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

NCT05212779 | Unknown

• 1 other identifier: Signatera
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• To assess the effect of the amount of residual tumor after surgery as defined by Signatera MRD testing on length of PFS

  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

  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.

  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.

  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).

  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

Study Arms (1)

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.

Diagnostic Test: Signatera testing; Diagnostic Test: Altera Testing

Interventions

Signatera testing DIAGNOSTIC_TEST

26mL blood for the first blood draw and tissue sample. 20mL blood all subsequent draws.

Females with Stage II-IV epithelial ovarian cancer

Altera Testing DIAGNOSTIC_TEST

6ml blood and tissue sample.

Females with Stage II-IV epithelial ovarian cancer

Eligibility Criteria

• Age: 18 Years - 95 Years
• Gender Eligibility Details: Epithelial Ovarian Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Allegheny Health Network Cancer Institute clinics throughout the system

You may qualify if:

• Clinical diagnosis of epithelial ovarian cancer stage II-IV

You may not qualify if:

• Insufficient tumor to perform Signatera testing; Inability to provide consent for the trial

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead

Study Sites (1)

AHN West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Residual 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.

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• John Nakayama, MD

  Allegheny Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 28, 2022
• Study Start: October 7, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)