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| Name | Class |
|---|---|
| Hospital Universitario La Fe | OTHER |
| Hospital Clinic of Barcelona | OTHER |
| Hospital Universitario 12 de Octubre | OTHER |
| Hospital Universitario La Paz |
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This clinical trial investigates the sentinel lymph node (SLN) technique as a less invasive alternative to conventional lymphadenectomy in patients with early-stage ovarian cancer. The primary objective is to evaluate the effectiveness, safety, and diagnostic accuracy of the SLN approach in detecting lymphatic metastases. By assessing its negative predictive value, the study aims to determine whether the SLN technique can reliably replace systematic pelvic and paraaortic lymphadenectomy. If successful, this technique could minimize surgical morbidity, shorten hospitalization stays, and lower complication rates, ultimately improving patient outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women >18, with confirmed early-stage ovarian cancer, undergoing staging surgery. | Experimental | A 0.2 ml (27 mBq) dose of 99mTc and 0.5 ml (1.25 mg/ml) of ICG is injected subperitoneally in the dorsal or ventral side of the pelvic infundibulum stump, and 0.2 ml (27 mBq) of 99mTc and 1 ml (1.25 mg/ml) of ICG intracervically. Sentinel nodes are located using the auditory signal from the gamma probe and visually via ICG staining with an infrared light system. After 30 minutes, all identified nodes are removed. Deferred histology applies ultra-staging for negative or micrometastatic nodes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentinel Node Technique | Procedure | A 0.2 ml (27 mBq) dose of 99mTc and 0.5 ml (1.25 mg/ml) of ICG is injected subperitoneally in the dorsal or ventral side of the pelvic infundibulum stump, and 0.2 ml (27 mBq) of 99mTc and 1 ml (1.25 mg/ml) of ICG intracervically. Sentinel nodes are located using the auditory signal from the gamma probe and visually via ICG staining with an infrared light system. After 30 minutes, all identified nodes are removed. Deferred histology applies ultra-staging for negative or micrometastatic nodes. |
| Measure | Description | Time Frame |
|---|---|---|
| Negative predictive value of the sentinel lymph node technique. | To determine the negative predictive value of the sentinel lymph node technique for detecting lymph node metastases, using pelvic/aortic lymphadenectomy as the Gold Standard. | Postoperative (30 days +/- 10 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance of Sentinel Lymph Node Technique vs. Lymphadenectomy | Evaluate the degree of concordance (sensitivity, specificity, positive predictive value, and diagnostic accuracy) between the sentinel lymph node technique and pelvic/aortic lymphadenectomy (Gold Standard) for detecting lymph node metastasis. | Postoperative (30 days +/- 10 days). |
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Inclusion Criteria:
Exclusion Criteria:
Patients who have signed informed consent but do not meet all inclusion criteria and none of the exclusion criteria will be considered as selection failures.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mónica Cebrián Coordinator Clinical Research Area | Contact | +34961246731 | investigacion_clinica@iislafe.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario y Politécnico La Fe | Recruiting | Valencia | Valencia | 46026 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41763980 | Derived | Lago V, Rey I, Diaz-Feijoo B, Torrent A, Tejerizo A, Muruzabal JC, Veiga-Fernandez A, Utrilla-Layna J, Chacon E, Angeles MA, Diestro MD, Sainz de la Cuesta R, Padilla-Iserte P, Montero B, Dawid De Vera T, Vera V, Domingo S. Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II). Int J Gynecol Cancer. 2025 Nov 21:102821. doi: 10.1016/j.ijgc.2025.102821. Online ahead of print. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| OTHER |
| Hospital General Universitario Gregorio Marañon | OTHER |
| Quirón Madrid University Hospital | OTHER |
| Hospital of Navarra | OTHER |
| Hospital Son Espases | OTHER |
| Hospital Universitari de la Vall de Hebron | UNKNOWN |
| Hospital Universitario Fundación Jiménez Díaz | OTHER |
| Clinica Universidad de Navarra, Universidad de Navarra | OTHER |
Controlled, prospective, descriptive and not randomized
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|
| Characterize Sentinel Lymph Node Technique vs. Lymphadenectomy for Metastasis Detection | Characterize the sentinel lymph node technique for detecting lymph node metastasis using pelvic/aortic lymphadenectomy as the Gold Standard in terms of sensitivity, specificity, positive and negative predictive value, positive and negative likelihood ratios, and effectiveness. | Intraoperative and postoperative (30 days +/- 10 days). |
| Sample Characterization | Characterize the sample (through collection of baseline characteristics, medical history, tumor markers, intraoperative findings, surgical procedures, and immediate admission data). | Baseline visit and Intraoperative |
| Characterize Sentinel Lymph Node Technique Based On Site of Drug Injection | Characterize the sentinel lymph node technique for detecting lymph node metastasis based on the site of drug injection, using lymphadenectomy as the Gold Standard, in terms of sensitivity, specificity, positive and negative predictive value, positive and negative likelihood ratios, and effectiveness. | Intraoperative and postoperative (30 days +/- 10 days). |
| Determine Sentinel Lymph Node Procedure Rate | Determine the sentinel lymph node procedure rate. | Intraoperative and postoperative (30 days +/- 10 days). |
| Determine the rate of "empty" sentinel lymph node detection. | Determine the rate of "empty" sentinel lymph node detection. | Postoperative (30 days +/- 10 days). |
| Determine Pelvic and/or Paraaortic Sentinel Lymph Node Detection Rate | Determine the detection rate of pelvic and/or paraaortic sentinel lymph nodes. | Intraoperative and postoperative (30 days +/- 10 days). |
| Identify the anatomical location of the sentinel lymph nodes. | Identify the anatomical location of the sentinel lymph nodes. | Intraoperative and postoperative (30 days +/- 10 days). |
| Determine the number of detected lymph nodes. | Determine the number of detected lymph nodes. | Intraoperative and postoperative (30 days +/- 10 days). |
| Rate of overstaging with ultrastaging. | Rate of overstaging with ultrastaging. | Postoperative (30 days +/- 10 days). |
| Complications related to the sentinel lymph node technique | Complications related to the sentinel lymph node technique. | Intraoperative and postoperative (30 days +/- 10 days). |
| Complications related to lymphadenectomy. | Complications related to lymphadenectomy. | Intraoperative and postoperative (30 days +/- 10 days). |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |