Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Diseases and Abnormalities at or Before Birth

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Overweight

Obesity

Congenital Abnormalities

Endometrial Neoplasms

Overnutrition

Nutrition Disorders

Body Weight

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Central Nervous System Depressants

All Drugs and Chemicals

Gastrointestinal Agents

Reproductive Control Agents

Anesthetics

Misoprostol

Recruits from the Bariatric Surgery Program will be interviewed by a study investigator prior to their bariatric surgery. If the patient consents to the procedure, then this will usually be a D\&C performed in one setting at the time of her bariatric surgery under general anesthesia. In the case where a patient is diagnosed with complex atypical endometrial hyperplasia or early endometrial prior to her bariatric surgery, an IUD device can be inserted at the time of her bariatric surgery.

For patients not undergoing bariatric surgery, an endometrial biopsy will be performed in the clinic or office setting. If the biopsy cannot be performed due to technical difficulty (cervical stenosis) or inadequate sampling, we will try again on a different day after a trial of vaginal misoprostol (Cytotec) 400 or 600 mcg per vagina the night before.

Recruits from the Bariatric Surgery Program will be interviewed by a study investigator prior to their bariatric surgery. During the interview, the purpose of the study will be explained as well as the surgical technique used for obtaining an endometrial sample. If the patient consents to the procedure, then this will usually be a D\&C performed in one setting at the time of her bariatric surgery under general anesthesia. In the case where a patient is diagnosed with complex atypical endometrial hyperplasia or early endometrial prior to her bariatric surgery, an IUD can be inserted at the time of her bariatric surgery.

For patients not undergoing bariatric surgery, an endometrial biopsy will be performed in the clinic or office setting using an endometrial suction catheter.

Endometrial Biopsy

Lisa Anderson, MD

The purpose of this study is to develop an endometrial biopsy screening program for endometrial cancer and its precursor lesions in overweight and obese women.

There is a BMI threshold at and above which optimal screening parameters exist for identifying endometrial cancer and its precursor lesions in overweight and/or obese women. Prevention, diagnosis and treatment of endometrial cancer and its precursor lesions in overweight and/or obese women offers substantial health benefits.

Screening for Endometrial Abnormalities in Overweight and Obese Women

St. Luke's-Roosevelt Hospital Center

Antineoplastic Agents

Dostarlimab

* Patients will receive four doses of TSR-042. The first dose is given 21 days prior to the first planned brachytherapy fraction. The second dose is given 21 (+3) days later, corresponding to the time of brachytherapy fraction #1. The third dose is given 21 (+3) days after dose 2, corresponding to the time of brachytherapy fraction #4. The fourth dose is given 21 (+3) days after dose corresponding to 1 weeks after brachytherapy fraction #6.
* Brachytherapy will consist of 6 weekly fractions of 6 Gy per fraction (total 36Gy)

-TSR-042 is administered intravenously via a 30-minute (-5-minute/+15-minute infusion window allowed) infusion

TSR-042

-This trial will include image-guided brachytherapy with three-dimensional (3-D) treatment planning and in cases where pelvic radiation is deemed appropriate by the treating radiation oncologist, external beam radiation therapy (EBRT) using intensity modulated radiation therapy (IMRT) technique.

Brachytherapy

-Prior to the start of treatment with TSR-042. If this biopsy yields insufficient tumor tissue, an archival sample may be requested, with Fraction 1 of brachytherapy, with Fraction 4 of brachytherapy

Endometrial biopsy

-Prior to the start of any treatment, at the time of brachytherapy fractions 1 and 4 (corresponding to endometrial biopsy), prior to fourth dose of TSR-042, 6 weeks after the completion of all protocol related therapy

Blood draw for immune response

Stephanie Markovina, M.D., Ph.D.

Premal Thaker, M.D.

David G Mutch, M.D.

Matthew A Powell, M.D.

Leslie S Massad, M.D.

Andrea R Hagemann, M.D.

Carolyn K McCourt, M.D.

Mary M Mullen, M.D.

Lindsay M Kuroki, M.D.

Julie K Schwarz, M.D., Ph.D.

Dino Khabele, M.D.

Jin Zhang, Ph.D.

Yi Huang, M.S.

Jessika Contreras, M.D.

Stephanie Markovina, M.D, Ph.D.

Patients with inoperable endometrial cancer have limited treatment options. PD-L1 expression is common in endometrial cancers and RT induces tumor and systemic changes that induce the immune system. The purpose of this trial is to evaluate anti-PD-1/PD-L1 axis therapy in conjunction of standard of care RT for patients with inoperable endometrial cancer in order to establish the safety and efficacy of inducing an anti-tumor immune response.

TSR-042 in Addition to Standard of Care Definitive Radiation for Inoperable Endometrial Cancer

A Phase I Study of PD-1 Inhibition With TSR-042 in Addition to Standard of Care Definitive Radiation for Inoperable Endometrial Cancer

PFS is defined as the time from last TSR-042 administration to disease progression or death. Response and progression will be evaluated in this study in a qualitative fashion by symptoms (such as bleeding, abdominal or pelvic pain, changes of bowel or bladder habits lasting more than two weeks), clinical exam and/or evidence of disease on imaging by RECIST 1.1 as not all patients will have measurable disease at baseline on imaging. Persistent/recurrent clinical disease will be confirmed by biopsy whenever possible.

