Clinical trial · Observational
Prediction of Recurrence Among Low Risk Endometrial Cancer Patients
Prediction of Recurrence Among Low Risk Endometrial Cancer Population
NCT04604613CI-TRIAL-00104988active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
This study investigates whether molecular testing can help to predict the risk of endometrial cancer coming back (recurrence) after treatment in patients diagnosed with low risk endometrial cancer and scheduled to have surgery to remove the uterus and/or cervix (hysterectomy). Having sentinel lymph node mapping performed may help researchers to see if the cancer has spread in patients with low risk endometrial cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma | FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma | FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bilateral Salpingectomy with Oophorectomy | Procedure | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Hysterectomy | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Lymph Node Mapping | Procedure | — | UNRESOLVED |
| Sentinel Lymph Node Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-Correlative (biospecimen collection, node mapping)
- description
- Patients undergo hysterectomy and sentinel lymph node mapping. Patients may also undergo bilateral salpingo-oophorectomy at the direction of the treating physician. If peritoneal disease or other contraindications to lymphatic mapping are detected at the time of surgery, mapping and sentinel node biopsy are performed at the surgeon's discretion. At the time of hysterectomy, patients undergo collection of tissue for molecular testing. Before and after surgery, patients also undergo collection of blood samples for tumor marker analysis.
- interventionNames
- Procedure: Bilateral Salpingectomy with Oophorectomy
- Procedure: Biospecimen Collection
- Procedure: Hysterectomy
- Other: Laboratory Biomarker Analysis
- Procedure: Lymph Node Mapping
- Procedure: Sentinel Lymph Node Biopsy
Primary outcomes (1)
- measure
- 2-year recurrence
- timeFrame
- At 2 years
- description
- Will validate a model's ability to predict 2-year recurrence in low-risk endometrial cancer patients.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed low grade (grade 1-2) endometrioid type adenocarcinoma * Candidate for surgery * No evidence of deep invasion or peritoneal disease in patients that have undergone preoperative imaging * Patients may have had prior hormonal treatment for the treatment of early endometrial neoplasia. Patients may not have had prior radiation or chemotherapy for treatment of endometrial cancer * Patients must have a negative pregnancy if of childbearing potential Exclusion Criteria: * Histologically confirmed high grade endometrioid or non-endometrioid type endometrial cancer (including serous, clear cell, carcinosarcoma or any mixed tumor containing these cell types) * Medical co-morbidities making surgery unsafe, as determined by the primary treating physician * Evidence of deep myometrial invasion, cervical involvement or peritoneal disease on preoperative imaging * Prior treatment with radiation or chemotherapy for endometrial cancer * Any contraindication to lymph node mapping
References
Publications (0)
Data not yet available
No reference posted for this study.