Uveal MelanomaMicroGenUMNCT05889481
Morphological, Genetic and Tumour Microenvironment Characterisation in Uveal Melanoma
An observational study of Uveal Melanoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The objectives of the study are the morpho-phenotypic evaluation of uveal melanoma and to identify molecular prognostic factors that may be correlated with disease severity, tumour progression and response to treatment. These objectives will be achieved through immunohistochemical and genetic analyses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- cytogenetic analysis on tumour tissue and Digital Pathology
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2008to May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with uveal melanoma undergoing histological and cytogenetic analysis will be included in the study. The cases will be identified among the patients referred to the Ocular Oncology Unit during the period from January 2008 to December 2019.
Who may be able to join
- Age 18 years or older;
- Clinical and histological diagnosis of uveal melanoma;
- Ability to obtain formalin-fixed, paraffin-embedded tissue (FFPE).
- Availability of genetic analysis results from tumour tissue obtained by enucleation or fine-needle biopsy.
- Follow-up of at least 5 years from enucleation or fine-needle biopsy.
- Written informed consent to use the data for research purposes.
Who cannot join
- Age < 18 years;
- Lack of sufficient clinical data on selected patients.
- Follow-up of less than 5 years.
- Refusal to give informed consent to data processing for research purposes.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Monica Maria Pagliara - Oncologia Oculare
Rome, 00168
Monica Maria Pagliara, MD
About this study
Official title: Morphological, Genetic and Tumour Microenvironment Characterisation in Uveal Melanoma and Impact on the Development of Metastasis and Mortality.
The objectives of the study are the morpho-phenotypic evaluation of uveal melanoma and to identify molecular prognostic factors that may be correlated with disease severity, tumour progression and response to treatment.
These objectives will be achieved through immunohistochemical and genetic analyses.
Read the detailed description
Tissues from surgical specimens regardless of the stage of the disease, fixed in formalin and included in paraffin from samples already collected for clinical practice and kept in the archives of the UOC of Pathological Anatomy of the Fondazione Policlinico Universitario A. Gemelli IRCCS will be used for the study, subject to the patient's informed consent to the use of these samples for research purposes. The UOC Anatomia Patologica will take care of the recovery of archive material (slides).
The pseudoanonymised slides, which will be prepared by clinical practice, will be sent to the Institute of Pathological Histology and Molecular Diagnostics of the Azienda Ospedaliero- Universitaria Careggi, Florence for immunohistochemical analysis, which will be carried out as reported below. Once the following analysis has been performed, the slides will be destroyed.
Sections of 3 μm thickness derived from FFPE samples will be prepared for immunohistochemical analysis. Sample processing will be performed using an automated immunostainer (Ventana Discovery ULTRA, Ventana Medical Systems, Tucson, AZ). Sections will be deparaffinised in EZ prep (#950-102; Ventana Medical Systems, Tucson, AZ), followed by treatment with Cell Conditioning 1 (CC1) buffer (#950-124; Ventana Medical Systems, Tucson, AZ) in order to promote antigenic recovery. Finally, primary antibodies will be dispensed according to the desired staining and the signal will be developed with Ultramap anti-mouse or anti-rabbit detection kits. For TME characterisation, samples will be stained with the following primary antibodies: CD3, CD4, CD8, CD68, CD163. All sections processed with IHC will be digitally scanned in Whole Slide Images (WSI) using the Aperio AT2 platform (Leica Biosystems, Wetzlar, DE).Digital Pathology, which will be performed at the University of Florence, is an emerging discipline that allows the quantitative analysis of digital images using highly standardised approaches. It will allow quantitative measurements of the interactions between immune cells and characterise their relative spatial distribution. In addition, it will be able to generate further information that will allow the TME of the MU to be studied in depth.
The HALO image analysis platform, present at the University of Florence, will allow: i) cell quantification, evaluation of the intensity of the marking, recognition of cell compartments (nucleus, cytoplasm, membrane); ii) spatial analysis through the identification of the relative distributions of cells in the intra- and peri-tumour portion; iii) sharing of the database generated together with the digital images.
