Clinical trial · Interventional
Analysis of Molecular Biomarkers in Periocular Adnexal Tumours
NCT06080009CI-TRIAL-00074286unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to collect sebaceous carcinomas from the Fondazione Policlinico Gemelli retrospectively and prospectively, to analyse them morphologically and immunopathologically and to correlate them with molecular genetic aspects. This study will help to clarify and develop a more effective multidisciplinary diagnostic-therapeutic pathway.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sebaceous Cell Tumor of Eyelid | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exome sequencing (retrospective) and exome and methylome sequencing (prospective) | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients diagnosed with Ca sebaceous of the ocular adnexa.
- description
- adult patients diagnosed with Ca sebaceous of the ocular adnexa.
- interventionNames
- Genetic: exome sequencing (retrospective) and exome and methylome sequencing (prospective)
Primary outcomes (1)
- measure
- Concentration of different molecules in Microscopic and immunophenotypic analysis
- timeFrame
- 1 year
- description
- Tissue samples will then be sent for single and/or multiple immunohistochemistry.
Secondary outcomes (2)
- measure
- Rate of somatic variants, variants with loss of heterozygosity, global mutational signature and identification of probable driver mutations
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older; * Diagnosis of sebaceous Ca of the ocular adnexa * Ability to obtain formalin-fixed and paraffin-embedded primary and/or metastatic tumour tissue (FFPE) and healthy tissue * Availability of primary and/or metastatic tumour tissue in paraffin-embedded or OCT (prospective part) and healthy tissue * Written informed consent for use of data for research purposes. Exclusion Criteria: * Age \< 18 years; * Lack of sufficient clinical data on selected patients. * Lack of tumor and/or metastatic tissue in kerosene or OCT. * Refusal to give informed consent to data processing for research purposes.
References
Publications (13)
- BACKGROUNDPrieto-Granada C, Rodriguez-Waitkus P. Sebaceous Carcinoma of the Eyelid. Cancer Control. 2016 Apr;23(2):126-32. doi: 10.1177/107327481602300206. PMID 27218789
- BACKGROUNDOwen JL, Kibbi N, Worley B, Kelm RC, Wang JV, Barker CA, Behshad R, Bichakjian CK, Bolotin D, Bordeaux JS, Bradshaw SH, Cartee TV, Chandra S, Cho NL, Choi JN, Council ML, Demirci H, Eisen DB, Esmaeli B, Golda N, Huang CC, Ibrahim SF, Jiang SB, Kim J, Kuzel TM, Lai SY, Lawrence N, Lee EH, Leitenberger JJ, Maher IA, Mann MW, Minkis K, Mittal BB, Nehal KS, Neuhaus IM, Ozog DM, Petersen B, Rotemberg V, Samant S, Samie FH, Servaes S, Shields CL, Shin TM, Sobanko JF, Somani AK, Stebbins WG, Thomas JR, Thomas VD, Tse DT, Waldman AH, Wong MK, Xu YG, Yu SS, Zeitouni NC, Ramsay T, Reynolds KA, Poon E, Alam M. Sebaceous carcinoma: evidence-based clinical practice guidelines. Lancet Oncol. 2019 Dec;20(12):e699-e714. doi: 10.1016/S1470-2045(19)30673-4. PMID 31797796
- BACKGROUNDAlfaar AS, Suckert CN, Rehak M, Girbardt C. The epidemiology of adults' eyelid malignancies in Germany between 2009 and 2015; An analysis of 42,710 patients' data. Eur J Ophthalmol. 2022 Nov 4;33(2):11206721221125018. doi: 10.1177/11206721221125018. Online ahead of print. PMID 36330713
- BACKGROUNDTryggvason G, Bayon R, Pagedar NA. Epidemiology of sebaceous carcinoma of the head and neck: implications for lymph node management. Head Neck. 2012 Dec;34(12):1765-8. doi: 10.1002/hed.22009. Epub 2012 Jan 20. PMID 22267270
- BACKGROUNDGauthier AS, Campolmi N, Tumahai P, Kantelip B, Delbosc B. Sebaceous carcinoma of the eyelid and Muir-Torre syndrome. JAMA Ophthalmol. 2014 Aug;132(8):1025-8. doi: 10.1001/jamaophthalmol.2014.1026. No abstract available. PMID 24969841
- BACKGROUNDFerreira I, Wiedemeyer K, Demetter P, Adams DJ, Arends MJ, Brenn T. Update on the pathology, genetics and somatic landscape of sebaceous tumours. Histopathology. 2020 Apr;76(5):640-649. doi: 10.1111/his.14044. Epub 2020 Mar 17.