Neoplasms

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Skin and Connective Tissue Diseases

Rare Diseases

Leiomyoma

Myofibroma

Sarcoma

Fibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Soft Tissue Sarcoma

Uterine Sarcoma

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Echo-guided uterine biopsy will be performed by a specialized radiologist by transvaginal and exclusive transuterine approach. 4 to 5 samples will be made.

Local anesthesia will be performed. A pain assessment will be performed during the biopsy (visual or verbal scale).

Echo-guided uterine biopsy

Frédéric GUYON, MD

Simone MATHOULIN-PELISSIER, MD, PhD

Denis QUERLEU, MD, PhD

This is a prospective multi-center interventional study that will be performed in an effort to assess the diagnostic accuracy performance of preoperative vaginal ultrasound-guided biopsy (VUGB) to detect the exact histology of uterine tumors and thereafter triage cases being eligible for morcellation during laparoscopic resection. Ten tertiary French centers will participate in the present study.

Prior to carrying out the research, the informed consent of the person must be obtained after being informed of the purpose of the research, its conduct and duration, benefits, potential risks and constraints of the study.

During the inclusion check-up, exams must be performed within 30 days before the guided echo biopsy: clinical examination, gynecological examination, pain assessment (visual or verbal scale), biological and radiological assessment (Doppler ultrasound Pelvis and MRI pelvis).

The echo-guided biopsy will be performed by a specialized radiologist by transvaginal and exclusive transuterine approach. Local anesthesia will be performed. A pain assessment will be performed during the biopsy (visual or verbal scale).

Between the biopsy and the procedure, the patient will be reviewed by the investigating surgeon to check the outcome of the biopsy, any pain or complications of the biopsy.

The surgical procedure will be performed by laparotomy and will consist of an extra-facial hysterectomy without fragmentation of the surgical specimen (extraction technique "in block"). During the procedure, the investigating surgeon will perform a description of the abdominal and pelvic cavity and perform a block excision of the tumor.

At one month of the surgery, patient will be reviewed by the investigating surgeon for a postoperative visit with clinical examination, gynecological and histopathological results.

Thereafter, the follow-up of the patients will be carried out according to the standards of care according to the histopathological results.

Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors (BIOPSAR)

Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors

Sensitivity is the proportion of patients with malignant/STUMP result on the local reading of biopsy (index test) divided by the number of patients with malignant/STUMP result on the local reading of surgical specimen (reference standard). Primary outcome assessment will be based on the local reading.

Specificity is the proportion of patients with benign result on the local reading of biopsy divided by the number of patients with benign result on the local reading of surgical specimen.

Accuracy is the proportion of patients with true results: true positives (TP) + true negatives (TN) divided by number of cases. Accuracy ranges from 0 (100% false positives and false negatives) to 1 (100% true positives and true negatives). Assessment will be based on the local reading.

Youden's index is defined as sensitivity+specificity-1. The maximum value of the Youden index is 1 (perfect test) and the minimum is 0 when the test has no diagnostic value. Assessment will be based on the local reading.

PPV is the proportion of patients with malignant/STUMP results on the local reading of biopsy and surgical specimen (true positives) divided by the number of patients who might or might not have malignant/STUMP results (True positives+False positives).

NPV is the proportion of patients with benign results on the local reading of biopsy and surgical specimen (true negatives) divided by the number of patients who might or might not have benign results (True negatives+ False negatives)

Sensitivity is the proportion of patients with malignant/STUMP result on the centralized review of biopsy (index test) divided by the number of patients with malignant/STUMP result on the centralized review of surgical specimen (reference standard).

Specificity is the proportion of patients with benign result on the centralized review of biopsy divided by the number of patients with benign result on the centralized review of surgical specimen.

Accuracy is the proportion of patients with true results: true positives (TP) + true negatives (TN) divided by number of cases. Accuracy ranges from 0 (100% false positives and false negatives) to 1 (100% true positives and true negatives). Assessment will be based on the centralized review by an expert pathologist.

Youden's index is defined as sensitivity+specificity-1. The maximum value of the Youden index is 1 (perfect test) and the minimum is 0 when the test has no diagnostic value. Assessment will be based on the centralized review by an expert pathologist.

PPV is the proportion of patients with malignant/STUMP results on the centralized review of biopsy and surgical specimen (true positives) divided by the number of patients who might or might not have malignant/STUMP results (True positives+False positives).

NPV is the proportion of patients with benign results on centralized review of biopsy and surgical specimen (true negatives) divided by the number of patients who might or might not have benign results (True negatives+ False negatives).

