Sentinel Lymph Node Clinical Trial
— SELLYOfficial title:
SEntine Lymph Node in earLY Ovarian Cancer
Verified date | June 2023 |
Source | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The present study aims at investigating the feasibility, the detection rate and the negative predictive value of sentinel node in predicting the presence or absence of lymph node metastasis in ovarian cancer patients
Status | Completed |
Enrollment | 176 |
Est. completion date | May 5, 2023 |
Est. primary completion date | July 29, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Epithelial ovarian cancer - Early stage disease limited to the ovary Exclusion Criteria: - Evidence of extraovarian disease - Allergy to the materials used |
Country | Name | City | State |
---|---|---|---|
Italy | Giovannni Scambia | Rome |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
Nyberg RH, Korkola P, Maenpaa JU. Sentinel Node and Ovarian Tumors: A Series of 20 Patients. Int J Gynecol Cancer. 2017 May;27(4):684-689. doi: 10.1097/IGC.0000000000000948. — View Citation
Sadeghi R. Feasibility of Sentinel Node Mapping in Ovarian Tumors: What Is the Evidence? Int J Gynecol Cancer. 2018 Feb;28(2):421-422. doi: 10.1097/IGC.0000000000001158. No abstract available. — View Citation
Uccella S, Gisone B, Stevenazzi G, Ghezzi F. Laparoscopic sentinel node detection with ICG for early ovarian cancer: Description of a technique and literature review. Eur J Obstet Gynecol Reprod Biol. 2018 Feb;221:193-194. doi: 10.1016/j.ejogrb.2017.12.00 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with procedure-related adverse events | The number of patients with procedure-related adverse events as assessed by CTCAE v4.0 | 6 months | |
Primary | Detection rate | The rate of patients in whom the sentinel node is detected | 24 months | |
Secondary | Negative predictive value | The negative predictive value of sentinel node in assessing nodal status | 24 months |
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