The HELP-ER study was designed to improve the treatment of patients with a first relapse of platinum-sensitive ovarian cancer. In the first phase (Part A), patient data from a database is analyzed in order to develop an algorithm that predicts the outcome of surgery using biomarkers. In the second phase (Part B), this algorithm will be tested in a new group of patients. The aim is to make the treatment more targeted and successful. The study is purely observational, with no intervention in the treatment.

What is being investigated in this study?

The idea for this study is based on the fact that there is no clear standard for the treatment of relapse in ovarian cancer. Relapses are often treated with either chemotherapy or surgery. New studies show that complete removal of the tumor in case of recurrence can prolong survival. During these studies, the AGO score was also developed and validated. This score is used to predict the surgical removability of the tumor. However, not all patients benefit equally from surgery, which is why it makes sense to expand the score to include other influencing factors.

HE4 (Human Epididymis Protein 4) is a protein that can be measured in the blood. It is often highly expressed in ovarian cancer and could help to better plan treatment. The study is therefore investigating whether certain biomarkers such as HE4 can help predict who might benefit from surgery.

What is the aim of the study?

The aim of the HELP-ER study is to improve the AGO score by including additional biomarkers such as HE4 and CA125 in the assessment. The AGO score is a tool that helps doctors to assess whether complete tumor removal by surgery is likely in the event of a recurrence of ovarian cancer.

The addition of biomarkers could increase predictive accuracy, as they provide additional information on tumor status and disease activity. The aim is to avoid unnecessary operations and better adapt treatments to individual patients.

What is the procedure for the study?

The HELP-ER observational study is divided into two stages:

1. retrospective analysis

Data from 188 patients from the Tumor Bank Ovarian Cancer (TOC) network who have already had a second tumor removal (debulking surgery) for a recurrence will be analyzed. Clinical information and biomarker values are then combined to develop an algorithm to predict how successful a repeat operation might be. The AGO score serves as the basis for this analysis.

2. prospective testing of the algorithm

497 patients with a platinum-sensitive relapse are divided into two groups (cohorts) (as decided by the treating physicians):

• Cohort 1: receives conservative treatment or “wait-and-see strategy”
• Cohort 2: undergoing surgery

It is expected that at least 164 of the 497 patients (33%) will undergo a repeat operation. In approximately 131 of the operated patients (around 80 %), the tumor will be completely removed in order to validate the predictions of the algorithm.

Are there any risks?

This is a purely observational study, i.e. the patients do not receive any additional medication or other treatment regimes. In this respect, the study participants are not exposed to any additional risks or side effects. You will be informed about possible risks and side effects associated with participation during an information session.

Conditions of participation

Women aged 18 and over can take part in this study, with:

• Recurrent ovarian cancer of epithelial origin
• Consent to the examination of previously taken tumor samples
• Existing blood sample taken before the operation