NCT04972682Completed
[SENTRY] Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer
Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer: a Prospective Open-label Single-arm Clinical Trial
Source: ClinicalTrials.gov · Last updated 7 May 2024
Brief summary (registry, in English)
While total hysterectomy without lymph node staging is standard for low- and intermediate-risk endometrial cancer, certain histopathologic factors can necessitate additional interventions. Our study assesses the influence of sentinel lymph node (SLN) biopsy on postoperative decision-making.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 102 (actual)
- First submitted
- 12 Jul 2021
- Start date
- 1 Jul 2021
- Primary completion date
- 15 Aug 2023
- Lead sponsor
- Moscow City Oncology Hospital No. 62
- Diseases
- Endometrial cancer
- NCT number
- NCT04972682
What you commit to
- Study type: Interventional
- Participants enrolled: 102
- From 1 Jul 2021 to the primary completion date, 15 Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pelvic or retroperitoneal LND
- Contraindications to surgical treatment
Other illness
- Preoperative treatment of endometrial cancer including radiotherapy, systemic chemotherapy, or hormone therapy
- History of surgeries on the uterus and uterine appendages, with exceptions such as cesarean section, tubectomy, oophorectomy, ovarian resection, ovarian biopsy, and ovarian cauterization
- Allergy to iodine-containing drugs
Age
- • Age <18 years
Other
- Presence of tumor spread outside the corpus uteri
- Absence of tumor invasion into the myometrium
- High-grade tumor (G3)
- Bokhman type 2 tumor (e.g., clear cell adenocarcinoma, serous adenocarcinoma, carcinosarcoma, endometrial stromal sarcoma)
- Lack of signed informed consent
Who the study is looking for
- Age ≥18 years
- Histologically verified low-grade endometrioid adenocarcinoma of the endometrium (G1-G2)
- FIGO stage IA
- FIGO stage IB and II when LND is contraindicated
- No contraindications for surgery
- Signed informed consent
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 1. Department of Gynecologic Oncology, Moscow City Oncology Hospital No. 62 Coordinator of this site? Confirm its status | Istra | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.