Sensitivity is the proportion of patients with malignant/STUMP result on imaging divided by the number of patients with malignant/STUMP result on the local reading of surgical specimen (reference standard).

Specificity is the proportion of patients with benign result on imaging divided by the number of patients with benign result on the local reading of surgical specimen.

Accuracy is the proportion of patients with true results: true positives (TP) + true negatives (TN) divided by number of cases. Accuracy ranges from 0 (100% false positives and false negatives) to 1 (100% true positives and true negatives).

Youden's index is defined as sensitivity+specificity-1. The maximum value of the Youden index is 1 (perfect test) and the minimum is 0 when the test has no diagnostic value.

PPV is the proportion of patients with malignant/STUMP results on imaging and surgical specimen (true positives) divided by the number of patients who might or might not have malignant/STUMP results (True positives+False positives).

NPV is the proportion of patients with benign results on Imaging and surgical specimen (true negatives) divided by the number of patients who might or might not have benign results (True negatives+ False negatives)

Cohen's Kappa coefficient. kappa coefficient values greater than 0.75 correspond to acceptable reproducibility.

The minimum value is 0 and the maximum value is 10. A high score of pain indicates a high level of pain.

Complications related to biopsy will be evaluated after biopsy.

Adverse events will be evaluated at inclusion, on the day of the biopsy and after the biopsy.

PFS is defined as the time interval between the date of surgery and the date of progression and/or death whichever occurs first

OS is defined as the time interval between the date of surgery and the date of death (of any cause).

GIRCI SOHO

Institut Bergonié

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Carcinoma

Neoplasm Metastasis

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Uterine Neoplasms

Endometrial Neoplasms

Pelvic Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

All consecutive patients (\> 18 years) undergoing a tru-cut biopsy at the participating centers during the study periof will be eligible for inclusion in the study.

All biopsies will be performed by trained operators in gynecologic ultrasound and tru-cut biopsies. Tissue samples will be assessed by experienced pathologists, dedicated in gynecologic oncology. Data will be collected by reviewing patients' electronic medical file including data concerning further treatment-strategy and pathology reports. Patients' level of pain and overall experience will be assessed by an independent investigator not present during biopsy. This will be performed from 0-72h after the biopsy using a numeric rating scale (0-100). Safety and complication-rate will be assessed by both using the collected data and via postprocedural assessment and by phone after six weeks. Inclusion and exclusion criteria can be found elsewhere.

Tru-cut biopsies can collect tissue specimens via a needle of 18G A tru-cut biopsy can be performed under the guidance of different imaging modalities including ultrasound

Ultrasound guided tru-cut biopsy

Wouter Froyman, MD, PHD

Stefan Timmerman, MD

Wouter Froyman, MD, PhD

Daniela Fischerova, MD, PHD

Antonia Carla Testa, MD, PHD

Elisabeth Epstein, MD, PHD

In a transvaginal tru-cut biopsy, guided by ultrasound, a needle is inserted through the vaginal wall into a pelvic lesion and a few pieces of tissue are obtained for examination.

This clinical trial is organized to evaluate the safety and efficacy of transvaginal tru-cut biopsy in a large group of patients with tumors in the small pelvis.

Ovarian cancer is known to be the 4th most lethal tumour in women and has the highest mortality rate of all gynaecological malignancies. In most women, the disease is not diagnosed until advanced stage \[1\]. Moreover, the pelvis and ovaries in particular, are also a common place for secondary metastases. In 4% of ovarian masses, metastasis can be found from a tumour with another primary origin \[2\]. In primary ovarian cancer, patients may benefit from either primary debulking surgery or neoadjuvant therapy, depending on tumour staging and patients' comorbidities \[5\]. In recurrent disease treatment may include surgery, radiotherapy or systemic therapy, depending on primary tumour histology, extent of recurrence, previous treatment and disease-free interval \[6-8\]. In pelvic masses with ultrasound features suggesting metastatic disease, management will be guided by the origin of the primary tumour \[9,10\]. Therefore, histological diagnosis is important to select the optimal treatment strategy.

Tissue sampling by diagnostic laparoscopy or explorative laparotomy requires general anaesthesia and hospital admission, leading to higher costs and to potential surgical morbidity. Moreover, diagnostic laparoscopy is associated with a risk of port-site metastasis, ranging from 0.3-0.4% in endometrial and cervical cancer \[11\] and even 17-49% in advanced ovarian cancer \[12,13\].

