A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma

Completed

• Conditions: Advanced Melanoma; Metastatic Melanoma

• Registration Number: NCT02177110
• Lead Sponsor: Cancer Trials Ireland

Brief Summary

This is an exploratory prospective translational multicentre study. Melanoma is the 5th most common cancer diagnosed in Ireland and its incidence among women and men is above the European average.

Following treatment the elimination of cancer cells ultimately occurs by the activation of apoptotic cell death pathways. The SYS-ACT approach builds on a combination of mathematical systems of modelling, quantitative biochemistry and cell biology, and specifically predicts the drug responsiveness of melanoma cell lines to various apoptosis-inducing treatments.

The investigators propose to validate the SYS-ACT approach and application in a translational systems medicine study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-06-26
• Study First Posted: 2014-06-27
• Study Start: 2014-09
• Primary Completion: 2020-08
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Patients ≥ 18 years of age.

2. Patient must be able to give own signed informed consent.

3. Patients that present with advanced or metastatic (stage III/IV) malignant melanoma of the skin.

4. Patients that are planned to receive either:

   • Adjuvant treatment
   • 1st line treatment for metastatic disease
   • 2nd line treatment for metastatic disease

5. Patients with prior adjuvant treatment are allowed.

6. Patients receiving planned standard treatment of one or more of the following:

   • Chemotherapy regimens containing DTIC, TMZ and/or cisplatin
   • Immunotherapy (for example ipilimumab and/or anti-PD-L1/PD-1 therapies)
   • BRAF and/or MEK inhibitors

7. Patients were FFPE and fresh frozen tissue is available (both mandatory).

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of SYS-ACT	2 years	Validate the predictive capacity of SYS-ACT by assessing responsiveness to treatment
Progression free survival	2 years	Progression free survival (PFS) and overall survival will be assessed for each patient for up to 2 years.

Trial Locations

Locations (6)

Cork University Hospital; 🇮🇪 Cork, Ireland

Beaumont Hosptial; 🇮🇪 Dublin, Ireland

Mater Misericordiae University Hospital and Mater Private Hospital; 🇮🇪 Dublin, Ireland

St Vincent's University Hospital; 🇮🇪 Dublin, Ireland

Galway University Hospital; 🇮🇪 Galway, Ireland

Waterford Regional Hospital; 🇮🇪 Waterford, Ireland