Ocular Sebaceous CarcinomaBLSNCT05797415
Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers
An observational study of Ocular Sebaceous Carcinoma and Ocular Basal Cell Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Ocular Sebaceous Carcinoma, Ocular Basal Cell Carcinoma, Ocular Surface Squamous Neoplasia
- What is being tested?
- Sentinel Lymph Node Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 15 Mar 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Adult, Older adult
Study population: 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 Fondazione Policlinico Universitario A.Gemelli IRCCS will be enrolled in the study.
Who may be able to join
- All patients with Porocarcinoma, Ca of Merkel, Ca Sebaceous
- Patients with cutaneous adnexal melanoma with thickness ≥1.5 mm, Clark's level ≥3, >1 mitotic figure per high-power field.
- Patients with conjunctival melanoma both primary and recurrent and associated with primary acquired melanosis with atypia.
- Patients with squamous cell Ca of adnexa with Staging ≥3, locally recurrent or with perineural invasion
- Patients with squamous cell Ca of the surface with Staging ≥3 and/or multicenter
- Signature of informed consent to participate in the study
- cNo
Who cannot join
- Age less than 18 years
- Patients with metastatic disease at diagnosis
- All patients who do not fit the inclusion criteria
- Failure to obtain informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Gustavo Savino
Roma, Rome, 00168
Gustavo Savino, MD, +390630154528, oncologiaoculare@policlinicogemelli.it
About this study
Official title: Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers: Prospective Observational Study
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.
Read the detailed description
Patients will undergo:
- Evaluation in the ocular oncology outpatient clinic with examination and anterior segment photography
- Staging according to TNM AJCC 8th edition by incisional biopsy (if necessary after clinical evaluation) and/or excisional biopsy and imaging to be performed in current clinical practice (MRI with mdc orbits, massif and neck + Tc/Pet total body)
- Injection of 99mTc-labeled nanocolloids
- Preoperative lymphoscintigraphy
- Intraoperative search by gamma probe of the sentinel lymph node
- Sentinel lymph node biopsy
- Excisional biopsy of the neoformation in cases not undergoing excision before SLN biopsy.
- In case of SLN histologic positivity, the multidisciplinary team will consider whether to refer the patient for parotidectomy and excision of the lymph node chain and/or adjuvant radio/chemotherapy.
- Clinical-instrumental follow-up to be performed in current clinical practice (Clinical examination, cranial orbit and neck MRI, total body CT scan) at 3, 6, 12, 18, 24, 36, 48, 60 months or according to periodicity assessed on a case-by-case basis by the Tumor Board.
- Conditions
- Ocular Sebaceous Carcinoma, Ocular Basal Cell Carcinoma, Ocular Surface Squamous Neoplasia, Merkel Cell Carcinoma, Unspecified, Porocarcinoma, Conjunctival Melanoma
- Being tested
- Sentinel Lymph Node Biopsy
- Keywords
- Sentinel Lymph Node Biopsy, Malignant ocular surface tumors, Malignant eyelids tumors
- Medical subject headings
- Carcinoma, Merkel Cell, Eccrine Porocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Lymph Node BiopsyProcedure or surgery
- Injection of 99mTc-labeled nanocolloids
- Preoperative lymphoscintigraphy
- Intraoperative gamma probe search of the sentinel lymph node
- Sentinel lymph node biopsy
- Excisional biopsy of the neoformation in cases not undergoing excision before SLN biopsy.
- If the SLN is histologically positive, the multidisciplinary team will consider whether to refer the patient for parotidectomy and excision of the lymph node chain and/or adjuvant radio/chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Sebaceous carcinoma | patients with sebaceous carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS Receives: Procedure: Sentinel Lymph Node Biopsy | |
| Merkel's carcinoma | patients with Merkel's carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS Receives: Procedure: Sentinel Lymph Node Biopsy | |
| Porocarcinoma | patients with Porocarcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS Receives: Procedure: Sentinel Lymph Node Biopsy | |
| Conjunctival Melanoma | patients with Conjunctival Melanoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS Receives: Procedure: Sentinel Lymph Node Biopsy | |
| Squamous cell Carcinoma | patients with squamous cell Carcinoma of the ocular surface and adnexa both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS Receives: Procedure: Sentinel Lymph Node Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of lymphoscintigraphic examination and SLN biopsy
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.
Measured: 9 years
Efficacy of lymphoscintigraphic examination and SLN biopsy
Sensitivity and sensibility, in percentage, in order to determine the likelihood of lymphoscintigraphic examination and SLN biopsy in diagnosing Ocular Surface and Adnexal Cancers.