Samples labelled with single or multiple IHC will be evaluated using this automated digital quantification system in order to characterise the various cell subsets that make up the TME. By combining multiple immunohistochemistry with digital analysis, the data will be accurately analysed, thus producing a new analysis work-flow for finding new signatures. All data derived from the digital analysis will be correlated with the progression of the pathology, with the aim of identifying new prognostic factors in the pathology of MU.
The analysis for the identification of cytogenetic alterations, whose data are already available to us since they are regularly performed in clinical practice, was conducted on the entire cohort of patients enrolled for the study at the Genetics Institute of the Fondazione Policlinico Gemelli on fresh tissue samples taken in the operating theatre as per clinical practice. Array-CGH methods on oligonucleotide platforms from Agilent Technologies were used. Tumour DNA from MU samples was extracted using the Gentra Pure Gene commercial kit (QIAGEN) as per clinical practice; once extracted, the quantity and purity of the DNA obtained was evaluated. All samples deemed suitable for quality were processed following the protocol indicated by Agilent Technologies. The data obtained were analysed using Cytogenomics software. These analyses will allow a genotypic characterisation of the tumour to be obtained.
- Conditions
- Uveal Melanoma
- Being tested
- cytogenetic analysis on tumour tissue, Digital Pathology
- Keywords
- Uveal melanoma, Digital Pathology, cytogenetic, immunohistochemistry, genotypic characterisation
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytogenetic analysis on tumour tissueGenetic
Array-CGH methods on oligonucleotide platforms from Agilent Technologies were used. Tumour DNA from MU samples was extracted using the Gentra Pure Gene commercial kit (QIAGEN), as per clinical practice. Once extracted, the quantity and purity of the DNA obtained were evaluated. All samples deemed suitable for quality were processed following the protocol indicated by Agilent Technologies. The data obtained were analysed using Cytogenomics software. These analyses will allow a genotypic characterisation of the tumour to be obtained.
Digital PathologyBiological
Digital Pathology is an emerging discipline that enables quantitative analysis of digital images using highly standardised approaches. It will allow quantitative measurements of the interactions between immune cells and characterise their relative spatial distribution. In addition, it will be able to generate further information that will allow in-depth study of the tumour microenvironment of uveal melanoma
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | Patients diagnosed with uveal melanoma undergoing histological and cytogenetic analysis. The cases will be identified from patients referred to the Ocular Oncology Unit and they finished the follow-up Receives: Genetic: cytogenetic analysis on tumour tissue; Biological: Digital Pathology | |
| Prospective cohort | Patients diagnosed with uveal melanoma undergoing histological and cytogenetic analysis. The cases will be identified from patients referred to the Ocular Oncology and they still have to complete the follow-up Receives: Genetic: cytogenetic analysis on tumour tissue; Biological: Digital Pathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
morpho-phenotypic evaluation of uveal melanoma (Digital Pathology - array-CGH)
The primary objective of the study is the morpho-phenotypic evaluation of uveal melanoma.
Measured: 5 years
Secondary outcomes (3)
identify molecular prognostic factors that may correlate with disease severity,
identify molecular prognostic factors that may correlate with disease severity, tumour progression and response to treatment.
Measured: 5 years
Evaluation of overall response rate (ORR)
ORR (in years) at 1,3 and 5 years
Measured: 5 years
Evaluation of progression-free survival (PFS)
PFS (in years) at 1,3 and 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study startJan 2008
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Uveal MelanomaStudies 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
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pagliara Monica Maria, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889481
- Sponsor's protocol ID
- 5703
- Acronym
- MicroGenUM
- Status last verified
- Jun 2023
- First submitted
- 26 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singh AD, Turell ME, Topham AK. Uveal melanoma: trends in incidence, treatment, and survival. Ophthalmology. 2011 Sep;118(9):1881-5. doi: 10.1016/j.ophtha.2011.01.040. Epub 2011 Jun 24.
PubMed 21704381Damato B. Progress in the management of patients with uveal melanoma. The 2012 Ashton Lecture. Eye (Lond). 2012 Sep;26(9):1157-72. doi: 10.1038/eye.2012.126. Epub 2012 Jun 29.
