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

A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Responsiveness in Advanced or Metastatic Malignant Melanoma (SYS-ACT)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02177110

Acronym

SYS-ACT

Enrollment

Registered

2014-06-27

Start date

2014-09-30

Completion date

Unknown

Last updated

2020-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Melanoma, Metastatic Melanoma

Keywords

advanced melanoma, metastatic melanoma, fresh frozen tissue, FFPE tissue

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Ireland

Outcome results