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 : May 2, 2024

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborators:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Genome Quebec

Jewish General Hospital

Information provided by (Responsible Party):

Dr. Lucy Gilbert, McGill University

Study Description

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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	1200 participants
Observational Model:	Case-Control
Time Perspective:	Cross-Sectional
Official Title:	DOvEEgene: Diagnosing Ovarian and Endometrial Cancer Early Using Genomics
Actual Study Start Date :	January 2014
Estimated Primary Completion Date :	October 2025
Estimated Study Completion Date :	October 2026

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Ovarian cancer

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Ovarian Epithelial Cancer

U.S. FDA Resources

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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 :

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.

Eligibility Criteria

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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.

Contacts and Locations

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	Active, not recruiting
Montreal, Quebec, Canada, H3T 1E2
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/Research Institute of the McGill University Health Centre

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

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. Epub 2012 Jan 17.

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.

Gilbert L, Revil T, Meunier C, Jardon K, Zeng X, Martins C, Arseneau J, Fu L, North K, Schiavi A, Ehrensperger E, Artho G, Lee T, Morris D, Ragoussis J. The empress of subterfuge: cancer of the fallopian tube presenting with malapropism. Lancet. 2017 Sep 2;390(10098):1003-1004. doi: 10.1016/S0140-6736(17)31586-6. No abstract available.

Wang Y, Li L, Douville C, Cohen JD, Yen TT, Kinde I, Sundfelt K, Kjaer SK, Hruban RH, Shih IM, Wang TL, Kurman RJ, Springer S, Ptak J, Popoli M, Schaefer J, Silliman N, Dobbyn L, Tanner EJ, Angarita A, Lycke M, Jochumsen K, Afsari B, Danilova L, Levine DA, Jardon K, Zeng X, Arseneau J, Fu L, Diaz LA Jr, Karchin R, Tomasetti C, Kinzler KW, Vogelstein B, Fader AN, Gilbert L, Papadopoulos N. Evaluation of liquid from the Papanicolaou test and other liquid biopsies for the detection of endometrial and ovarian cancers. Sci Transl Med. 2018 Mar 21;10(433):eaap8793. doi: 10.1126/scitranslmed.aap8793.

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Responsible Party:	Dr. Lucy Gilbert, Professor, Department of Obstetrics and Gynecology & Department of Oncology, McGill University
ClinicalTrials.gov Identifier:	NCT02288676
Other Study ID Numbers:	A08-M79-13B
First Posted:	November 11, 2014 Key Record Dates
Last Update Posted:	May 2, 2024
Last Verified:	May 2024

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 Endometrial Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases	Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases Endocrine System Diseases Gonadal Disorders Uterine Neoplasms Uterine Diseases

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