Women's Health - DOvEEgene banner

Women's Health - DOvEEgene

DOvEEgene: Developing and Validating a Novel Molecular Screening Test for the Early Diagnosis of Cancer of the Endometrium, Tubes and Ovaries (DOvEEgene)
 
This study is currently recruiting participants. 
 
Sponsor:
McGill University
 
Collaborators:
McGill University Health Centre
McGill University Genome Quebec Innovation Centre
Johns Hopkins University
Jewish General Hospital
 
ClinicalTrials.gov Identifier: NCT02288676
Other Study ID Numbers: A08-M79-13B
 
Purpose
This study will determine whether a genetic test of Pap samples taken from the uterus is capable of detecting ovarian and endometrial cancers.
 
Condition

Ovarian Neoplasms
Endometrial Neoplasms
Endometrial Cancer
Ovarian Cancer
Screening
Safety
Reduced Mortality
Reduced Morbidity
Early Diagnosis


Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: DOvEEgene: Developing and Validating a Novel Molecular Screening Test for the Early Diagnosis of Cancer of the Endometrium, Tubes and Ovaries
 
Primary Outcome Measures:
Detection of cancer-related mutations: Diagnosis of ovarian and endometrial cancers by detection of cancer-related mutations in uterine pap samples using genomics and machine learning to insure high sensitivity and specificity of the test.
 
Secondary Outcome Measures:
 Evaluation of patient related outcomes including pain and acceptability: Pain scores reported by participants on numeric pain and discomfort scale (NPS). Patients’ attitude towards the test including willingness to have it done on an annual basis will be evaluated.
 
 Evaluation of risks associated with the DOvEEgene test: Evaluate all risks associated with the DOvEEgene test including complications from sampling techniqus as well as unnecessary interventions from results of a false positive test.
 
 Assess feasibility of performing endometrial sample by clinicians: The ease of performing the endometrial sampling will be evaluated by clinician feedback in order to assess, and modify if needed.
 
Estimated Enrollment: 1200
Study Start Date: January 2014
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
 
Groups/Cohorts
Cancer Case Group
Participants must have suspected or confirmed upper genital tract cancer (uterine, tubal and ovarian) and must be scheduled to undergo surgery for tumor removal.
Control Group
Participants must not be under investigation for any pre-cancerous or cancerous lesions of the genital tract, and must be scheduled for a hysterectomy, bilateral salpingectomy with/without bilateral oopherectomy for presumed benign condition.
 
 
Detailed Description:
The vast majority of deaths from ovarian cancer are from the high-grade serous cancer (HGSC) subtypes. The currently 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 therefore are 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 high resource countries.

Thus, 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, with an endometrial sampling tool 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.
 
Eligibility
 
Ages Eligible for Study: 18 Years and older   (Adult, Senior)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
 
Study Population
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.
 
Criteria
Case Inclusion:
Subjects should have suspected or confirmed cancer of the upper genital tract.
Participant will undergo surgery for tumour removal.
Control inclusion:
• Subjects should be scheduled to have a hysterectomy, bilateral salpingectomy, with or without bilateral oophorectomy, for presumed benign disease.

Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. 
 
Contacts
 
Contact: Dr. Lucy Gilbert, MD, MSc, FRCOG 514-934-1934 ext. 34049, lucy.gilbert@mcgill.ca
 
Contact: Dr. Claudia Martins, PhD, 514-934-1934 ext. 36794, claudia.martins@mcgill.ca
 
Locations
 
Canada, Quebec

Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Shannon Salvador, MD, 514-340-8222 ext. 3144, shannon.salvador@mcgill.ca
 
Royal Victoria Hospital (Glen Site) Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Dr. Lucy Gilbert, MD,MSc,FRCOG, 514-934-1934 ext. 34049, lucy.gilbert@mcgill.ca
 
Contact: Dr. Claudia Martins, PhD, 514-934-1934 ext. 36794, claudia.martins@mcgill.ca
 
Sponsors and Collaborators:
McGill University
McGill University Health Centre
McGill University Genome Quebec Innovation Centre
Johns Hopkins University
Jewish General Hospital

Investigators
 
Principal Investigator: Dr. Lucy Gilbert, MD,MSc,FRCOG Professor, McGill University
Co-Investigator: Ioannis Ragoussis, PhD, McGill University Genome Quebec Innovation Centre
 
More Information
 
Publications:
Gilbert L, Basso O, Sampalis J, Karp I, Martins C, Feng J, Piedimonte S, Quintal L, Ramanakumar AV, Takefman J, Grigorie MS, Artho G, Krishnamurthy S; DOvE Study Group.. Assessment of symptomatic women for early diagnosis of ovarian cancer: results from the prospective DOvE pilot project. Lancet Oncol. 2012 Mar;13(3):285-91. doi: 10.1016/S1470-2045(11)70333-3.
Kinde I, Bettegowda C, Wang Y, Wu J, Agrawal N, Shih IeM, Kurman R, Dao F, Levine DA, Giuntoli R, Roden R, Eshleman JR, Carvalho JP, Marie SK, Papadopoulos N, Kinzler KW, Vogelstein B, Diaz LA Jr. Evaluation of DNA from the Papanicolaou test to detect ovarian and endometrial cancers. Sci Transl Med. 2013 Jan 9;5(167):167ra4. doi: 10.1126/scitranslmed.3004952.