Measured: 9 years
Secondary outcomes (4)
Overall survival (OS)
OS (in years) at 1, 3, and 5 years
Measured: 5 years
Diseases Free Survival (DFS)
DFS (in years) at 1,3 and 5 years
Measured: 5 years
Progression Free Survival (PFS)
PFS (in years) at 1, 3, and 5 years
Measured: 5 years
Changes in clinical parameter (tumor diameters)
Changes in clinical parameter (tumor diameters) of patients at follow-up (3, 6, 12, 24, 36, 48, 60 months)
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start1 Mar 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion15 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Ocular Sebaceous CarcinomaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savino Gustavo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797415
- Sponsor's protocol ID
- 5572
- Acronym
- BLS
- Status last verified
- Sep 2024
- First submitted
- 6 Mar 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shields CL, Alset AE, Boal NS, Casey MG, Knapp AN, Sugarman JA, Schoen MA, Gordon PS, Douglass AM, Sioufi K, Say EA, Shields JA. Conjunctival Tumors in 5002 Cases. Comparative Analysis of Benign Versus Malignant Counterparts. The 2016 James D. Allen Lecture. Am J Ophthalmol. 2017 Jan;173:106-133. doi: 10.1016/j.ajo.2016.09.034. Epub 2016 Oct 8.
PubMed 27725148Shields CL, Shields JA. Tumors of the conjunctiva and cornea. Indian J Ophthalmol. 2019 Dec;67(12):1930-1948. doi: 10.4103/ijo.IJO_2040_19.
PubMed 31755426Esmaeli B, Wang B, Deavers M, Gillenwater A, Goepfert H, Diaz E, Eicher S. Prognostic factors for survival in malignant melanoma of the eyelid skin. Ophthalmic Plast Reconstr Surg. 2000 Jul;16(4):250-7. doi: 10.1097/00002341-200007000-00002.
PubMed 10923972Soysal HG, Markoc F. Invasive squamous cell carcinoma of the eyelids and periorbital region. Br J Ophthalmol. 2007 Mar;91(3):325-9. doi: 10.1136/bjo.2006.102673. Epub 2006 Oct 4.
PubMed 17020898Faustina M, Diba R, Ahmadi MA, Esmaeli B. Patterns of regional and distant metastasis in patients with eyelid and periocular squamous cell carcinoma. Ophthalmology. 2004 Oct;111(10):1930-2. doi: 10.1016/j.ophtha.2004.02.009.
PubMed 15465559Cervantes G, Rodriguez AA Jr, Leal AG. Squamous cell carcinoma of the conjunctiva: clinicopathological features in 287 cases. Can J Ophthalmol. 2002 Feb;37(1):14-9; discussion 19-20. doi: 10.1016/s0008-4182(02)80093-x.
PubMed 11865953Yousef YA, Finger PT. Squamous carcinoma and dysplasia of the conjunctiva and cornea: an analysis of 101 cases. Ophthalmology. 2012 Feb;119(2):233-40. doi: 10.1016/j.ophtha.2011.08.005. Epub 2011 Dec 20.
PubMed 22189448Esmaeli B, Eicher S, Popp J, Delpassand E, Prieto VG, Gershenwald JE. Sentinel lymph node biopsy for conjunctival melanoma. Ophthalmic Plast Reconstr Surg. 2001 Nov;17(6):436-42. doi: 10.1097/00002341-200111000-00010.
PubMed 11766025Freitag SK, Aakalu VK, Tao JP, Wladis EJ, Foster JA, Sobel RK, Yen MT. Sentinel Lymph Node Biopsy for Eyelid and Conjunctival Malignancy: A Report by the American Academy of Ophthalmology. Ophthalmology. 2020 Dec;127(12):1757-1765. doi: 10.1016/j.ophtha.2020.07.031. Epub 2020 Jul 19.
PubMed 32698034Chak G, Morgan PV, Joseph JM, Tao JP. A positive sentinel lymph node in periocular invasive squamous cell carcinoma: a case series. Ophthalmic Plast Reconstr Surg. 2013 Jan-Feb;29(1):6-10. doi: 10.1097/IOP.0b013e31826a50f7.
PubMed 23034693Maalouf TJ, Dolivet G, Angioi KS, Leroux A, Genin P, George JL. Sentinel lymph node biopsy in patients with conjunctival and eyelid cancers: experience in 17 patients. Ophthalmic Plast Reconstr Surg. 2012 Jan-Feb;28(1):30-4. doi: 10.1097/IOP.0b013e31822fb44b.
