DOvEEgene: Diagnosing Ovarian and Endometrial Cancer Early Using Genomics (DOvEEgene)
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|ClinicalTrials.gov Identifier: NCT02288676|
Recruitment Status : Recruiting
First Posted : November 11, 2014
Last Update Posted : September 11, 2018
|Condition or disease|
|Ovarian Neoplasms Endometrial Neoplasms Endometrial Cancer Ovarian Cancer Screening Safety Reduced Mortality Reduced Morbidity Early Diagnosis|
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|
|Estimated Enrollment :||280 participants|
|Official Title:||DOvEEgene: Diagnosing Ovarian and Endometrial Cancer Early Using Genomics|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||December 2023|
Participants must have suspected or confirmed upper genital tract cancer (uterine, tubal and ovarian) and must be scheduled to undergo surgery for tumor removal.
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.
- Detection of cancer-related mutations [ Time Frame: 3 years ]Diagnosis ovarian and endometrial cancers by detection of cancer-related mutation taken by brush sample of uterus with high sensitivity and specificity.
- Patient related outcomes including pain and acceptability [ Time Frame: 3 years ]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.
- Risks associated with the DOvEEgene test [ Time Frame: 3 years ]Evaluate all risks associated with the DOvEEgene test including complications from the sampling technique as well as unnecessarily interventions resulting from false positive tests.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02288676
|Contact: Dr. Lucy Gilbert, MD,MSc,FRCOG||(514) 934-1934 ext email@example.com|
|Contact: Dr. Claudia Martins, PhD||(514) 934-1934 ext firstname.lastname@example.org|
|Jewish General Hospital||Recruiting|
|Montreal, Quebec, Canada, H3T 1E2|
|Contact: Shannon Salvador, MD 514 3408222 ext 3144 email@example.com|
|Royal Victoria Hospital (Glen Site)||Recruiting|
|Montreal, Quebec, Canada, H4A 3J1|
|Contact: Dr. Lucy Gilbert, MD,MSc,FRCOG (514)934-1934 ext 34049 firstname.lastname@example.org|
|Contact: Dr. Claudia Martins, PhD (514)934-1934 ext 36794 email@example.com|
|Principal Investigator:||Dr. Lucy Gilbert, MD,MSc,FRCOG||Professor, McGill University|
|Study Director:||Dr Ioannis Ragoussis, PhD||Genome Quebec|