Exploring molecular classification in fertility-sparing treatment for endometrial cancer
Prognostic Role of molEcular classiFication in Fertility-sparing treAtment of Endometrial canCEr: PREFACE Study
This study is testing how different genetic types of early-stage endometrial cancer can help doctors choose the best fertility-sparing treatments for women aged 18-45 who want to keep their ability to have children.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Locations | 1 site (Milano, MI) |
| Trial ID | NCT06799624 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the prognostic role of molecular classifications in guiding fertility-sparing treatments for women with early-stage endometrial cancer. It focuses on patients aged 18-45 who have a confirmed diagnosis and desire to preserve their fertility. The study aims to analyze how different molecular subtypes, identified through next-generation sequencing, impact treatment outcomes and response rates. By understanding these classifications, the research seeks to personalize treatment approaches for better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-45 with early-stage endometrial cancer who wish to preserve their fertility.
Not a fit: Patients with atypical endometrial hyperplasia, non-endometrioid histology, or those with medical contraindications to hormonal therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized fertility-sparing treatment options for women with endometrial cancer.
How similar studies have performed: Previous studies have shown promise in using molecular profiling to guide treatment in endometrial cancer, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 18-45 years with a hysteroscopic confirmed diagnosis of endometrial cancer (FIGO stage IA without myometrial invasion, grade 1 or grade 2, endometrioid histology). 2. Patients desiring fertility preservation 3. Molecular classification of the tumor using next-generation sequencing (NGS) or Proactive Molecular Risk Classifier for Endometrial Cancer (ProMisE). 4. Adequate pre-treatment imaging (MRI or transvaginal ultrasound) confirming no evidence of myometrial invasion or extrauterine spread. Exclusion Criteria: 1. Patients with atypical endometrial hyperplasia or intraepithelial neoplasia 2. Individuals with tumor samples of insufficient quantity or inadequate quality were not included in the analysis 3. Non-endometrioid histology. 4. Patients with a history of prior uterine malignancy or current synchronous malignancies. 5. Medical contraindications to hormonal therapy
Where this trial is running
Milano, MI
- Fondazione IRCCS Istituto Nazionale dei Tumori di Milano — Milano, Mi, Italy (Recruiting)
Study contacts
- Study coordinator: Giorgio Bogani, MD
- Email: bogani.giorgio@gmail.com
- Phone: 3803933116
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.