PubMed 22262287Savino G, Cuffaro G, Maceroni M, Pagliara MM, Sammarco MG, Giraldi L, Blasi MA. Advanced ocular surface squamous cell carcinoma (OSSC): long-term follow-up. Graefes Arch Clin Exp Ophthalmol. 2021 Nov;259(11):3437-3443. doi: 10.1007/s00417-021-05264-3. Epub 2021 Jul 20.
PubMed 34283293Esmaeli B, Nasser QJ, Cruz H, Fellman M, Warneke CL, Ivan D. American Joint Committee on Cancer T category for eyelid sebaceous carcinoma correlates with nodal metastasis and survival. Ophthalmology. 2012 May;119(5):1078-82. doi: 10.1016/j.ophtha.2011.11.006. Epub 2012 Feb 11.
PubMed 22330966
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05797415
- Acronym / sponsor ID
- BLS / 5572
- Conditions
- Ocular Sebaceous Carcinoma, Ocular Basal Cell Carcinoma, Ocular Surface Squamous Neoplasia, Merkel Cell Carcinoma, Unspecified, Porocarcinoma, Conjunctival Melanoma
- Keywords
- Sentinel Lymph Node Biopsy, Malignant ocular surface tumors, Malignant eyelids tumors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 15 Mar 2032 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will undergo:
- Evaluation in the ocular oncology outpatient clinic with examination and anterior segment photography
- Staging according to TNM AJCC 8th edition by incisional biopsy (if necessary after clinical evaluation) and/or excisional biopsy and imaging to be performed in current clinical practice (MRI with mdc orbits, massif and neck + Tc/Pet total body)
- Injection of 99mTc-labeled nanocolloids
- Preoperative lymphoscintigraphy
- Intraoperative search by gamma probe of the sentinel lymph node
- Sentinel lymph node biopsy
- Excisional biopsy of the neoformation in cases not undergoing excision before SLN biopsy.
- In case of SLN histologic positivity, the multidisciplinary team will consider whether to refer the patient for parotidectomy and excision of the lymph node chain and/or adjuvant radio/chemotherapy.
- Clinical-instrumental follow-up to be performed in current clinical practice (Clinical examination, cranial orbit and neck MRI, total body CT scan) at 3, 6, 12, 18, 24, 36, 48, 60 months or according to periodicity assessed on a case-by-case basis by the Tumor Board.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sebaceous carcinoma | – | Procedure: Sentinel Lymph Node Biopsypatients with sebaceous carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS |
| Merkel's carcinoma | – | Procedure: Sentinel Lymph Node Biopsypatients with Merkel's carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS |
| Porocarcinoma | – | Procedure: Sentinel Lymph Node Biopsypatients with Porocarcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS |
| Conjunctival Melanoma | – | Procedure: Sentinel Lymph Node Biopsypatients with Conjunctival Melanoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS |
| Squamous cell Carcinoma | – | Procedure: Sentinel Lymph Node Biopsypatients with squamous cell Carcinoma of the ocular surface and adnexa both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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 Fondazione Policlinico Universitario A.Gemelli IRCCS will be enrolled in the study.
Key inclusion criteria (7 listed)
- All patients with Porocarcinoma, Ca of Merkel, Ca Sebaceous
- Patients with cutaneous adnexal melanoma with thickness ≥1.5 mm, Clark's level ≥3, >1 mitotic figure per high-power field.
- Patients with conjunctival melanoma both primary and recurrent and associated with primary acquired melanosis with atypia.
- Patients with squamous cell Ca of adnexa with Staging ≥3, locally recurrent or with perineural invasion
- Patients with squamous cell Ca of the surface with Staging ≥3 and/or multicenter
Key exclusion criteria (4 listed)
- Age less than 18 years
- Patients with metastatic disease at diagnosis
- All patients who do not fit the inclusion criteria
- Failure to obtain informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel Lymph Node Biopsy* Injection of 99mTc-labeled nanocolloids * Preoperative lymphoscintigraphy * Intraoperative gamma probe search of the sentinel lymph node * Sentinel lymph node biopsy * Excisional biopsy of the neoformation in cases not undergoing excision before SLN biopsy. * If the SLN is histologically positive, the multidisciplinary team will consider whether to refer the patient for parotidectomy and excision of the lymph node chain and/or adjuvant radio/chemotherapy. | Procedure or surgery | Conjunctival Melanoma, Merkel's carcinoma, Porocarcinoma, Sebaceous carcinoma, Squamous cell Carcinoma |
Primary outcome
Efficacy of lymphoscintigraphic examination and SLN biopsy
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.
Efficacy of lymphoscintigraphic examination and SLN biopsy
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.
