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This research study evaluates the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.
The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with early stage ovarian cancer.
With this research study it will be evaluated the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with ovarian cancer | Experimental | Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sentinel node technique | Other | Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of performing the sentinel node technique (Detection rate) | The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with previous ovarian surgery injecting the tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection. | Intraoperative (day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of realization of the technique | Intraoperative (day 0) | |
| Rate of realization of the technique | After anatomopathological study (day 30) | |
| Anatomical location of the sentinel node(s) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor Lago | Instituto de Investigación Sanitaria La Fe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario y Politécnico La Fe | Valencia | 46026 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33712275 | Derived | Lago V, Montero B, Lopez S, Padilla-Iserte P, Matute L, Marina T, Gurrea M, Montoliu G, Bello P, Domingo S. Ultrastaging protocol in sentinel lymph node for apparent early stage ovarian cancer. Gynecol Oncol. 2021 May;161(2):408-413. doi: 10.1016/j.ygyno.2021.03.001. Epub 2021 Mar 10. | |
| 32448808 | Derived | Lago V, Bello P, Montero B, Matute L, Padilla-Iserte P, Lopez S, Marina T, Agudelo M, Domingo S. Sentinel lymph node technique in early-stage ovarian cancer (SENTOV): a phase II clinical trial. Int J Gynecol Cancer. 2020 Sep;30(9):1390-1396. doi: 10.1136/ijgc-2020-001289. Epub 2020 May 23. |
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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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Controlled, prospective, descriptive and not randomized
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Assessed by radiation (99Tc-nanocoloides) and staining with indocyanine green |
| Intraoperative (day 0) |
| Anatomical location of the sentinel node(s) | Assessed by the pathologist | After anatomopathological study (day 30) |
| Number of detected sentinel nodes | Intraoperative (day 1) |
| Number of detected sentinel nodes | After anatomopathological study (day 30) |
| Characterization of the sample by collecting baseline characteristics | Age (years) | Screening (day 0) |
| Characterization of the sample by collecting baseline characteristics | Weight (kilograms) | Screening (day 0) |
| Characterization of the sample by collecting baseline characteristics | Height (centimeters) | Screening (day 0) |
| Characterization of the sample by collecting baseline characteristics | BMI (kg/m^2) | Screening (day 0) |
| Characterization of the sample by collecting baseline characteristics | Previous gynecological surgery and previous pathological anatomy | Screening (day 0) |
| Characterization of the sample by collecting tumor markers | Ca 125 and Ca 19.9. | Day 0 |
| Characterization of the sample by collecting intraoperative findings | Ascites (milliliters) | Day 0 |
| Characterization of the sample by collecting intraoperative findings | Tumor size (centimeters) of: right ovary, left ovary, right tube, left tube, uterus, pelvic nodes, para-aortic nodes, and tumor in upper hemiabdomen. | Day 0 |
| Characterization of the sample by collecting surgical procedures | Hysterectomy, adnexectomy, appendectomy, peritonectomy / peritoneal biopsy, omentectomy, lymphadenectomy and blood transfusion (Realized or Unrealized) | Day 0 |
| Characterization of the sample by collecting surgical procedures | Intraoperative complications | Day 0 |
| Characterization of the sample by collecting surgical procedures | Result of intraoperative biopsy (unrealized, malignant, benign) | Day 0 |
| Characterization of the sample by collecting surgical procedures | Estimated blood loss (milliliters) | Day 0 |
| Characterization of the sample by collecting surgical procedures | Surgical time (minutes) | Day 0 |
| 31628986 | Derived | Lago V, Bello P, Matute L, Padilla-Iserte P, Marina T, Agudelo M, Domingo S. Sentinel Lymph Node Technique in Apparent Early Ovarian Cancer: Laparoscopic Technique. J Minim Invasive Gynecol. 2020 Jul-Aug;27(5):1019-1020. doi: 10.1016/j.jmig.2019.09.790. Epub 2019 Oct 16. |
| 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 |