DNA-seq of human peripheral blood plasma samples (circulating-tumor DNA) with suspicious ovarian mass with a CA-125 level of > 35 U/mL
Ovarian cancer is a difficult-to-treat malignancy with a high recurrence rate of 70–80% in the late stage and 20–25% in the early stage. Primary debulking surgery (PDS) or interval debulking surgery (IDS), followed by platinum-based adjuvant chemotherapy, is the standard of care for ovarian cancer. Patients with ovarian cancer who underwent PDS or IDS for a newly diagnosed disease, diagnostic laparoscopy, or secondary debulking for a recurrent disease at the Yonsei Cancer Center, Seoul, Republic of Korea, were prospectively recruited between October 2019 and March 2022 (NCT 05504174). For the non-cancer control group, patients who underwent surgery for a suspicious ovarian mass with a CA-125 level of > 35 U/mL were enrolled. Patients with ovarian cancer received adjuvant therapy based on the current standard of care as clinicians were blinded to the ctDNA results.  We aimed to assess the clinical utility of ctDNA testing using tumor-naïve, small-sized next-generation sequencing (NGS) panels. A total of 296 patients, including 201 with ovarian cancer and 95 with benign or borderline disease, were enrolled. Patients received adjuvant therapy based on the current standard of care. Cell-free DNA was extracted and sequenced using an NGS panel of nine genes: TP53, BRCA1, BRCA2, ARID1A, CCNE1, KRAS, MYC, PIK3CA, and PTEN.