS to screen a fetus for the common aneuploidies and a set of recessive conditions in a single test. 

To enroll in this study at USF Health, please contact Maura Gongora at (813) 259-8617.

Protocol Title: Collection of Tissue, Biological fluids, Blood Specimens and Clinical Data from Patients with Benign Gynecologic Conditions or Infertility.

Currently Enrolling

The goal of this study is to better characterize the disease process and treatment of benign gynecologic conditions such as uterine fibroids, endometriosis, and infertility. This study plans to collect clinical data and specimens (tissues and biological fluids) from patients with the aforementioned pathologies in order to perform comprehensive clinical and basic science research with the purpose of discovering new and effective therapies. 

To enroll in this study at USF Health, please contact Kaitlyn Tibbetts at (813) 259-0655.

Protocol Title: Screening Study to Determine HLA Type, HLA Loss of Heterozygosity Status and Tumor Antigen Expression in Participants with Locally Advanced (Unresectable) or Metastatic Solid Tumors

Currently Enrolling

The purpose of this screening study is to collect samples to conduct HLA genotyping, HLA Loss of Heterozygosity (LOH), and expression of Tumor-associated Antigens (TAA) testing. These results will be used to determine if subjects meet the eligibility criteria for these parameters and could potentially be enrolled in a TScan clinical treatment study.

For more information, please visit the website at https://clinicaltrials.gov/study/NCT05812027?term=NCT05812027&rank=1 or https://www.tscan.com/for-patients/solid-tumors/.

To enroll in this study at USF/TGH, please contact Kathleen Murillo at (813) 844-4151. 

Protocol Title: Cancer Moonshot Biobank Research Protocol

Currently Enrolling

This trial collects multiple tissue and blood samples, along with medical information, from cancer patients. The "Cancer Moonshot Biobank" is a longitudinal study that collects and stores samples and information over time, throughout the course of a patient's cancer treatment. By looking at samples and information collected from the same people over time, researchers hope to better understand how cancer changes over time and over the course of medical treatments.

For more information, please visit the website at https://moonshotbiobank.cancer.gov/ or https://clinicaltrials.gov/study/NCT04314401?term=NCT04314401&rank=1.

To enroll in this study at USF/TGH, please contact Brittney Short at (813) 844-4151. 

Protocol Title: Observational basket trial to collect tissue to train and validate a live tumor diagnostic platform (CYBRID-02)

Enrolling Soon

In this observational clinical basket trial, participants will be recruited and their actual clinical response (using RECIST 1.1) to CPIs across five solid tumors (lung, head/neck, bladder, kidney, and skin) will be compared to the platform's predictive Artificial Intelligence (AI) score that is based on RNA, clinical data, and 3D microscopy images. The sensitivity and specificity of the platform's score will be determined and compared to current diagnostic methods for CPIs like PDL1, MSI, and TMB.

For more information please visit https://clinicaltrials.gov/study/NCT05520099?term=CYBRID-02&rank=1. 

To enroll in this study at USF/TGH, please contact Brittney Short at (813) 844-4151. 

Protocol Title: The CARIS Biorepository Research Protocol

Currently Enrolling

The Biorepository for Caris Life Sciences is designed for the purpose of making quality biospecimens and associated clinical data available for research studies related to advancing precision medicine and improving care for patients.The Caris Biorepository is a repository of prospectively collected biological specimens and associated clinical and demographic data gathered from multiple sources to be stored, used, and shared for research. Caris Life Sciences will maintain the data and specimens and will control access to and use of the information and specimens by multiple individuals for multiple purposes which may evolve over time. 

For more information, please visit https://clinicaltrials.gov/study/NCT01499394?term=TCBIO-001-0710&rank=1. 

To enroll in this study at USF/TGH, please contact Brittney Short at (813) 844-4151.

Procol Title: Translational Medicine: Discovery and Evaluation of Biomarkers/Pharmacogenomics for the Diagnosis and Personalized Management of Patients

Currently Enrolling

Researchers are trying to collect tissue and blood and other body fluid samples These samples will be used immediately or stored in a ABiobank@. Researchers will use them to try to develop new drugs or treatments or tests, as well as to study how individual differences may affect how drugs work.

To enroll in this study at USF/TGH, please contact Brittney Short at (813) 844-4151. 

Protocol Title: University of South Florida/Tampa General Hospital Tissue Biorepository/Clinical Proteomic Tissue Analysis Consortium Tissue Source Site

Currently Enrolling

The primary goal of this biorepository will be to comprehensively collect high-quality specimens (e.g. tissue, blood, urine, and ascites) as tissues are removed from human subjects during clinically indicated surgery and create a searchable database of clinical and outcome demographics suitable for assessing the clinical significance of specific biologic events.

To enroll in this study at USF/TGH, please contact Brittney Short at (813) 844-4151.

Caris Retrospective Real-world Outcomes-Associated Database, Multi-site Precision Oncology AllianceTM Protocol (ROADMAP)

Currently Enrolling 

This repository is a multi-center, outcomes study designed to retrospectively collect data on the demographics, presentation, diagnosis, treatment, and outcomes of subjects utilizing Caris profiling services for the treatment of cancer. 

For more information please visit https://clinicaltrials.gov/study/NCT03326479?term=COE-002-1116&rank=1#study-overview. 

To enroll in this study at USF/TGH, please contact Brittney Short at (813) 844-4151. 

Protocol Title: A Comparative Effectiveness Trial of Oral Metformin versus Injectable Insulin for the Treatment of Gestational Diabetes

Start-up/pending

This study will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. Participants and their children will be followed through delivery to two years postpartum.

For more information please visit https://www.pcori.org/research-results/2023/decide-comparative-effectiveness-trial-oral-metformin-versus-injectable-insulin-treatment-gestational-diabetes or https://clinicaltrials.gov/study/NCT06445946?term=NCT06445946&rank=1.

To enroll in this study at USF Health, please contact Hillary Henry at (813) 259-8685.

Protocol Title: VMS IDN - Understanding the clinical, humanistic, and economic burden of menopausal symptoms: an observational study in menopausal women.

Start-up/pending

The aim of this study is to better understand, using real-world data, the extent of the burden of menopausal symptoms, to evaluate the clinical, humanistic, and economic burden of VMS, sleep, and mood disorders in menopausal women, and to evaluate current treatment modalities and assess the extent to which the burden is addressed or controlled.

To enroll in this study at USF Health, please contact Hillary Henry at (813) 259-8685.

Protocol Title: Fetoscope Assisted Procedure for TTTS Protocol

Currently Enrolling

This prospective study aims to provide the participants with detailed information on fetoscopic procedures of selective laser Twin-to-Twin transfusion syndrome (TTTS). The instrument used for the treatments is approved as a Humanitarian Use Device. 

To enroll in this study at USF Health, please contact Hillary Henry at (813) 259-8685.

Protocol Title: Database Evaluating Use and Safety of Fetoscope Assisted Procedures

Currently Enrolling

The study is a prospective observational study that aims to document our Centers experience with the use of Fetoscopy in the treatment of fetal conditions amenable to minimally invasive therapy, specifically, selective laser treatment of Twin-twin transfusion syndrome, laser excision of amniotic band syndrome, bipolar umbilical cord coagulation of Acardiac twins with Twin-reversed arterial perfusion (TRAP) sequence, the use of the fetoscope to guide ablation of posterior urethral valves in cases of bladder outlet obstruction and Fetoscopic endoscopic tracheal occlusion (FETO) in cases of congenital diaphragmatic hernias with poor prognosis.

To enroll in this study at USF Health, please contact Hillary Henry at (813) 259-8685.

Protocol Title: North American Fetal Therapy Network Complicated Monochorionic Twin Pregnancy Registry

Currently Enrolling

The study is a prospective observational study that aims to determine the rate of maternal complications and pregnancy outcomes in complicated Monochorionic Twin pregnancies. Additionally, the goal of this study is to determine the optimal frequency and type of monitoring and the optimal timing and indications for delivery for monoamniotic twin pregnancy. 

To enroll in this study at USF Health, please contact Hillary Henry at (813) 259-8685.