PubMed 22744385Kujala E, Makitie T, Kivela T. Very long-term prognosis of patients with malignant uveal melanoma. Invest Ophthalmol Vis Sci. 2003 Nov;44(11):4651-9. doi: 10.1167/iovs.03-0538.
PubMed 14578381Gill HS, Char DH. Uveal melanoma prognostication: from lesion size and cell type to molecular class. Can J Ophthalmol. 2012 Jun;47(3):246-53. doi: 10.1016/j.jcjo.2012.03.038.
PubMed 22687301Van Raamsdonk CD, Bezrookove V, Green G, Bauer J, Gaugler L, O'Brien JM, Simpson EM, Barsh GS, Bastian BC. Frequent somatic mutations of GNAQ in uveal melanoma and blue naevi. Nature. 2009 Jan 29;457(7229):599-602. doi: 10.1038/nature07586. Epub 2008 Dec 10.
PubMed 19078957Robertson AG, Shih J, Yau C, Gibb EA, Oba J, Mungall KL, Hess JM, Uzunangelov V, Walter V, Danilova L, Lichtenberg TM, Kucherlapati M, Kimes PK, Tang M, Penson A, Babur O, Akbani R, Bristow CA, Hoadley KA, Iype L, Chang MT; TCGA Research Network; Cherniack AD, Benz C, Mills GB, Verhaak RGW, Griewank KG, Felau I, Zenklusen JC, Gershenwald JE, Schoenfield L, Lazar AJ, Abdel-Rahman MH, Roman-Roman S, Stern MH, Cebulla CM, Williams MD, Jager MJ, Coupland SE, Esmaeli B, Kandoth C, Woodman SE. Integrative Analysis Identifies Four Molecular and Clinical Subsets in Uveal Melanoma. Cancer Cell. 2017 Aug 14;32(2):204-220.e15. doi: 10.1016/j.ccell.2017.07.003.
PubMed 28810145Jager MJ, Shields CL, Cebulla CM, Abdel-Rahman MH, Grossniklaus HE, Stern MH, Carvajal RD, Belfort RN, Jia R, Shields JA, Damato BE. Uveal melanoma. Nat Rev Dis Primers. 2020 Apr 9;6(1):24. doi: 10.1038/s41572-020-0158-0.
PubMed 32273508Seedor RS, Orloff M, Sato T. Genetic Landscape and Emerging Therapies in Uveal Melanoma. Cancers (Basel). 2021 Nov 2;13(21):5503. doi: 10.3390/cancers13215503.
PubMed 34771666Triozzi PL, Schoenfield L, Plesec T, Saunthararajah Y, Tubbs RR, Singh AD. Molecular profiling of primary uveal melanomas with tumor-infiltrating lymphocytes. Oncoimmunology. 2014 Oct 31;8(10):e947169. doi: 10.4161/21624011.2014.947169. eCollection 2019.
PubMed 31646061Maat W, Ly LV, Jordanova ES, de Wolff-Rouendaal D, Schalij-Delfos NE, Jager MJ. Monosomy of chromosome 3 and an inflammatory phenotype occur together in uveal melanoma. Invest Ophthalmol Vis Sci. 2008 Feb;49(2):505-10. doi: 10.1167/iovs.07-0786.
PubMed 18234992Kaler CJ, Dollar JJ, Cruz AM, Kuznetsoff JN, Sanchez MI, Decatur CL, Licht JD, Smalley KSM, Correa ZM, Kurtenbach S, Harbour JW. BAP1 Loss Promotes Suppressive Tumor Immune Microenvironment via Upregulation of PROS1 in Class 2 Uveal Melanomas. Cancers (Basel). 2022 Jul 28;14(15):3678. doi: 10.3390/cancers14153678.
PubMed 35954340Bronkhorst IH, Jager MJ. Inflammation in uveal melanoma. Eye (Lond). 2013 Feb;27(2):217-23. doi: 10.1038/eye.2012.253. Epub 2012 Dec 14.
