Clinical trial NCT05212779: Predicting the Risk of Ovarian Cancer Recurrence Using Circulating Tumor DNA to Assess Residual Disease
Official title: Predicting the Risk of Ovarian Cancer Recurrence Using Circulating Tumor DNA to Assess Residual Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Epithelial Ovarian Cancer
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Allegheny Health Network Cancer Institute clinics throughout the system

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess the effect of a negative Signatera MRD test on progression free survival (PFS) compared to Signatera MRD testing positive patients.
timeFrame: Signatera MRD testing done within 6 weeks of finishing adjuvant therapy
Secondary outcomes:
measure: To assess the effect of the amount of residual tumor after surgery as defined by Signatera MRD testing on length of PFS
timeFrame: Post debulking surgery
measure: To assess the effect of negative Signatera MRD testing on the length of overall survival (OS) as compared to Signatera MRD testing positive patients
timeFrame: Signatera MRD testing done within 6 weeks of finishing adjuvant therapy
measure: 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.
timeFrame: Signatera MRD testing done within 6 weeks of finishing adjuvant therapy
measure: 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.
timeFrame: 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.
measure: 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).
timeFrame: 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
measure: 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.
timeFrame: 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.
measure: 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.
timeFrame: Signatera MRD test within 6 weeks of completing adjuvant treatment and every 3 months for up to 2 years.
measure: 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.
timeFrame: 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.
measure: 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
timeFrame: Altera testing will be done on the tumor and blood sample provided at enrollment.
measure: We seek to determine if patients assessed with whole exome sequencing (Altera) will show different genetic mutational patterns when compared by debulking status.
timeFrame: Altera testing will be done on the tumor and blood sample provided at enrollment.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: AHN West Penn Hospital
state: Pennsylvania
Study officials:
affiliation: Allegheny Health Network
name: John Nakayama, MD
role: PRINCIPAL_INVESTIGATOR
References: