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Conjunctival melanoma

 

Conjunctival melanoma: a multicentre study correlating baseline clinical features with histology and genetics

 

 

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Acronym: CONJMEL

 

Principal Investigator:

Professor Sarah E Coupland

Liverpool Ocular Oncology Research Group, Molecular and Clinical Cancer Medicine, University of Liverpool, UK 

 

Chief Investigator:

Professor Bertil Damato

Liverpool Ocular Oncology Centre, Royal Liverpool University Hospital, UK

 

Co-investigators:

1) Dr Sarah Lake, Molecular and Clinical Cancer Medicine, University of Liverpool, UK

2) Dr Nihal Kenawy, MD student, Molecular and Clinical Cancer Medicine, University of Liverpool, UK and Liverpool Ocular Oncology Centre, Royal Liverpool University Hospital, UK

 

This study will collate clinical, histomorphological and genetic data from up to 150 patients with conjunctival melanoma (CoM) or conjunctival intra-epithelial neoplasia (C-MIN) provided by collaborating centres world-wide.

 

The study aims to:

 

1)  Determine the physical location of a CoM or C-MIN.

2)  Use high resolution analysis to detect genetic changes in CoM and C-MIN .

3) Correlate the baseline clinical features, histology and genetics of invasive CoM and C-MIN with outcome. The outcome measures will be local tumour recurrence, regional nodal metastasis, systemic metastasis and survival.

 

Identification of common genetic changes in CoM, C-MIN and correlation with patient outcome will facilitate a better understanding of the molecular pathology of CoM; allowing new drug targets to be identified and robust prognostic biomarkers to be established.

 

Study objectives

 

1) To determine if tumour location is associated with recurrence and metastasis.

2) To determine whether genetic changes correlate with survival or disease recurrence and therefore, if genetic tumour typing may be as useful for prognostication with CoM as it is with uveal melanoma.

3) To further develop proformas and protocols for collating baseline clinical, histological and genetic data from multiple collaborating centres.

 

Target sample size

 

Up to 150 samples of CoM and C-MIN to be collected over a 2-year period.

 

Study plan

 

 Collaborating centres will be asked to:

1) Examine all CoM and C-MIN patients using a standardised protocol and record this information in the proformas provided (please see appended documents).

2) Photograph the conjunctiva, following the standardised procedure that is in routine use in all collaborating centres (i.e., with and without eyelid eversion and with the patient looking in all of the nine cardinal positions of gaze).

3) Measure tumour thickness using high-frequency ultrasonography.

2) Submit a representative formalin–fixed, paraffin-embedded (FFPE) block of the lesion for histology, immunohistochemistry and high resolution genetic analysis (Affymetrix SNP 6.0 microarray).

 

Proformas and photographs will be submitted (by fax and email respectively) to the University of Liverpool Ocular Oncology Research Group (contact person and study coordinator: Dr Nihal Kenawy) at the address given below. All pseudo-anonymised data will be computerised into the study database.

 

Clinical, histological and genetic findings will be correlated with disease recurrence, metastasis and survival over the time-span of the project. Cross-correlation analysis will be first conducted to see if any markers are strongly correlated with each other. Survival analysis will then be carried out using (a) metastases and (b) tumour-specific death as outcome variables. A number of techniques will be investigated including Cox regression, accelerated failure time and artificial neural networks. Mathematical and statistical analysis will be conducted using Matlab, R and SPSS software.

 

Timeline

 

Data collection and genetic analysis will take place in years one and two of the project, in year three data analysis will be performed and the results prepared for peer-reviewed publication and dissemination at an OOG meeting.

 

Ethics

 

Prospective samples will be provided from the collaborating centres following provision of informed consent by patients who wish to take part in the study. All completed proformas and tissue blocks will pseudo-anonymised by being given a unique code. Only the referring physicians from each collaborating centre will be able to link the samples back to the study participant, if necessary, to update clinical information.

 

Ethical approval has been obtained for the UK centres from the local Research Ethics Committee and similar approval will need to be sought by all participating centres from their relevant research ethics board. Copies of approval letters need to be forwarded by fax or email to the study coordinator, Dr Nihal Kenawy, to the address or fax below.

    

Transfer of tissues

 

Before the transfer of any material from a collaborating centre a material transfer agreement (MTA) is to be signed by the institutions sending and receiving the material.

 

Collaborating centres

 

  1. Prof. Sarah Coupland and Prof. Bertil Damato, Liverpool Ocular Oncology Centre and University of Liverpool, UK
  2. Dr Jean Pierre Caujolle, St Roch Hospital, Nice, France
  3. Prof. Laurence Desjardins and Dr Christine Lévy-Gabriel. Institut Curie, Paris, France
  4. Dr Paul T. Finger, The New York Eye Centre, USA
  5. Prof. Tero Kivela, Helsinki University Central Hospital, Finland
  6. Dr Marina Marinkovic, Leiden University Medical Centre, The Netherlands
  7. Prof. Edoardo Midena, Department of Ophthalmology, University of Padova, Italy
  8. Dr Carlo Mosci, Ocular Oncology Service  - Galliera Hospital Genova - Italy
  9. Prof. Jacob Pe’er and Dr Shahar Frenkel, Hadassah Hebrew University Medical Centre, Israel
  10. Prof. Jan U. Prause and Dr Steffen Heregaard, Eye Pathology Institute, Copenhagen, Denmark
  11. Prof. Romanowska-Dixon, Department of Ophthalmology and Ocular Oncology, Jagiellonian University, Kraków, Poland
  12. Dr Ulrich Schaller, Ludwig-Maximillians-Universitat Klinikum Innenstadt, Augenklinik, Munich, Germany
  13. Prof. Murat Tunc, Department of Ophthalmology, Duzce University Medical School, Turkey
  14. Drs Vicktoria Vishnevskia-Dai and Mordechai Rosner, The Goldschleger Eye Institute, Sheba Medical Centre, Tel Aviv University, Israel
  15. Dr Victoria Cohen, St Bart’s and the London Ocular Oncology Service, London, UK
  16. Dr Martine J Jager, Leiden University Medical Centre. The Netherlands
  17. Dr Sonia Callejio, Cedars Cancer Institute, Montreal, Canada
  18. Prof. Lothar Krause, Dessau, Germany
  19. Prof. Frédéric Mouriaux, Service d'Ophtalmologie, CHRU CAEN, France

 

 

For further information about the study please contact:

 

Dr Nihal Kenawy

Liverpool Ocular Oncology Research Group

Molecular and Clinical Cancer Medicine

6th Floor Duncan Building

Daulby Street

Liverpool

L69 3GA

UK

Tel: +44-151-706-4494 mobile: +44 7753663029

Fax: +44-151-706-5883

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