Sentinel Lymph Node Biopsy Clinical Trial
Official title:
Sentinel Node Detection in Cervical Cancer
Evaluation of sensitivity of Sentinel lymph nodes for detecting nodal metastases in cervical cancer
Consecutive women with stage 1a2-2a1 cervical cancer scheduled for surgery will be approached
for eligibility by defined criteria.
Sentinel nodes will be detected by a combined use of Indocyanine green and Tc99 radiocolloid
( first 75 patients) and for the continuation with either the combined use or the best
performing of those tracers.
Technical success rates, adverse events (related study intervention and overall) sensitivity
and negative predictive values will be estimated.
An interim analyse will be performed after 34 node positive patients based on the Fleming two
stage analyse. The null hypothesis of sensitivity of 85% will be tested against an estimated
sensitivity of 95%. At this stage the study may be closed for futility, closed as hull
hypothesis is rejected or continued to reach another 28 node positive patients.
As a full pelvic lymphadenectomy will be performed after detection of sentinel nodes patient
will act ast their own controls.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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| Terminated |
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N/A | |
| Completed |
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||
| Active, not recruiting |
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The Validation of Sentinel Lymph Node Biopsy After Neo-adjuvant Chemotherapy in Breast Cancer Patients
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| Recruiting |
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Application of Preoperative Axillary Lymph Node Marking With Nano-Carbon in Breast Cancer Patients Before Neoadjuvant Chemotherapy
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N/A | |
| Recruiting |
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Phase 4 | |
| Not yet recruiting |
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N/A | |
| Completed |
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A Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems (SPY-PHI) in the Visualization of Lymphatic Vessels and Identification of Lymph Nodes During Sentinel Lymph Node Biopsy in Subjects With Breast Cancer
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Phase 3 | |
| Recruiting |
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The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.
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| Not yet recruiting |
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| Enrolling by invitation |
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The Combination of Preoperative MRI and SLN in the Surgical Management of CC and EC
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N/A | |
| Recruiting |
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N/A | |
| Recruiting |
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N/A | |
| Terminated |
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Phase 2 |