PubMed 23238448van Smeden M, Moons KG, de Groot JA, Collins GS, Altman DG, Eijkemans MJ, Reitsma JB. Sample size for binary logistic prediction models: Beyond events per variable criteria. Stat Methods Med Res. 2019 Aug;28(8):2455-2474. doi: 10.1177/0962280218784726. Epub 2018 Jul 3.
PubMed 29966490Moons KG, Altman DG, Reitsma JB, Ioannidis JP, Macaskill P, Steyerberg EW, Vickers AJ, Ransohoff DF, Collins GS. Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD): explanation and elaboration. Ann Intern Med. 2015 Jan 6;162(1):W1-73. doi: 10.7326/M14-0698.
PubMed 25560730
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological, Genetic and Tumour Microenvironment Characterisation in Uveal Melanoma and Impact on the Development of Metastasis and Mortality.
- ClinicalTrials.gov ID
- NCT05889481
- Acronym / sponsor ID
- MicroGenUM / 5703
- Conditions
- Uveal Melanoma
- Keywords
- Uveal melanoma, Digital Pathology, cytogenetic, immunohistochemistry, genotypic characterisation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Jan 2008 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 5 Jun 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 objectives of the study are the morpho-phenotypic evaluation of uveal melanoma and to identify molecular prognostic factors that may be correlated with disease severity, tumour progression and response to treatment.
These objectives will be achieved through immunohistochemical and genetic analyses.
Detailed description
Tissues from surgical specimens regardless of the stage of the disease, fixed in formalin and included in paraffin from samples already collected for clinical practice and kept in the archives of the UOC of Pathological Anatomy of the Fondazione Policlinico Universitario A. Gemelli IRCCS will be used for the study, subject to the patient's informed consent to the use of these samples for research purposes. The UOC Anatomia Patologica will take care of the recovery of archive material (slides).
The pseudoanonymised slides, which will be prepared by clinical practice, will be sent to the Institute of Pathological Histology and Molecular Diagnostics of the Azienda Ospedaliero- Universitaria Careggi, Florence for immunohistochemical analysis, which will be carried out as reported below. Once the following analysis has been performed, the slides will be destroyed.
Sections of 3 μm thickness derived from FFPE samples will be prepared for immunohistochemical analysis. Sample processing will be performed using an automated immunostainer (Ventana Discovery ULTRA, Ventana Medical Systems, Tucson, AZ). Sections will be deparaffinised in EZ prep (#950-102; Ventana Medical Systems, Tucson, AZ), followed by treatment with Cell Conditioning 1 (CC1) buffer (#950-124; Ventana Medical Systems, Tucson, AZ) in order to promote antigenic recovery. Finally, primary antibodies will be dispensed according to the desired staining and the signal will be developed with Ultramap anti-mouse or anti-rabbit detection kits. For TME characterisation, samples will be stained with the following primary antibodies: CD3, CD4, CD8, CD68, CD163. All sections processed with IHC will be digitally scanned in Whole Slide Images (WSI) using the Aperio AT2 platform (Leica Biosystems, Wetzlar, DE).Digital Pathology, which will be performed at the University of Florence, is an emerging discipline that allows the quantitative analysis of digital images using highly standardised approaches. It will allow quantitative measurements of the interactions between immune cells and characterise their relative spatial distribution. In addition, it will be able to generate further information that will allow the TME of the MU to be studied in depth.
The HALO image analysis platform, present at the University of Florence, will allow: i) cell quantification, evaluation of the intensity of the marking, recognition of cell compartments (nucleus, cytoplasm, membrane); ii) spatial analysis through the identification of the relative distributions of cells in the intra- and peri-tumour portion; iii) sharing of the database generated together with the digital images.
Samples labelled with single or multiple IHC will be evaluated using this automated digital quantification system in order to characterise the various cell subsets that make up the TME. By combining multiple immunohistochemistry with digital analysis, the data will be accurately analysed, thus producing a new analysis work-flow for finding new signatures. All data derived from the digital analysis will be correlated with the progression of the pathology, with the aim of identifying new prognostic factors in the pathology of MU.
