A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Responsiveness in Advanced or Metastatic Malignant Melanoma (SYS-ACT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Advanced Melanoma
- Sponsor
- Cancer Trials Ireland
- Enrollment
- 16
- Locations
- 6
- Primary Endpoint
- Validation of SYS-ACT
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients ≥ 18 years of age.
- •Patient must be able to give own signed informed consent.
- •Patients that present with advanced or metastatic (stage III/IV) malignant melanoma of the skin.
- •Patients that are planned to receive either:
- •Adjuvant treatment
- •1st line treatment for metastatic disease
- •2nd line treatment for metastatic disease
- •Patients with prior adjuvant treatment are allowed.
- •Patients receiving planned standard treatment of one or more of the following:
- •Chemotherapy regimens containing DTIC, TMZ and/or cisplatin
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Validation of SYS-ACT
Time Frame: 2 years
Validate the predictive capacity of SYS-ACT by assessing responsiveness to treatment
Progression free survival
Time Frame: 2 years
Progression free survival (PFS) and overall survival will be assessed for each patient for up to 2 years.