The purpose of this study is to determine if there are markers in plasma that can be used to develop a diagnostic panel for early detection and diagnosis of high grade serous epithelial ovarian cancer.
- Study Type: Observational
- Study Design
- Time Perspective: Other
- Study Primary Completion Date: October 2020
This study has two phases: "Discovery" cohort and "Validation" cohort.
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.
- Other: 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.
Arms, Groups and Cohorts
- 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.
- 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.
Clinical Trial Outcome Measures
- Identification of DNA markers using HiSeq Genome Analyzer that can predict Serous Epithelial Ovarian Cancer
- Time Frame: 2 years
- Isolate DNA using QiaAMp DNA mini kits from tissue and plasma samples from subjects with serous epithelial ovarian cancer and normal subjects and then sequence the DNA using HiSeq Genome Analyzer. The investigators will identify the sequence reads using Illumina base-calling software and analyze them using Zymo Research proprietary analysis pipeline to identify differences in genomic expression in normal subjects compared to subjects with Serous Epithelial Ovarian Cancer.
Participating in This Clinical Trial
- 18 years of age and older
- Women with an undiagnosed pelvic mass who need to undergo diagnostic laparoscopic surgery
- Under 18 years of age
- Women who can not give informed consent
Gender Eligibility: Female
The investigators are studying biomarkers for the early detection of ovarian cancer. Patients will need to have had ovaries.
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Baylor Research Institute
- Provider of Information About this Clinical Study
- Overall Official(s)
- Jack Stecher, MD, Principal Investigator, Baylor Health Care System
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Citations Reporting on Results
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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
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