The analysis for the identification of cytogenetic alterations, whose data are already available to us since they are regularly performed in clinical practice, was conducted on the entire cohort of patients enrolled for the study at the Genetics Institute of the Fondazione Policlinico Gemelli on fresh tissue samples taken in the operating theatre as per clinical practice. Array-CGH methods on oligonucleotide platforms from Agilent Technologies were used. Tumour DNA from MU samples was extracted using the Gentra Pure Gene commercial kit (QIAGEN) as per clinical practice; once extracted, the quantity and purity of the DNA obtained was evaluated. All samples deemed suitable for quality were processed following the protocol indicated by Agilent Technologies. The data obtained were analysed using Cytogenomics software. These analyses will allow a genotypic characterisation of the tumour to be obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | Genetic: cytogenetic analysis on tumour tissue, Biological: Digital PathologyPatients diagnosed with uveal melanoma undergoing histological and cytogenetic analysis. The cases will be identified from patients referred to the Ocular Oncology Unit and they finished the follow-up |
| Prospective cohort | – | Genetic: cytogenetic analysis on tumour tissue, Biological: Digital PathologyPatients diagnosed with uveal melanoma undergoing histological and cytogenetic analysis. The cases will be identified from patients referred to the Ocular Oncology and they still have to complete the follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with uveal melanoma undergoing histological and cytogenetic analysis will be included in the study. The cases will be identified among the patients referred to the Ocular Oncology Unit during the period from January 2008 to December 2019.
Key inclusion criteria (6 listed)
- Age 18 years or older;
- Clinical and histological diagnosis of uveal melanoma;
- Ability to obtain formalin-fixed, paraffin-embedded tissue (FFPE).
- Availability of genetic analysis results from tumour tissue obtained by enucleation or fine-needle biopsy.
- Follow-up of at least 5 years from enucleation or fine-needle biopsy.
Key exclusion criteria (4 listed)
- Age < 18 years;
- Lack of sufficient clinical data on selected patients.
- Follow-up of less than 5 years.
- Refusal to give informed consent to data processing for research purposes.
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 |
|---|---|---|
| cytogenetic analysis on tumour tissueArray-CGH methods on oligonucleotide platforms from Agilent Technologies were used. Tumour DNA from MU samples was extracted using the Gentra Pure Gene commercial kit (QIAGEN), as per clinical practice. Once extracted, the quantity and purity of the DNA obtained were evaluated. All samples deemed suitable for quality were processed following the protocol indicated by Agilent Technologies. The data obtained were analysed using Cytogenomics software. These analyses will allow a genotypic characterisation of the tumour to be obtained. | Genetic | Prospective cohort, Retrospective cohort |
| Digital PathologyDigital Pathology is an emerging discipline that enables quantitative analysis of digital images using highly standardised approaches. It will allow quantitative measurements of the interactions between immune cells and characterise their relative spatial distribution. In addition, it will be able to generate further information that will allow in-depth study of the tumour microenvironment of uveal melanoma | Biological | Prospective cohort, Retrospective cohort |
Primary outcome
morpho-phenotypic evaluation of uveal melanoma (Digital Pathology - array-CGH)
Time frame: 5 years
The primary objective of the study is the morpho-phenotypic evaluation of uveal melanoma.
3 secondary outcomes
identify molecular prognostic factors that may correlate with disease severity,
Time frame: 5 years
Evaluation of overall response rate (ORR)
Time frame: 5 years
Evaluation of progression-free survival (PFS)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Background: PubMed 21704381Singh AD, Turell ME, Topham AK. Uveal melanoma: trends in incidence, treatment, and survival. Ophthalmology. 2011 Sep;118(9):1881-5. doi: 10.1016/j.ophtha.2011.01.040. Epub 2011 Jun 24.
- Background: PubMed 22744385Damato B. Progress in the management of patients with uveal melanoma. The 2012 Ashton Lecture. Eye (Lond). 2012 Sep;26(9):1157-72. doi: 10.1038/eye.2012.126. Epub 2012 Jun 29.
- Background: PubMed 14578381Kujala E, Makitie T, Kivela T. Very long-term prognosis of patients with malignant uveal melanoma. Invest Ophthalmol Vis Sci. 2003 Nov;44(11):4651-9. doi: 10.1167/iovs.03-0538.
