Dr. Lucy Gilbert, MD, MSc, FRCOG
Ioannis Ragoussis, PhD
McGill University Health Center (MUHC)
Johns Hopkins University
Centre Hospitalier de l'Université de Montréal (CHUM)
Jewish General Hospital
The vast majority of deaths from ovarian cancer are from the high-grade serous cancer (HGSC) subtypes. The current available tests for ovarian cancer diagnosis, such as blood tumour marker CA-125 and transvaginal ultrasound scan of the ovaries, have poor sensitivity and specificity, and are therefore not suitable for diagnosing early disease. Indeed, results from screening trials suggest that testing women in the general population for ovarian cancer may do more harm than good, due to the high proportion of false positive results.
Accumulating evidence suggests that a high proportion of HGSC of the "ovary" actually starts in the fallopian tube. The cancerous cells from the tube can escape into the uterus and eventually into the cervix. Furthermore, the cancer present as a microscopic lesion in the tube is capable of spreading to the ovary and abdomen.
As for endometrial cancer, the disease is increasing in incidence. Approximately 10% of women with endometrial cancers with high-grade subtypes account for almost half the deaths of patients with an endometrial cancer diagnosis as a result of early spread.
Combined, cancers from the uterus, tubes and ovaries account for the 3rd most common cause of death from cancer in North American women.
Given the information above, a screening tool for cancers of the uterus, tubes and ovaries would greatly benefit women. Seminal work has shown it is possible to identify a few cancer cells among the thousands of normal cells, in cytology samples. More specifically, those collected from the uterus, cervix and vagina by a variety of sampling techniques using innovative methods of DNA tagging.
We have developed our own technology for DNA barcoding. Additionally, we have also evaluated different methods of sample collection to determine which is the most acceptable to women and their doctors, while still yielding the highest number of abnormal cells.
Our preliminary results indicate a brush sample taken from inside the uterus yields the best proportion of cancer cells with respect to both ovarian/tubal cancers, as well as, uterine cancer.
The objective of this project is to develop, by building on this discovery, a test that can be used as a screening tool to detect cancer of the endometrium, ovary and tubes, in its very early stages.
We are enrolling women with known or suspected cancer of the ovary or endometrium, as well as women scheduled to undergo hysterectomy and salpingectomy +/- oophorectomy for a variety of benign reasons to serve as controls.
We will develop, refine the technology and validate a screening test, DOvEEgene, that is specific and safe to screen women in order to diagnose cancer of the uterus, tubes and ovaries early enough to save lives.
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
The participating hospitals run multiple weekly routine gynecology and gynecologic oncology clinics. The Cases include women scheduled to undergo surgery for tumor removal, for either proven or suspected upper genital tract cancer. The Controls include women scheduled to have a hysterectomy, bilateral salpingectomy (removal of the fallopian tubes) with/without bilateral oophorectomy (removal of the ovaries) to treat benign conditions.
Subjects should have suspected or confirmed cancer of the upper genital tract
Participant will undergo surgery for tumour removal
Subjects should be scheduled to have a hysterectomy, bilateral salpingectomy, with or without bilateral oophorectomy, for presumed benign disease
- Detection of cancer-related mutations
- Determine which of the sampling methods most correctly identifies the presence/absence of cancer-related mutations
Estimated Enrollment: 280
Study Start Date: January 2014
Estimated Study Completion Date : December 2020
Estimated Primary Completion Date: December 2019
Please refer to Figure 1, displayed below, to get a visual grasp of the overall concept of DOvEEgene:
Disclaimer: The information above comes directly from the following source: Clinical Trials (U.S. National Institutes of Health) , Identifier No.: NCT02288676