Gustavo Savino
Roma, Rome, 00168, Italy
Location status: Recruiting
NCT Number: NCT05797415
The study involves enrollment of patients with sebaceous carcinoma, Merkel's carcinoma, Porocarcinoma, Melanoma, and squamous cell Ca of the ocular surface and adnexa both primary and relapsed after surgical and/or radiation-chemotherapy treatment at the Fondazione Policlinico Universitario A. Gemelli, IRCCS. The study will last 9 years: 1 year will be devoted to the first phase of the study. Patient enrollment will continue for an additional 3 years, and 5 years will be devoted overall to patient follow-up so that survival outcomes at 1-3 and 5 years can be assessed in a congruent number of patients. A preliminary analysis of the data at 1 year (pilot phase), an analysis at 4 years to confirm the preliminary study data on a larger sample, and a final analysis to evaluate OS and PFS at the 3 time-points indicated are planned.
Interested in participating?
Request Info18 year–95 year
All sexes
Observational
Roma, Rome, 00168, Italy
Location status: Recruiting
Patients will undergo:
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 9 years
Positive predictive value (PPV) and negative predictive value (NPV), in percentage, in order to determine the likelihood of lymphoscintigraphic examination and SLN biopsy in diagnosing Ocular Surface and Adnexal Cancers.
Time frame: 9 years
Sensitivity and sensibility, in percentage, in order to determine the likelihood of lymphoscintigraphic examination and SLN biopsy in diagnosing Ocular Surface and Adnexal Cancers.
Time frame: 5 years
OS (in years) at 1, 3, and 5 years
Time frame: 5 years
DFS (in years) at 1,3 and 5 years
Time frame: 5 years
PFS (in years) at 1, 3, and 5 years
Time frame: 60 months
Changes in clinical parameter (tumor diameters) of patients at follow-up (3, 6, 12, 24, 36, 48, 60 months)
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers: Prospective Observational Study
Acronym: BLS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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