Brief Title
DOvEEgene: Diagnosing Ovarian and Endometrial Cancer Early Using Genomics
Official Title
DOvEEgene: Diagnosing Ovarian and Endometrial Cancer Early Using Genomics
Brief Summary
This study aims to develop and validate a test for diagnosing ovarian and endometrial cancers
early. It relies on detecting somatic mutations that are associated with these cancers in a
biofluids sample taken from the cervix and the uterine cavity.
Detailed Description
For women in high-income countries, ovarian/fallopian tube and endometrial cancers are within
the top four cancers in terms of incidence, death and healthcare expenditure. The deaths
associated with these cancers are largely caused by stage III/IV disease, for which cure
rates have not changed in three decades, despite escalating costs of treatment. Attempts at
early diagnosis have been ineffective in reducing mortality, because the high-grade subtypes,
which account for the majority of deaths, metastasize while the primary cancer is still
small, has not caused symptoms, and is undetectable by imaging or blood tumour markers.
In recent years, the recognition that somatic mutations are early steps in carcinogenesis has
led to a shift from tests such as imaging and non-specific blood tumour markers to technology
that detects cancer-associated mutations in cervical, uterine, or blood samples. Several
DNA-tagging technologies have been shown to be capable of identifying small amount of cancer
DNA among thousands of normal cells, the proverbial needle in a haystack.
This investigation aims to develop and validate an in-house developed DNA tagging technology
'DOvEEgene-Haloplex' for the early diagnosis of endometrial and ovarian cancers. The assay
pipeline for barcoding and agnostic testing of the biofluids must lend itself to automation
and high throughput testing. It must have good sensitivity and more importantly very high
specificity, as the only way to corroborate a positive test is to remove the uterus, tubes
and ovaries.
Study Type
Observational
Primary Outcome
Detection of cancer-related mutations
Secondary Outcome
Patient related outcomes including pain and acceptability
Condition
Ovarian Neoplasms
Study Arms / Comparison Groups
Case Group
Description: Participants must have suspected or confirmed upper genital tract cancer (uterine, tubal and ovarian) and must be scheduled to undergo surgery for tumor removal.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
1200
Start Date
January 2014
Completion Date
December 2023
Primary Completion Date
October 2020
Eligibility 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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Dr. Lucy Gilbert, MD,MSc,FRCOG, (514) 934-1934, [email protected]
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT02288676
Organization ID
A08-M79-13B
Responsible Party
Principal Investigator
Study Sponsor
McGill University
Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor
Dr. Lucy Gilbert, MD,MSc,FRCOG, Principal Investigator, Professor, McGill University
Verification Date
February 2020