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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
Sponsor:
Collaborators:
McGill University Health Center
Genome Quebec
Jewish General Hospital
Information provided by (Responsible Party):
Dr. Lucy Gilbert, McGill University

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.

Condition or disease
Ovarian Neoplasms Endometrial Neoplasms Endometrial Cancer Ovarian Cancer Screening Safety Reduced Mortality Reduced Morbidity Early Diagnosis

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.


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Study Type : Observational
Estimated Enrollment : 280 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.


Information from the National Library of Medicine

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


Contacts
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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 35249 claudia.martins@mcgill.ca

Locations
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Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Shannon Salvador, MD    514 3408222 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 Center
Genome Quebec
Jewish General Hospital
Investigators
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Principal Investigator: Dr. Lucy Gilbert, MD,MSc,FRCOG Professor, McGill University
Study Director: Dr Ioannis Ragoussis, PhD Genome Quebec

Publications:

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Responsible Party: Dr. Lucy Gilbert, Professor, Department of Obstetrics and Gynecology & Department of Oncology, McGill University
ClinicalTrials.gov Identifier: NCT02288676     History of Changes
Other Study ID Numbers: A08-M79-13B
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

Keywords provided by Dr. Lucy Gilbert, McGill University:
genomics
somatic mutations
genetic mutations
high-grade serous cancer
ovarian cancer
endometrial cancer
DNA tagging

Additional relevant MeSH terms:
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Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endometrial Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Uterine Diseases