An observational study to assess clinical and patient-reported treatment outcomes in ovarian cancer

Ovarian cancer (ovarian carcinoma) is a malignant cancer that is usually not detected until it has reached an advanced stage, as the symptoms are nonspecific. The SCOUT-1 study focuses on the so-called “high-grade epithelial” form of ovarian cancer at an advanced stage (FIGO III or IV), which can also affect the fallopian tubes or the peritoneum. The risk of developing ovarian cancer is increased in the presence of certain genetic mutations. In some women, there is a clustering of breast and ovarian cancers, as well as other types of cancer, within the family; this is known as hereditary breast and ovarian cancer syndrome (HBOC). In about a quarter of these cases, a genetic mutation is present, most commonly in the BRCA1 and BRCA2 genes. These genetic mutations can be targeted with specific treatments. Standard treatment for ovarian cancer typically begins with surgery and platinum-based chemotherapy. This is usually followed by what is known as adjuvant therapy, which is intended to delay or prevent the recurrence of the disease—for example, with bevacizumab, a drug that helps slow tumor growth by disrupting the tumor’s blood supply. PARP inhibitors (poly-ADP-ribose polymerase inhibitors) represent another treatment option. They are particularly effective against tumors with a BRCA mutation, as they specifically exploit the cancer cells’ inability to repair DNA—which is caused by the genetic mutation—and can thus effectively halt their growth.

The goal of the SCOUT-1 study is to determine the effects of various initial treatments—particularly maintenance therapy with PARP inhibitors—in routine clinical practice for patients with advanced ovarian cancer. Among other things, the study systematically records the response to therapy, disease progression (progression-free survival, PFS), patients’ quality of life, the use of genetic tests (e.g., BRCA), and the experiences of the treating physicians. This is therefore what is known as an observational study. This means that patients receive their treatment as usual from their treating physicians, and the study documents routinely collected data on disease progression and treatment. The maintenance therapy used is therefore tailored individually to each patient in consultation with her physician and consists of either PARP inhibitor or bevacizumab maintenance therapy. A group of patients who do not receive maintenance therapy serves as the control group. Patients will be followed for up to seven years. During routine medical visits, data on medical history and current treatment will be collected. Participation in the study will not result in any additional follow-up appointments. The goal is to gain a more comprehensive picture of everyday treatment practices and the benefits of various therapeutic approaches.

Eligible participants are adult women aged 18 and older who have recently been diagnosed with advanced, high-grade epithelial ovarian cancer. A prerequisite is that they are eligible for platinum-based chemotherapy or have already completed no more than three cycles of platinum-based chemotherapy without any progression of the disease to date. Genetic testing for BRCA or HRD status must have already been performed or be scheduled. Women who are currently participating in another clinical trial for initial treatment or who have another type of cancer are excluded from participation. Pregnancy or breastfeeding also preclude participation.