Predicting the Risk of Ovarian Cancer Recurrence Using Circulating Tumor DNA to Assess Residual Disease

Epithelial Ovarian Cancer Clinical Trial

Official title:

Predicting the Risk of Ovarian Cancer Recurrence Using Circulating Tumor DNA to Assess Residual Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05212779
• Other study ID #: Signatera
• Status: Active, not recruiting
• Start date: October 7, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Blood samples and Tumor tissue will be collected at certain timepoints and will be tested.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms
• Recurrence

Intervention

Diagnostic Test:
• Signatera testing
26mL blood for the first blood draw and tissue sample. 20mL blood all subsequent draws.
• Altera Testing
6ml blood and tissue sample.

Locations

Country	Name	City	State
United States	AHN West Penn Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Signatera MRD testing done within 6 weeks of finishing adjuvant therapy
Secondary	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.	Post debulking surgery
Secondary	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.	Signatera MRD testing done within 6 weeks of finishing adjuvant therapy
Secondary	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.	Signatera MRD testing done within 6 weeks of finishing adjuvant therapy
Secondary	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.	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.
Secondary	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	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
Secondary	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.	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.
Secondary	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.	Signatera MRD test within 6 weeks of completing adjuvant treatment and every 3 months for up to 2 years.
Secondary	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.	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.
Secondary	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	Altera testing will be done on the tumor and blood sample provided at enrollment.
Secondary	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	Altera testing will be done on the tumor and blood sample provided at enrollment.