Tesaro, Inc.

Washington University School of Medicine

Behaviors and Mental Disorders

Wounds and Injuries

Anxiety Disorders

Hyperplasia

Endometrial Hyperplasia

The study is planned to consist of two groups as experimental and control.

No intervention will be given to the control group.

In the study, the experimental group was given a round, compressible ball for stress ball application and it was planned to squeeze this ball in their hands as often as they wanted during anaesthesia and endometrial biopsy application. The endometrial biopsy procedure is a procedure that usually takes between 8-10 minutes. The results will be evaluated considering these average times. As it is foreseen that individuals may experience the most intense anxiety and stress during anaesthesia and biopsy, it was preferred to cover this time period.

stress ball

In the study, the no intervention group ( control group) will receive no intervention and blood pressure and stress measurements will be made with routine care and nursing interventions.

control

The aim of this study is to determine the effect of stress ball application on the anxiety level during the endometrial biopsy procedure.

This research is planned as a randomised controlled study. Place and time of the research: The research is planned with patients who will undergo endometrial biopsy procedure in Zonguldak Obstetrics and Gynecology Hospital affiliated to the Ministry of Health.

While there are various experimental studies in the literature on the effect of stress ball on anxiety during many painful procedures, there is no study in the literature on the effect of stress ball on anxiety level during endometrial biopsy procedure (Akarsu, Kuş \& Akarsu 2021, Genç 2021Nurdina, Anggraini \& Novyanda 2022, Srivarsan, Sridevi \& Preetha 2021, Yanks et al. 2018,) In this study, it was aimed to evaluate the effect of stress ball application on anxiety level during endometrial biopsy procedure

Endometrial biopsy is a simple, inexpensive and effective method to rule out endometrial cancer.

Endometrial biopsy is the gold standard method in the diagnosis of endometrial pathologies and is widely used in gynaecological practice. Although endometrial biopsy is a common gynaecological procedure, its psychological effects have not been emphasised. In particular, the potential stress before and during the procedure, exposure to the test and the waiting time for the biopsy result have been mostly ignored. Patients with bleeding in the postmenopausal period already present to the physician with anxiety, and when it is stated that a biopsy should be taken for diagnosis, their anxiety increases due to both the procedure itself and the possibility of an unfavourable outcome at the end of the procedure.

While there are various experimental studies in the literature on the effect of stress ball on anxiety during many painful procedures, there is no study in the literature on the effect of stress ball on anxiety level during endometrial biopsy procedure .In this study, it was aimed to evaluate the effect of stress ball application on anxiety level during endometrial biopsy procedure.

Effect of Stress Ball Use on Anxiety Level During Endometrial Biopsy Procedure

The study is planned to be completed within 1 year and published as a publication within 3 years.

The state and trait anxiety scale consists of two parts and contains a total of 40 questions. The first 20 questions of the scale measure state anxiety, and the last 20 questions measure trait anxiety. The results of the state anxiety section of the scale will be used in this research. The State Anxiety Scale requires the individual to describe how he or she feels at a particular moment and under certain circumstances.

It constitutes another parameter for measuring the stress level.

The aim is to determine the changes caused by stress on blood pressure before and after the procedure.

Zonguldak Bulent Ecevit University

Dr, Principle İnvestigator

Skin and Connective Tissue Diseases

Leiomyoma

Hemorrhage

Myofibroma

Uterine Hemorrhage

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Group of patients in which office hysteroscopy will be performed prior to endometrial biopsy

Group of patients in which endometrial biopsy will be performed prior to office hysteroscopy

Office hysteroscopy is a procedure performed in the office in which a flexible hysteroscope is inserted into the uterine cavity. The patient is positioned in a dorsal lithotomy position and teh cervix is visualized with a speculum. Normal saline is used to distend the cavity, and the hysteroscope is used to visualize any abnormalities within the cavity.

Office hysteroscopy

An endometrial biopsy is a procedure in which a pipelle instrument is inserted into the uterine cavity and suction from the pipelle is used to obtain endometrial tissue. This is performed with the patient in the dorsal lithotomy position and a speculum is used to visualize the cervix.

Anthony Imudia, MD

This study will look at the optimal order in which to perform concurrent office hysteroscopy and endometrial biopsy in female patients who present for evaluation of abnormal uterine bleeding at a fibroid and endometriosis treatment center.

This will be a prospective single blinded randomized control trial to determine whether the order of performance of office hysteroscopy (OH) and endometrial biopsy (EMB) during the same office evaluation for abnormal uterine bleeding affects the patient's pain perception. We also intend to investigate whether the order of the procedures affects the adequacy of the endometrial sample, duration of the procedure, and optimal visualization of the uterine cavity. We hypothesize that performing EMB prior to OH will result in higher patient pain scores.

