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Brief Title: DOvEEgene: Diagnosing Ovarian and Endometrial Cancer Early Using Genomics
Official Title: DOvEEgene: Diagnosing Ovarian and Endometrial Cancer Early Using Genomics
Study ID: NCT02288676
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Jewish General Hospital, Montreal, Quebec, Canada
Royal Victoria Hospital (Glen Site), Montreal, Quebec, Canada
Name: Dr. Lucy Gilbert, MD,MSc,FRCOG
Affiliation: Professor, McGill University
Role: PRINCIPAL_INVESTIGATOR
Name: Dr Ioannis Ragoussis, PhD
Affiliation: Genome Quebec
Role: STUDY_DIRECTOR