CAROLIN - A non-interventional observational study to assess disease, patient, and treatment characteristics in long-term survivors of ovarian cancer

Ovarian cancer (ovarian carcinoma) is a malignant disease of the ovaries that, in most cases, arises from the uncontrolled proliferation of the surface (epithelial) cells of the ovaries. It may present with symptoms such as abdominal pain or bloating, but is usually not detected until it has reached an advanced stage. Recurrent ovarian carcinoma means that the cancer has returned after treatment.

The standard treatment for ovarian cancer involves surgical removal of the tumor. This is followed by chemotherapy with platinum-based drugs to combat any remaining cancer cells. If this treatment prevents the cancer from returning for at least six months, the tumor is classified as platinum-sensitive. In this case, if the disease progresses again (recurrence), it is recommended to repeat platinum-based chemotherapy. This is then often combined with other drugs to improve the treatment’s effectiveness. This is followed by maintenance therapy to delay the recurrence of tumor growth and prolong survival. This therapy helps keep the disease under control in the long term but cannot completely cure the cancer. Various drugs are options for maintenance therapy. One class of drugs is PARP inhibitors, which include niraparib. They are particularly effective in cases of mutations in the BRCA gene. However, niraparib is also effective and approved for patients who do not have a BRCA gene mutation.

The goal of the CAROLIN study is to collect long-term data on niraparib, a drug already approved for this indication. The aim is to investigate factors related to the disease, the patients, and the treatment that may be associated with long-term survival. The study is purely observational. During treatment with niraparib, data will be collected every 3 months, and every 6 months after treatment ends, as part of routine examinations (e.g., via questionnaires). The observation period will last for up to 7 years. The decision to treat with niraparib is not made within the framework of the study but should be made independently of the study, in accordance with clinical guidelines and the specific factors of each patient.

Women aged 18 and older who have platinum-sensitive, recurrent ovarian cancer (ovarian carcinoma) and are eligible for niraparib treatment may participate in the study. Enrollment in the study is possible up to 3 months after the start of niraparib therapy.