- Background: PubMed 22687301Gill HS, Char DH. Uveal melanoma prognostication: from lesion size and cell type to molecular class. Can J Ophthalmol. 2012 Jun;47(3):246-53. doi: 10.1016/j.jcjo.2012.03.038.
- Background: PubMed 19078957Van Raamsdonk CD, Bezrookove V, Green G, Bauer J, Gaugler L, O'Brien JM, Simpson EM, Barsh GS, Bastian BC. Frequent somatic mutations of GNAQ in uveal melanoma and blue naevi. Nature. 2009 Jan 29;457(7229):599-602. doi: 10.1038/nature07586. Epub 2008 Dec 10.
- Background: PubMed 28810145Robertson AG, Shih J, Yau C, Gibb EA, Oba J, Mungall KL, Hess JM, Uzunangelov V, Walter V, Danilova L, Lichtenberg TM, Kucherlapati M, Kimes PK, Tang M, Penson A, Babur O, Akbani R, Bristow CA, Hoadley KA, Iype L, Chang MT; TCGA Research Network; Cherniack AD, Benz C, Mills GB, Verhaak RGW, Griewank KG, Felau I, Zenklusen JC, Gershenwald JE, Schoenfield L, Lazar AJ, Abdel-Rahman MH, Roman-Roman S, Stern MH, Cebulla CM, Williams MD, Jager MJ, Coupland SE, Esmaeli B, Kandoth C, Woodman SE. Integrative Analysis Identifies Four Molecular and Clinical Subsets in Uveal Melanoma. Cancer Cell. 2017 Aug 14;32(2):204-220.e15. doi: 10.1016/j.ccell.2017.07.003.
- Background: PubMed 32273508Jager MJ, Shields CL, Cebulla CM, Abdel-Rahman MH, Grossniklaus HE, Stern MH, Carvajal RD, Belfort RN, Jia R, Shields JA, Damato BE. Uveal melanoma. Nat Rev Dis Primers. 2020 Apr 9;6(1):24. doi: 10.1038/s41572-020-0158-0.
- Background: PubMed 34771666Seedor RS, Orloff M, Sato T. Genetic Landscape and Emerging Therapies in Uveal Melanoma. Cancers (Basel). 2021 Nov 2;13(21):5503. doi: 10.3390/cancers13215503.
- Background: PubMed 31646061Triozzi PL, Schoenfield L, Plesec T, Saunthararajah Y, Tubbs RR, Singh AD. Molecular profiling of primary uveal melanomas with tumor-infiltrating lymphocytes. Oncoimmunology. 2014 Oct 31;8(10):e947169. doi: 10.4161/21624011.2014.947169. eCollection 2019.
- Background: PubMed 18234992Maat W, Ly LV, Jordanova ES, de Wolff-Rouendaal D, Schalij-Delfos NE, Jager MJ. Monosomy of chromosome 3 and an inflammatory phenotype occur together in uveal melanoma. Invest Ophthalmol Vis Sci. 2008 Feb;49(2):505-10. doi: 10.1167/iovs.07-0786.
- Background: PubMed 35954340Kaler CJ, Dollar JJ, Cruz AM, Kuznetsoff JN, Sanchez MI, Decatur CL, Licht JD, Smalley KSM, Correa ZM, Kurtenbach S, Harbour JW. BAP1 Loss Promotes Suppressive Tumor Immune Microenvironment via Upregulation of PROS1 in Class 2 Uveal Melanomas. Cancers (Basel). 2022 Jul 28;14(15):3678. doi: 10.3390/cancers14153678.
- Background: PubMed 23238448Bronkhorst IH, Jager MJ. Inflammation in uveal melanoma. Eye (Lond). 2013 Feb;27(2):217-23. doi: 10.1038/eye.2012.253. Epub 2012 Dec 14.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Uveal Melanoma, 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 6 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monica Maria Pagliara, MD,PhD (0630154528, oncologiaoculare@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morpho-phenotypic evaluation of uveal melanoma (Digital Pathology - array-CGH) (time frame: 5 years). 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 NCT05889481, which also lists 14 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 18 Jun 2023.