Personalized treatment for endometrial cancer using biomarkers

Biomarker Guided Treatment in Gynaecological Cancer

This study tests if using specific biomarkers can help doctors personalize treatment for patients with endometrial cancer to improve their care.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1300 (estimated)
• Ages: 18 Years to 95 Years
• Sex: Female
• Sponsor: Haukeland University Hospital (Academic / other)
• Locations: 9 sites (Nijmegen and 8 other locations)
• Trial ID: NCT02543710 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of using identified molecular biomarkers to tailor treatment for patients with endometrial cancer. It consists of two parts: the first focuses on optimizing surgical treatment through lymphadenectomy guided by validated biomarkers, while the second assesses the predictive potential of the biomarker stathmin for response to taxane treatment in endometrial and ovarian cancer. The goal is to enhance treatment individualization based on biomarker profiles.

Who should consider this trial

Good fit: Ideal candidates include patients with suspected or confirmed endometrial cancer who are eligible for surgical treatment or advanced patients with endometrial or epithelial ovarian cancer requiring taxane therapy.

Not a fit: Patients without endometrial or epithelial ovarian cancer, those under 18, or those unable to provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients with endometrial cancer.

How similar studies have performed: Other studies have shown promise in using biomarkers for treatment personalization, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria part 1:

All patients referred to a participating research centre with suspicion of or confirmed endometrial cancer.

Exclusion Criteria part 1:

1. Patients who do not have endometrial cancer
2. Patients who will or cannot give informed consent (including language barriers)
3. Patients \<18 years of age
4. Patients who will not get surgical treatment for their endometrial cancer

Inclusion criteria part 2:

1. Patients with endometrial or epithelial ovarian cancer who following routine clinical guidelines are offered weekly taxane (paclitaxel) treatment. This will often be a third or fourth line treatment, i.e. patients with advanced disease.
2. Technical possibility to obtain a new tissue biopsy to determine stathmin level in the tumour recurrence.

Exclusion criteria part 2:

1. Patients not suffering from endometrial or epithelial ovarian cancer
2. Patients \<18 years of age
3. Patients who do not agree to the proposed treatment or will receive (part of) the treatment in a non-participating centre
4. Patients who cannot or do not want to give informed consent (including language barriers)

Where this trial is running

Nijmegen and 8 other locations

• Radboud university hospital — Nijmegen, Netherlands (Not_yet_recruiting)
• Women's hospital, Haukeland university hospital — Bergen, Hordaland, Norway (Recruiting)
• Ålesund hospital — Ålesund, Norway (Recruiting)
• Førde central hospital — Førde, Norway (Recruiting)
• Sørlandet hospital — Kristiansand, Norway (Not_yet_recruiting)
• Akershus University hospital — Oslo, Norway (Recruiting)
• Stavanger university hospital — Stavanger, Norway (Recruiting)
• St Olav university hospital — Trondheim, Norway (Recruiting)
• Spsk No 1 — Lublin, Poland (Recruiting)

Study contacts

• Principal investigator: Henrica MJ Werner, MD PhD MRCOG — Haukeland University Hospital
• Study coordinator: Jone Trovik, MD PhD Prof

Conditions Endometrial Cancer