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Search / Trial NCT07027046

Application of da Vinci SP for Endometrial Cancer Surgical Staging

Launched by NATIONAL CANCER INSTITUTE, NAPLES · Jun 10, 2025

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to perform surgery for women with endometrial cancer, which is cancer that starts in the lining of the uterus. The surgery uses a special robotic system called the da Vinci SP platform to help doctors remove the cancer and check nearby lymph nodes, which are small glands that can show if the cancer has spread. The goal is to see how well this robotic approach works as part of the usual treatment.

Women aged 18 and older who have been diagnosed with endometrial cancer and are scheduled for surgery to stage their cancer (which means figuring out how far it has spread) may be eligible to join. To participate, they need to be generally healthy enough for surgery and able to give informed consent. During the surgery, the robot will assist with removing the uterus and possibly the ovaries and lymph nodes, depending on each patient’s situation. This study is not yet recruiting, but if you join, you can expect to have your surgery done with this advanced robotic technology and be followed closely afterward to see how well the treatment works and how you recover.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Age ≥ 18 years
  • Histologically confirmed endometrial carcinoma (including uterine carcinosarcoma)
  • Performance status (ECOG) 0 - 1
  • Patients undergoing staging surgery for endometrial cancer, including but not limited to robotic hysterectomy with bilateral salpingo-oophorectomy (ovarian preservation in selected patients is not an exclusion criterion) and possible sentinel lymph node biopsy/pelvic ± para-aortic lymphadenectomy
  • Signed informed consent to participate in the study
  • Exclusion Criteria:
  • Patients scheduled for an additional extra-genital surgical procedure during the staging surgery for endometrial carcinoma
  • Patients with anesthesiological contraindications to a minimally invasive approach
  • Synchronous tumor
  • Recurrence of endometrial carcinoma
  • Dementia or significantly altered mental status that may impair understanding and the ability to provide informed consent
  • Any reason that may interfere with regular follow-up, even if limited to the first 30 days post-surgery

About National Cancer Institute, Naples

The National Cancer Institute (NCI) in Naples is a leading research institution dedicated to advancing the understanding and treatment of cancer through innovative clinical trials. As a prominent sponsor of cancer research, the NCI focuses on developing novel therapies, improving patient outcomes, and exploring cutting-edge methodologies in oncology. With a commitment to scientific rigor and collaboration, the NCI in Naples engages in partnerships with academic institutions and healthcare providers to facilitate groundbreaking studies that address critical challenges in cancer care. Their mission is to translate research findings into effective treatments, ultimately enhancing the lives of patients affected by cancer.

Locations

Milano, , Italy

Roma, , Italy

Patients applied

0 patients applied

Trial Officials

Vito Chiantera, MD

Principal Investigator

IRCCS I.N.T. "G. Pascale"

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported