Epithelial Ovarian CancerNCT05212779
Predicting the Risk of Ovarian Cancer Recurrence Using Circulating Tumor DNA to Assess Residual Disease
An observational study of Epithelial Ovarian Cancer, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial summary
Blood samples and Tumor tissue will be collected at certain timepoints and will be tested. Read more about this study
- Who is it for?
- Ages 18 to 95 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- Signatera testing and Altera Testing
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2022to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Allegheny Health Network Cancer Institute clinics throughout the system
Who may be able to join
- Clinical diagnosis of epithelial ovarian cancer stage II-IV
Who cannot join
- Insufficient tumor to perform Signatera testing; Inability to provide consent for the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
AHN West Penn Hospital
Pittsburgh, Pennsylvania, 15224
About this study
Blood samples and Tumor tissue will be collected at certain timepoints and will be tested.
Read the 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.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Signatera testing, Altera Testing
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signatera testingDiagnostic test
26mL blood for the first blood draw and tissue sample. 20mL blood all subsequent draws.
Altera TestingDiagnostic test
6ml blood and tissue sample.
| Study group | Role | What they receive |
|---|---|---|
| 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:
1. After debulking surgery
2. Serial draws every 3 months while on maintenance or surveillance. Receives: Diagnostic Test: Signatera testing; Diagnostic Test: Altera Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of a negative Signatera MRD test on progression free survival (PFS) compared to Signatera MRD testing positive patients.
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
Measured: Signatera MRD testing done within 6 weeks of finishing adjuvant therapy
Secondary outcomes (10)
To assess the effect of the amount of residual tumor after surgery as defined by Signatera MRD testing on length of PFS
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.
Measured: Post debulking surgery
To assess the effect of negative Signatera MRD testing on the length of overall survival (OS) as compared to Signatera MRD testing positive patients
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.
Measured: Signatera MRD testing done within 6 weeks of finishing adjuvant therapy
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.
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.
Measured: Signatera MRD testing done within 6 weeks of finishing adjuvant therapy
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.
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.
Measured: 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.
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).
We seek to assess if Signatera MRD testing will show an increase in ctDNA levels prior to objective disease progression by RECIST 1.1
Measured: 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
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.
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.
Measured: 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.
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.
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.
Measured: Signatera MRD test within 6 weeks of completing adjuvant treatment and every 3 months for up to 2 years.
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.
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.
Measured: 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 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
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
Measured: Altera testing will be done on the tumor and blood sample provided at enrollment.
We seek to determine if patients assessed with whole exome sequencing (Altera) will show different genetic mutational patterns when compared by debulking status.
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
Measured: Altera testing will be done on the tumor and blood sample provided at enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start7 Oct 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Nakayama, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- John Nakayama, MD, Principal investigator, Allegheny Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212779
- Sponsor's protocol ID
- Signatera
- Status last verified
- Jan 2024
- First submitted
- 30 Dec 2021
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting the Risk of Ovarian Cancer Recurrence Using Circulating Tumor DNA to Assess Residual Disease
- ClinicalTrials.gov ID
- NCT05212779
- Acronym / sponsor ID
- Signatera
- Conditions
- Epithelial Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Blood samples and Tumor tissue will be collected at certain timepoints and will be tested.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Females with Stage II-IV epithelial ovarian cancer | – | Diagnostic Test: Signatera testing, Diagnostic Test: Altera TestingAll 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: 1. After debulking surgery 2. Serial draws every 3 months while on maintenance or surveillance. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Allegheny Health Network Cancer Institute clinics throughout the system
Key inclusion criteria (1 listed)
- Clinical diagnosis of epithelial ovarian cancer stage II-IV
Key exclusion criteria (1 listed)
- Insufficient tumor to perform Signatera testing; Inability to provide consent for the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Signatera testing26mL blood for the first blood draw and tissue sample. 20mL blood all subsequent draws. | Diagnostic test | Females with Stage II-IV epithelial ovarian cancer |
| Altera Testing6ml blood and tissue sample. | Diagnostic test | Females with Stage II-IV epithelial ovarian cancer |
Primary outcome
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
10 secondary outcomes
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
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
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
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.
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
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.
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 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 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 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Nakayama, MD principal investigator
Allegheny Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epithelial Ovarian Cancer, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.