Minimally invasive procedures for diagnosis include fine-needle aspiration and tru-cut biopsy.

At fine-needle aspiration the quantity and integrity of the tissue is limited, enabling cytological evaluation only \[14\]. Tru-cut biopsy results in a higher specificity compared to fine needle biopsy and it enables histological examination including immunohistochemistry \[15,16\].

A tru-cut biopsy can be performed under the guidance of different imaging modalities including ultrasound, Computed Tomography (CT) and Magnetic Resonance Imaging (MRI). However, percutaneous CT-guided biopsies of deep pelvic masses are challenging because vital structures often obstruct the needle pathway \[17\].

Previous studies have investigated the use of ultrasound-guided biopsies for the assessment of abdominal and pelvic masses which showed a high diagnostic adequacy and minimal complication rate \[4,16,18-25\]. This can be done by percutaneous transabdominal approach , a transvaginal or transrectal approach.

The main goal of this prospective study is to evaluate the safety and tissue yield of ultrasound guided transvaginal or transrectal tru-cut biopsy in patients with pelvic tumors. Secondly, factors affecting the reliability of the biopsy-results will be analyzed, as well as patients' experience and pain. Finally, a comparison of biopsy results and final histological diagnosis will be performed in those patients undergoing surgical management.

5. Study aims Primary Aim The main goal of our study is 1) to evaluate the safety (defined as absence of procedure-related complications) and 2) tissue yield (defined as sufficient amount of tissue for histological analysis) of ultrasound guided transvaginal or transrectal tru-cut biopsy in patients with pelvic masses.

Secondary Aims

* Analyzing factors affecting the safety and tissue yield. (The influence of selected variables such as number of biopsies per target lesion, length of the shot (15 vs 22 mm), thickness of needle (16-18 G), target lesion, target lesion size, histotypes etc. on these outcomes will be assessed.)
* Assessment of patients' overall experience, assessment of pain and discomfort during the procedure and afterwards.
* Comparison of biopsy result with final histological diagnosis: histological type (only in patients finally undergoing surgery)

Study design Prospective multicentric observational study

Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.

Defined as absence of procedure-related complications. Procedure related complications will be graded by Clavien-Dindo classification.

Defined as sufficient amount of tissue for histological analysis. This will be a binary variable based on the pathology report.

The length of the needle shot (15 vs 22 mm).

The target lesion histotype - categorical variable defined by the tumour type.

Assessment of patients' overall experience using VAS-Score.

Assessment of patients' pain and discomfort during the procedure using VAS-Score.

Comparison of biopsy result with final histological diagnosis: histological type (only in patients finally undergoing surgery). Binary variable indicating agreement.

UZ Leuven, Leuven, Belgium

Policlinico Universitario A. Gemelli, IRCSS, Rome, Italy.

First Faculty of Medicine, Charles University, Prague, Czech Republic.

Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset, Stockholm, Sweden.

Universitaire Ziekenhuizen KU Leuven

Antineoplastic Agents

Niraparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

This study will utilize Simon's two-stage design: 16 patients will be enrolled in the first portion of this study. If 4 or more patients are progression-free at 12 weeks, an additional 16 patients will be enrolled for a total of n = 32 patients enrolled.

Each patient will receive niraparib daily in 21-day cycles until disease progression or unacceptable toxicity. Mandatory baseline tumor biopsies will occur during study screening, if feasible.

Evan Rosenbaum, MD

The purpose of this study is to test whether the study drug, niraparib, is effective against unresectable and/or metastatic soft tissue sarcoma with DDR mutations. The researchers will also study whether niraparib is safe and causes few or mild side effects, and whether there are groups of DDR mutations in soft tissue sarcoma cells that respond better to treatment with niraparib.

This will be a single-center, open label, phase II study of niraparib and will utilize Simon's two-stage design.

A Study of Niraparib in People With Soft Tissue Sarcoma Who Have Changes in Their Tumor DNA

Phase II Study of Niraparib in Soft Tissue Sarcoma Patients With Altered DNA Damage Repair

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Defined by RECIST 1.1. PFS is defined as the period from start of study treatment until recurrent or progressive of disease (POD) is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death, or date of last study visit involving assessment of disease status.

