DOvEEgene/WISE Genomics: Diagnosing Ovarian and Endometrial Cancer Early Using Genomics

NCT02288676 | Recruiting

• 1 other identifier: A08-M79-13B
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop and validate a test for detecting ovarian and endometrial cancers early. It relies on detecting somatic mutations that are associated with these cancers from a uterine pap test. A saliva sample is also collected that acts as an internal control and has the ability to detect deleterious germline mutations associated with common hereditary cancers (such as breast, ovarian, endometrial, colon, and pancreatic cancers). A machine learning classifier is then used to discriminate between cancer and benign disease.

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Endometrial Cancer; Ovarian Cancer; Screening; Safety; Reduced Mortality; Reduced Morbidity; Early Diagnosis

Keywords

genomics; somatic mutations; genetic mutations; high-grade serous cancer; ovarian cancer; endometrial cancer; DNA tagging

Outcome Measures

Primary Outcomes (1)

• Detection of cancer-related mutations

  Diagnosis ovarian and endometrial cancers by detection of cancer-related mutation taken by brush sample of uterus with high sensitivity and specificity.

  3 years

Secondary Outcomes (2)

• Patient related outcomes including pain and acceptability

  3 years

• Risks associated with the DOvEEgene test

  3 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subjects should have suspected or confirmed cancer of the upper genital tract.
• Participant will undergo surgery for tumour removal.
• Subjects should be scheduled to have a hysterectomy, bilateral salpingectomy, with or without bilateral oophorectomy, for presumed benign disease.

Sponsors & Collaborators

• McGill University: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (1)

Royal Victoria Hospital (Glen Site)

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Related Publications (4)

• 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.

  PMID: 22257524 BACKGROUND

• 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.

  PMID: 23303603 BACKGROUND

• 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.

  PMID: 28872014 BACKGROUND

• 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.

  PMID: 29563323 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Disease

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; 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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Ioannis Ragoussis, PhD

  McGill Genome Center

  STUDY DIRECTOR

Central Study Contacts

Dr. Lucy Gilbert, MD,MSc,FRCOG

CONTACT

(514) 934-1934; lucy.gilbert@mcgill.ca

Dr. Claudia Martins, PhD

CONTACT

(514) 934-1934; claudia.martins@mcgill.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Obstetrics and Gynecology & Department of Oncology

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: November 11, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)