The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05212779
Recruitment Status : **RECRUITING NOW**
First Posted : January 28, 2022
Last Update Posted : November 8, 2022
Sponsor:
Information provided by (Responsible Party):
John Nakayama, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
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Brief Summary:
Blood samples and Tumor tissue will be collected at certain timepoints and will be tested.
Epithelial Ovarian Cancer
Diagnostic Test: Signatera testing Diagnostic Test: Altera Testing
Detailed Description:
Blood samples will be tested by Natera to identify residual tumor DNA for genetic changes in the tumor to potentially improve prediction of long term prognosis and guide treatment options.
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Study Type :
Observational
Estimated Enrollment :
45 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Predicting the Risk of Ovarian Cancer Recurrence Using Circulating Tumor DNA to Assess Residual Disease
Actual Study Start Date :
October 7, 2022
Estimated Primary Completion Date :
December 30, 2024
Estimated Study Completion Date :
December 30, 2024
Resource links provided by the National Library of Medicine
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Females with Stage II-IV epithelial ovarian cancer
All patients, as participation requirements in this study, are required to have blood drawn at the completion of their adjuvant treatment. Blood sample should be collected within 6 weeks of receiving the last cycle of adjuvant chemotherapy.
Other optional time points which will be encouraged but not required:
After debulking surgery
Serial draws every 3 months while on maintenance or surveillance.
Diagnostic Test: Signatera testing
26mL blood for the first blood draw and tissue sample. 20mL blood all subsequent draws.
Diagnostic Test: Altera Testing
6ml blood and tissue sample.
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Primary Outcome Measures :
To assess the effect of a negative Signatera MRD test on progression free survival (PFS) compared to Signatera MRD testing positive patients. [ Time Frame: Signatera MRD testing done within 6 weeks of finishing adjuvant therapy ]
The Signatera MRD test measures the amount of circulating tumor DNA(ctDNA). We seek to assess the effect of a negative versus positive test on PFS. PFS will be measured in months from the time of last platinum adjuvant chemotherapy to objective disease progression on imaging according to RECIST 1.1 or death from any cause
Secondary Outcome Measures :
To assess the effect of the amount of residual tumor after surgery as defined by Signatera MRD testing on length of PFS [ Time Frame: Post debulking surgery ]
We seek to assess if the amount of residual tumor detected on Signatera MRD testing correlates with length of PFS. Similarly, does an undetectable ctDNA level versus detectable level (by Signatera MRD testing) have different lengths of PFS. PFS will be measured in months from the time of last platinum adjuvant chemotherapy to objective disease progression on imaging according to RECIST 1.1 or death from any cause.
To assess the effect of negative Signatera MRD testing on the length of overall survival (OS) as compared to Signatera MRD testing positive patients [ Time Frame: Signatera MRD testing done within 6 weeks of finishing adjuvant therapy ]
This outcomes seeks to assess if a negative Signatera MRD test has a significantly different OS compared to patients with a positive Signatera MRD test. OS will be measured in months from the time of last platinum adjuvant chemotherapy to death from any cause.
To assess the effect of negative Signatera MRD testing on the length of PFS in patients treated with PARP inhibitors (PARPi) compared to Signatera MRD testing positive patients. [ Time Frame: Signatera MRD testing done within 6 weeks of finishing adjuvant therapy ]
We seek to assess the effect of a negative Signatera MRD test on PFS in patients that are treated with PARPi compared to patients with a positive Signatera MRD test. PFS will be measured in months from the time of last platinum adjuvant chemotherapy to objective disease progression on imaging according to RECIST 1.1 or death from any cause.
To assess if recurrent ovarian cancer is detectable earlier by a rise in ctDNA (by Signatera MRD testing) compared to a rise in CA-125. [ Time Frame: Patients will be measured by Signatera MRD testing within 6 weeks of completing adjuvant treatment and every 3 months for up to 2 years. CA-125 will be measured every 3 months until progressive disease or death. ]
We seek to assess if Signatera MRD testing will show an increase in ctDNA levels prior to a rise of CA-125 above the normal range.
To assess if recurrent ovarian cancer is detectable earlier by a rise in ctDNA (by Signatera MRD testing) compared to radiographic method (objective disease progression by RECIST 1.1). [ Time Frame: Signatera MRD test within 6 weeks of completing adjuvant treatment and every 3 months for up to 2 years. CT every 3 cycles(1 month cycles) while on maintenance or CT for abnormal CA-125, patient symptom, or clinical exam abnormality on surveillance ]
We seek to assess if Signatera MRD testing will show an increase in ctDNA levels prior to objective disease progression by RECIST 1.1
To assess if recurrent ovarian cancer is detectable earlier by a rise in ctDNA (by Signatera MRD testing) compared to recurrence as assessed by the investigator. [ Time Frame: Patients will be measured by Signatera MRD testing within 6 weeks of completing adjuvant treatment and every 3 months for up to 2 years. Physician assessment wil be as per normal surveillance schedule of the investigator. ]
We seek to assess if Signatera MRD testing will show an increase in ctDNA levels prior to the diagnosis of recurrent disease as assessed by physician evaluation. The physician may use all available clinical information in this determination.