GlaxoSmithKline

Memorial Sloan Kettering Cancer Center

Myoma

Surgery includes different types of hysterectomy: vaginal hysterectomy, total abdominal hysterectomy and laparoscopic or Robotic hysterectomy. The type of hysterectomy does not influence histological outcome, as long as the uterus is removed in one part (no power morcellation). Indications for surgery and the type of surgery are according to the departments' protocols. If the patient is deemed to be inoperable due to the extent of the disease, a representive biopsy (e.g. trucut biopsy) will be accepted if sufficiently motivated by the oncology team.

Hysterectomy

Christine De Bruyn, MD

Dirk Timmerman, MD, PhD

Thierry Van den Bosch, MD, PhD

Ben Van Calster, MD, PhD

The main objective is to evaluate the diagnostic accuracy of the MUSA terms and definitions, as defined in the paper by Van den Bosch T, Dueholm M, ea. in 2015, to differentiate between different types of myometrial lesions of more than 1 cm. The primary aim is the diagnostic accuracy of the MUSA terms and definitions and the secondary aim the development of a prediction model.

Primary aim: Diagnostic accuracy of the MUSA terms and definitions

Every patient planned for hysterectomy for myometrial pathology (e.g. benign fibroid, benign adenomyoma or malignant uterine sarcoma) will undergo a systematic preoperative ultrasound scan. Around 50 ultrasound characteristics (described in Addendum 1) will be assess as to diagnostic accuracy as predictors (Prospective evaluation of MUSA terms and definitions). Figure 1 shows the different histological endpoint with expected prevalence in our study population and table 1 further differentiate those histological endpoints. The estimation for sarcomas is based on preliminary and unpublished results from an ongoing prospective study led by prof dr Antonia Testa from the Università Cattolica di Sacro Cuore Largo Agostino Gemelli in Rome showing an incidence of 4.9% for uterine sarcomas amongst women with a myometrial lesion referred to their tertiary center (Antonia Testa, personal communication).

Secondary aim: Development of prediction model

The Secondary aim is to build predictive models to differentiate between benign myometrial lesions (e.g. adenomyosis and fibroid) and malignant myometrial lesion (e.g. uterine sarcoma). Because of the small number of cases with malignant myometrial lesion (expected to be 5% of the study population or around 75 women), we will limit the number of variables to be tested in order to avoid overfitting. Based on current literature, we preselected following characteristics for development of a prediction model:

* Outer contour: regular of irregular
* Echogenicity of uterine lesion: uniform (homogeneous) or non-uniform (mixed)
* Colour score: 1 to 4
* Presence of central necrosis
* Maximal diameter of the lesion (in mm)
* Presence of acoustic shadows

Ultrasound Evaluation of the Myometrium Using the MUSA Terminology Comparison With Histology

Ultrasound Evaluation of the Myometrium Using the MUSA Terminology, Comparison With Histology.

Around 50 ultrasound characteristics will be assess as to diagnostic accuracy as predictors (Prospective evaluation of MUSA terms and definitions).

predictive models to differentiate between benign myometrial lesions (e.g. adenomyosis and fibroid) and malignant myometrial lesion (e.g. uterine sarcoma).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors (BIOPSAR)	NCT04250766	Fibroid Uterus Sarcoma Uterus	Echo-guided ute...	35 Years -	Institut Bergonié
Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors (BIOPSAR)	NCT04250766	Fibroid Uterus Sarcoma Uterus	Echo-guided ute...	35 Years -	Institut Bergonié
Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.	NCT05610501	Pelvic Cancer Ovarian Cancer Cervical Cancer Uterus Cancer Endometrial Can... Ovarian Neoplas... Ovarian Carcino... Sarcoma Uterus Metastatic Canc...	Ultrasound guid...	18 Years -	Universitaire Ziekenhuizen KU Leuven
Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.	NCT05610501	Pelvic Cancer Ovarian Cancer Cervical Cancer Uterus Cancer Endometrial Can... Ovarian Neoplas... Ovarian Carcino... Sarcoma Uterus Metastatic Canc...	Ultrasound guid...	18 Years -	Universitaire Ziekenhuizen KU Leuven
A Study of Niraparib in People With Soft Tissue Sarcoma Who Have Changes in Their Tumor DNA	NCT05515575	Sarcoma,Soft Ti... Sarcoma Uterus	Niraparib	18 Years -	Memorial Sloan Kettering Cancer Center
Ultrasound Evaluation of the Myometrium Using the MUSA Terminology Comparison With Histology	NCT04990076	Myoma;Uterus Sarcoma Uterus	Hysterectomy	18 Years -	Universitaire Ziekenhuizen KU Leuven

Spots Global Cancer Trial Database for sarcoma uterus