Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Ovarian Cancer

Ovarian Epithelial Cancer

Participants must have suspected or confirmed upper genital tract cancer (uterine, tubal and ovarian) and must be scheduled to undergo surgery for tumor removal.

Patients will undergo uterine sampling with DOvEEgene Fleur endometrial sampling device prior to surgical intervention, in addition to standard of care treatment.

DOvEEgene Fleur Sampling

Dr. Lucy Gilbert, MD,MSc,FRCOG

Dr. Claudia Martins, PhD

This study is related to a previous study from the same group which started in 2014 (NTC02288676, McGill REB A08-M79-13B, MUHC REB 2020-5945) to develop a clinically implementable screening test -DovEEgene: developing and validating a novel molecular test for the early diagnosis of cancer of the endometrium, tubes and ovaries. This study is designed to identify endometrial, tubal and ovarian cancer very early based on identifying cancer-specific mutations (cancer DNA) in a pap sample taken from inside the uterus. The results are particularly encouraging given that control group is challenging with high background mutational burden from benign tumours, endometriosis, germ-line mutations etc.

To date, all the intrauterine samples were obtained using the commercially available TAO brush™ which is designed to take an endometrial sample. However, when patient tolerability was assessed using a numerical pain scale (NPS) ranging from 0 (no pain) to 10 (severe pain), patients rated the sampling using the TAO brush™ at 3.5 versus 0 for a cervical pap sample. These results were not surprising as the TAO brush™ was designed for dislodging strips of endometrial tissue to use for histopathologic examination. With respect to the investigators objective, which is to collect cancer cells that have exfoliated to the uterus, a sampler that collects these exfoliated cells with as little disturbance as possible to the underlying endometrium is preferred. In this sub-study, the investigators aim to evaluate a new endometrial sampling tool, the DOvEEgene Fleur, which is believe to be superior to the current TAO brush™ in terms of cancer detection, ease of use and patient tolerability. The sampler has been designed using materials/components found in the TAO brush™ and other approved medical devices.

DOvEEgene Fleur: New Uterine Sampling Tool

Evaluate pain tolerability and acceptability during and after endometrial sample collection. This will be assessed using pain scores reported by participants on numeric pain scale (NPS) ranging from 0 to 10. Final pain scores with the DOvEEgene Fleur will be compared to historical pain scores collected with the TAO brush (Cook Medical).

Ease of use of the DOvEEgene Fleur will be evaluated through a physician feedback form.

Molecular assessment to verify DOvEEgene Fleur is capable of detecting cancer cells from the uterus.

McGill University Health Centre/Research Institute of the McGill University Health Centre

GSE Biomedical

McGill University

Professor Department of Obstetrics & Gynecology and Department of Oncology

Symptoms and General Pathology

Syndrome

Endometrial Neoplasms

Polycystic Ovary Syndrome

Uterine Neoplasms

Menorrhagia

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Endocrine System Diseases

Hemorrhage

Uterine Hemorrhage

Uterine Diseases

Menstruation Disturbances

Genital Neoplasms, Female

Urogenital Neoplasms

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.

Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

Cook Group Incorporated

patients with risk of endometrial cancer in the postmenopausal period

Qiling Li, MD, PHD

Investigators aim to collect endometrial sampling with Li Brush among target population who have risks for endometrial neoplasm, then Fractional curettage should performed with these participants, investigators intend to compare the pathological diagnosis results of cytology and fractional curettage to evaluate the sensitivity of Li Brush and investigators expect that the brush can be used for screening of endometrial cancer in the postmenopausal period in the clinic.

Investigators screen the suitable participants according to the inclusion and exclusion standards, and then collect their endometrial sampling with Li Brush. Pathologists will help to decide the cytology obtained by Li Brush and histology diagnosis of the endometrial sampling. Comparing the pathological diagnosis results of cytology and histology, investigators want to prove the feasibility of cytology diagnosis of endometrial cancer in the postmenopausal period, as the same time, investigators intend to evaluate the possible factors that affecting the precision of Li Brush for endometrial cancer in the postmenopausal period.

The Feasibility Study of the Li Brush for the Screening of Endometrial Cancer in the Postmenopausal Period

The Feasibility Study of Li Brush for the Screening of Endometrial Cancer in the Postmenopausal Period

Kappa statistic will be used to access the agreement of the two diagnosis results. The diagnosis result is dichotomous data: having endometrial cancer or not. The safety risk is the same as it of the gold standard.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
DOvEEgene Fleur: New Uterine Sampling Tool	NCT04258449	Women With Susp...	DOvEEgene Fleur...	18 Years -	McGill University
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
DOvEEgene Fleur: New Uterine Sampling Tool	NCT04258449	Women With Susp...	DOvEEgene Fleur...	18 Years -	McGill University
The Feasibility Study of the Li Brush for the Screening of Endometrial Cancer in the Postmenopausal Period	NCT02512848	Endometrial Neo...		40 Years - 80 Years	First Affiliated Hospital Xi'an Jiaotong University

Spots Global Cancer Trial Database for endometrial sampling