To assess the effect of maintenance therapy (PARPi or bevacizumab) on the rate of negative Signatera MRD testing as compared to patients not given maintenance therapy. [ Time Frame: Signatera MRD test within 6 weeks of completing adjuvant treatment and every 3 months for up to 2 years. ]
We seek to assess if patients will be more likely to achieve a negative Signatera MRD test if they are given maintenance therapy as compared to surveillance.
We seek to determine if patients assessed with whole exome sequencing (Altera) will show different genetic mutational patterns than those who are Signatera MRD testing positive and negative. [ Time Frame: Signatera MRD testing done within 6 weeks of finishing adjuvant therapy. Altera testing will be done on the tumor and blood sample provided at enrollment. ]
We seek to assess if there are differences in genetic mutations (e.g. BRCA, RAD51, BRIP1, p53, MLH1, PMS2, MSH2 and 6 etc.) between patients that are found to be Signatera MRD testing positive or negative.
We seek to determine if patients assessed with whole exome sequencing (Altera) will show different genetic mutational patterns than those who are PARPi and bevacizumab maintenance therapy responders [ Time Frame: Altera testing will be done on the tumor and blood sample provided at enrollment. ]
We seek to assess if there are differences in genetic mutations (e.g. BRCA, RAD51, BRIP1, p53, MLH1, PMS2, MSH2 and 6 etc.) between patients that are found to be PARPi and bevacizumab maintenance responders
We seek to determine if patients assessed with whole exome sequencing (Altera) will show different genetic mutational patterns when compared by debulking status. [ Time Frame: Altera testing will be done on the tumor and blood sample provided at enrollment. ]
We seek to assess if there are differences in genetic mutations (e.g. BRCA, RAD51, BRIP1, p53, MLH1, PMS2, MSH2 and 6 etc.) between patients whose debulking results in no gross residual disease, optimal debulking or suboptimal debulking
Biospecimen Retention: Â Samples With DNAResidual Material for the purpose of validation, quality assurance, and correlation of results, including for regulatory, reimbursement and patent filings, to the extent the foregoing is related or pertains to the results of the research project and the Signatera assay, which is used to perform the research project.
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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Ages Eligible for Study: Â
18 Years to 95 Years  (Adult, Older Adult)
Sexes Eligible for Study: Â
Female
Gender Based Eligibility: Â
Yes
Gender Eligibility Description: Â
Epithelial Ovarian Cancer
Accepts Healthy Volunteers: Â
No
Sampling Method: Â
Non-Probability Sample
Allegheny Health Network Cancer Institute clinics throughout the system
Inclusion Criteria:
Clinical diagnosis of epithelial ovarian cancer stage II-IV
Exclusion Criteria:
Insufficient tumor to perform Signatera testing; Inability to provide consent for the trial
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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): NCT05212779
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AHN West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Contact: John Nakayama, MD Â Â 412-578-1116 ext 2 Â Â Â Â
Contact: Clinical Trials Contact   412-330-6151   clinicaltrials@ahn.org  Â
Sub-Investigator: Ali Amjad, MD Â Â Â Â Â Â
Sub-Investigator: Sarah Crafton, MD Â Â Â Â Â Â
Sub-Investigator: Thomas Krivak, MD Â Â Â Â Â Â
Sub-Investigator: Eirwen Miller, MD Â Â Â Â Â Â
Sub-Investigator: Casey Moffa, DO Â Â Â Â Â Â
Sub-Investigator: Christopher Morse, DO Â Â Â Â Â Â
Principal Investigator: John Nakayama, MD Â Â Â Â Â Â
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
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Principal Investigator:
John Nakayama, MD
Allegheny Health Network
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Responsible Party:
John Nakayama, MD, PI, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
ClinicalTrials.gov Identifier:
NCT05212779 Â Â
Other Study ID Numbers:
Signatera
First Posted:
January 28, 2022 Â Â Key Record Dates
Last Update Posted:
November 8, 2022
Last Verified:
November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No
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Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
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Ovarian NeoplasmsCarcinoma, Ovarian EpithelialRecurrenceEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Neoplasms, Female
Urogenital NeoplasmsEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeDisease AttributesPathologic Processes
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
