Exploration of DNA Methylation as a Marker for Early Detection of High Grade Serous Epithelial Ovarian Cancer
NCT ID: NCT03622385
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10 participants
OBSERVATIONAL
2019-02-19
2021-09-28
Brief Summary
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Detailed Description
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The "Discovery" phase of this study will obtain tissue samples in a retrospective manner. The investigators will perform genome-scale DNA Methylation analysis to obtain a panel of candidate methylated DNA biomarkers. Twenty archival primary serous epithelial ovarian cancer and twenty archival normal ovarian and salpingeal tissues will be identified by running a report of diagnosis.
During the "Validation" phase of this study, blood and tissue samples will be obtained in a prospective manner. The patients will be undergoing consultation for undiagnosed pelvic mass and are being scheduled for a diagnostic laparoscopic biopsy. At the time of their consultation, patients will be recruited and consented for this phase of the study.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Patients diagnosed with Serous Epithelial Ovarian Cancer
Discovery Cohort: patients who were diagnosed with serous epithelial ovarian cancer whose tissue specimens were previously collected.
Validation Cohort: patients who are scheduled for a diagnostic laparoscopic biopsy for an undiagnosed pelvic mass that is determined to be cancerous.
DNA Methylation
No intervention will be performed. Blood and tissue samples will be analyzed for biomarkers that may be used to develop a diagnostic panel for early detection and diagnosis of high grade serous epithelial ovarian cancer.
Normal patients
Discovery Cohort: patients who were determined to have normal ovarian tissue specimens that were previously collected.
Validation Cohort: patients who are scheduled for a diagnostic laparoscopic biopsy for an undiagnosed pelvic mass that is determined to not be cancerous.
DNA Methylation
No intervention will be performed. Blood and tissue samples will be analyzed for biomarkers that may be used to develop a diagnostic panel for early detection and diagnosis of high grade serous epithelial ovarian cancer.
Interventions
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DNA Methylation
No intervention will be performed. Blood and tissue samples will be analyzed for biomarkers that may be used to develop a diagnostic panel for early detection and diagnosis of high grade serous epithelial ovarian cancer.
Eligibility Criteria
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Inclusion Criteria
* 18 years of age and older
* Women with an undiagnosed pelvic mass who need to undergo diagnostic laparoscopic surgery
Exclusion Criteria
* Under 18 years of age
* Women who can not give informed consent
18 Years
FEMALE
Yes
Sponsors
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Baylor Research Institute
OTHER
Responsible Party
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Principal Investigators
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Jack Stecher, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor Health Care System
Locations
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Baylor University Medical Center
Dallas, Texas, United States
Countries
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References
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Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012 Oct 4;490(7418):61-70. doi: 10.1038/nature11412. Epub 2012 Sep 23.
Lu KH. Screening for Ovarian Cancer in Asymptomatic Women. JAMA. 2018 Feb 13;319(6):557-558. doi: 10.1001/jama.2017.21894. No abstract available.
Melnikov A, Scholtens D, Godwin A, Levenson V. Differential methylation profile of ovarian cancer in tissues and plasma. J Mol Diagn. 2009 Jan;11(1):60-65. doi: 10.2353/jmoldx.2009.080072. Epub 2008 Dec 12.
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
Warton K, Samimi G. Methylation of cell-free circulating DNA in the diagnosis of cancer. Front Mol Biosci. 2015 Apr 22;2:13. doi: 10.3389/fmolb.2015.00013. eCollection 2015.
Buys SS, Partridge E, Greene MH, Prorok PC, Reding D, Riley TL, Hartge P, Fagerstrom RM, Ragard LR, Chia D, Izmirlian G, Fouad M, Johnson CC, Gohagan JK; PLCO Project Team. Ovarian cancer screening in the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial: findings from the initial screen of a randomized trial. Am J Obstet Gynecol. 2005 Nov;193(5):1630-9. doi: 10.1016/j.ajog.2005.05.005.
Jacobs IJ, Menon U, Ryan A, Gentry-Maharaj A, Burnell M, Kalsi JK, Amso NN, Apostolidou S, Benjamin E, Cruickshank D, Crump DN, Davies SK, Dawnay A, Dobbs S, Fletcher G, Ford J, Godfrey K, Gunu R, Habib M, Hallett R, Herod J, Jenkins H, Karpinskyj C, Leeson S, Lewis SJ, Liston WR, Lopes A, Mould T, Murdoch J, Oram D, Rabideau DJ, Reynolds K, Scott I, Seif MW, Sharma A, Singh N, Taylor J, Warburton F, Widschwendter M, Williamson K, Woolas R, Fallowfield L, McGuire AJ, Campbell S, Parmar M, Skates SJ. Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial. Lancet. 2016 Mar 5;387(10022):945-956. doi: 10.1016/S0140-6736(15)01224-6. Epub 2015 Dec 17.
Liggett TE, Melnikov A, Yi Q, Replogle C, Hu W, Rotmensch J, Kamat A, Sood AK, Levenson V. Distinctive DNA methylation patterns of cell-free plasma DNA in women with malignant ovarian tumors. Gynecol Oncol. 2011 Jan;120(1):113-20. doi: 10.1016/j.ygyno.2010.09.019. Epub 2010 Nov 6.
Survival Rates for Ovarian Cancer by Stage. American Cancer society Website, February 2, 2016. https://www.cancer.org/cancer/ovarian-cancer/detection-diagnosis-staging/survival-rates.html
Other Identifiers
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018-530
Identifier Type: -
Identifier Source: org_study_id
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