Included patients will be all consecutive female patients ages 18-70 presenting to the University of South Florida Center for Endometriosis and Fibroid Treatment (CFERT) for evaluation of abnormal uterine bleeding or uterine fibroids.

Patients will be randomly assigned to have either OH followed by EMB or EMB followed by OH as part of their clinical assessment of AUB/uterine fibroid based on clinical indication. The patients will be informed about the two indicated procedures by their clinical provider but will be blinded to the order of performance. The healthcare provider/investigator will be aware of the order in which the procedures are assigned and to be performed. Patients will be consented to participate in the study prior to the procedure by the study team on the day the indicated procedures are scheduled in CFERT. The healthcare provider performing the procedure will open an unlabeled envelope, within which there will be a piece of paper indicating which procedure is to be performed first. This will then be recorded in the study log. The study log will include enrolled patients, assigned study number which will range from 001 to the minimum number of patients required for the study as indicated by sample size calculation.

At the end of the procedures, patient will be asked to describe their pain perception based on Visual analogue scale (VAS) from 0-10. The adequacy of the endometrial sample will be determined from the pathology report. The duration of the entire procedures (min) will be timed using a stopwatch from the time of insertion of the hysteroscope/Pipelle catheter in the external cervical canal to removal of the instruments. A panoramic picture of the endometrial cavity will be taken and will be given to a blinded independent reviewer to determine the adequacy of visualization based on 3 point scoring system (fair, good and excellent). Fair visualization will be defined as no tubal ostia visualized; good will be defined as both tubal ostia identified but only able to visualize 180 degrees of panorama; excellent visualization will be defined as visualizing bilateral tubal ostia and having a clear image of the uterine cavity in 360 degrees of panorama.

Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy

Office Based Evaluation of Patients Presenting With Abnormal Uterine Bleeding and/or Uterine Fibroids With Concurrent Office Hysteroscopy and Endometrial Biopsy; Does the Order Matter?

After the procedures are performed, the patient will be asked to describe their pain perception based on Visual analogue scale (VAS) from 0-10

The adequacy of the endometrial sample will be determined from the pathology report.

The duration of the entire procedures (min) will be timed using a stopwatch from the time of insertion of the hysteroscope/Pipelle catheter in the external cervical canal to removal of the instruments.

A panoramic picture of the endometrial cavity will be taken and will be given to a blinded independent reviewer to determine the adequacy of visualization based on 3 point scoring system (fair, good and excellent). Fair visualization will be defined as no tubal ostia visualized; good will be defined as both tubal ostia identified but only able to visualize 180 degrees of panorama; excellent visualization will be defined as visualizing bilateral tubal ostia and having a clear image of the uterine cavity in 360 degrees of panorama.

University of South Florida

Polyps

Menorrhagia

Endometrial sample obtained using the H Pipelle

Endometrial sample obtained with standard Pipelle

Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy

Adam Magos, BSc MD FRCOG

The investigators have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. The investigators wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy.

We have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. We wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy in terms of biopsy adequacy, the time taken to obtain a biopsy and patient experience.

Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy

Royal Free Hampstead NHS Trust

Adam Magos BSc MB BS MD FRCOG, Consultant Gynaecologist

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Endocrine System Diseases

Menstruation Disturbances

Catheter utilized in dual role: sonohysterography and endometrial biopsy

SonoBiopsy Catheter

Endometrial sample obtained without the assistance of sonohysterography

Endometrial biopsy catheter

Ricardo Mastellari, MD

To assess the adequacy of an endometrial biopsy sample obtained using sonohysterography.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Screening for Endometrial Abnormalities in Overweight and Obese Women	NCT01922778	Endometrial Can...	Endometrial Bio...	18 Years - 65 Years	St. Luke's-Roosevelt Hospital Center
TSR-042 in Addition to Standard of Care Definitive Radiation for Inoperable Endometrial Cancer	NCT03955978	Endometrial Can... Cancer of the E...	TSR-042 Brachytherapy Endometrial bio... Blood draw for ...	18 Years -	Washington University School of Medicine
Effect of Stress Ball Use on Anxiety Level During Endometrial Biopsy Procedure	NCT06171581	Biopsy Wound Endometrial Hyp... Endometrial Neo...	stress ball control	18 Years -	Zonguldak Bulent Ecevit University
Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy	NCT02472184	Uterine Fibroid... Vaginal Bleedin...	Office hysteros... Endometrial bio...	18 Years - 70 Years	University of South Florida
Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy	NCT00755651	Abnormal Uterin...	Endometrial bio...	20 Years - 80 Years	Royal Free Hampstead NHS Trust
Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology	NCT01969396	Menorrhagia Endometrial Neo... Polycystic Ovar... Uterine Neoplas...	SonoBiopsy Cath... Endometrial bio...	18 Years -	Cook Group Incorporated
Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy	NCT02472184	Uterine Fibroid... Vaginal Bleedin...	Office hysteros... Endometrial bio...	18 Years - 70 Years	University of South Florida

Spots Global Cancer Trial Database for endometrial biopsy