4 secondary outcomes
Overall survival (OS)
Time frame: 5 years
Diseases Free Survival (DFS)
Time frame: 5 years
Progression Free Survival (PFS)
Time frame: 5 years
Changes in clinical parameter (tumor diameters)
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 27725148Shields CL, Alset AE, Boal NS, Casey MG, Knapp AN, Sugarman JA, Schoen MA, Gordon PS, Douglass AM, Sioufi K, Say EA, Shields JA. Conjunctival Tumors in 5002 Cases. Comparative Analysis of Benign Versus Malignant Counterparts. The 2016 James D. Allen Lecture. Am J Ophthalmol. 2017 Jan;173:106-133. doi: 10.1016/j.ajo.2016.09.034. Epub 2016 Oct 8.
- Background: PubMed 31755426Shields CL, Shields JA. Tumors of the conjunctiva and cornea. Indian J Ophthalmol. 2019 Dec;67(12):1930-1948. doi: 10.4103/ijo.IJO_2040_19.
- Background: PubMed 10923972Esmaeli B, Wang B, Deavers M, Gillenwater A, Goepfert H, Diaz E, Eicher S. Prognostic factors for survival in malignant melanoma of the eyelid skin. Ophthalmic Plast Reconstr Surg. 2000 Jul;16(4):250-7. doi: 10.1097/00002341-200007000-00002.
- Background: PubMed 17020898Soysal HG, Markoc F. Invasive squamous cell carcinoma of the eyelids and periorbital region. Br J Ophthalmol. 2007 Mar;91(3):325-9. doi: 10.1136/bjo.2006.102673. Epub 2006 Oct 4.
- Background: PubMed 15465559Faustina M, Diba R, Ahmadi MA, Esmaeli B. Patterns of regional and distant metastasis in patients with eyelid and periocular squamous cell carcinoma. Ophthalmology. 2004 Oct;111(10):1930-2. doi: 10.1016/j.ophtha.2004.02.009.
- Background: PubMed 11865953Cervantes G, Rodriguez AA Jr, Leal AG. Squamous cell carcinoma of the conjunctiva: clinicopathological features in 287 cases. Can J Ophthalmol. 2002 Feb;37(1):14-9; discussion 19-20. doi: 10.1016/s0008-4182(02)80093-x.
- Background: PubMed 22189448Yousef YA, Finger PT. Squamous carcinoma and dysplasia of the conjunctiva and cornea: an analysis of 101 cases. Ophthalmology. 2012 Feb;119(2):233-40. doi: 10.1016/j.ophtha.2011.08.005. Epub 2011 Dec 20.
- Background: PubMed 11766025Esmaeli B, Eicher S, Popp J, Delpassand E, Prieto VG, Gershenwald JE. Sentinel lymph node biopsy for conjunctival melanoma. Ophthalmic Plast Reconstr Surg. 2001 Nov;17(6):436-42. doi: 10.1097/00002341-200111000-00010.
- Background: PubMed 32698034Freitag SK, Aakalu VK, Tao JP, Wladis EJ, Foster JA, Sobel RK, Yen MT. Sentinel Lymph Node Biopsy for Eyelid and Conjunctival Malignancy: A Report by the American Academy of Ophthalmology. Ophthalmology. 2020 Dec;127(12):1757-1765. doi: 10.1016/j.ophtha.2020.07.031. Epub 2020 Jul 19.
- Background: PubMed 23034693Chak G, Morgan PV, Joseph JM, Tao JP. A positive sentinel lymph node in periocular invasive squamous cell carcinoma: a case series. Ophthalmic Plast Reconstr Surg. 2013 Jan-Feb;29(1):6-10. doi: 10.1097/IOP.0b013e31826a50f7.
- Background: PubMed 22262287Maalouf TJ, Dolivet G, Angioi KS, Leroux A, Genin P, George JL. Sentinel lymph node biopsy in patients with conjunctival and eyelid cancers: experience in 17 patients. Ophthalmic Plast Reconstr Surg. 2012 Jan-Feb;28(1):30-4. doi: 10.1097/IOP.0b013e31822fb44b.
- Background: PubMed 34283293Savino G, Cuffaro G, Maceroni M, Pagliara MM, Sammarco MG, Giraldi L, Blasi MA. Advanced ocular surface squamous cell carcinoma (OSSC): long-term follow-up. Graefes Arch Clin Exp Ophthalmol. 2021 Nov;259(11):3437-3443. doi: 10.1007/s00417-021-05264-3. Epub 2021 Jul 20.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular Sebaceous Carcinoma and Ocular Basal Cell Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gustavo Savino, MD (0630154528, oncologiaoculare@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of lymphoscintigraphic examination and SLN biopsy (time frame: 9 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05797415, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.