Clinical trial · Observational
Sentinel Node Mapping in Women With Cervical and Endometrial Cancer
Sentinel Node Mapping With Robotic Assisted Near Infra-red Fluorescent Imaging in Women With Cervical and Endometrial Cancer
NCT02825355CI-TRIAL-00058677SENTIREC IcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to evaluate the effect of SLN mapping on the incidence and severity of lymphedema in women with early stage cervical and 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 |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
| Uterine Neoplasms | Uterine Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Patients with cervical cancer
- description
- All patients receive sentinel node mapping as the conventional treatment.
- label
- Patients with endometrial cancer
- description
- All patients receive sentinel node mapping as the conventional treatment.
Primary outcomes (2)
- measure
- Incidence of lymphedema
- timeFrame
- 3 years
- description
- Incidence of lymphedema will be assessed using patient reported outcome measures.
- measure
- Severity of lymphedema
- timeFrame
- 3 years
- description
- Severity of lymphedema will be assessed using patient reported outcome measures.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Study IA: Cervical carcinoma, FIGO stage IB1, cervical tumour size \< 2 cm * Study IB: Endometrial adenocarcinoma, presumed FIGO stage I, low- and intermediate risk: Type 1 grade 1 + 2, \> 50% myometrial invasion Exclusion Criteria: * Prior PL * Known allergy towards ICG and/or iodine (ICG contains 5% sodium iodine) * Women included in other studies affecting outcome-measures of the present study
References
Publications (1)
- DERIVEDBjornholt SM, Sponholtz SE, Markauskas A, Froding LP, Larsen CR, Fuglsang K, Schledermann D, Mogensen O, Jensen PT. Sentinel lymph node mapping for endometrial and cervical cancer in Denmark. Dan Med J. 2021 Mar 24;68(4):A11200886. PMID 33829991