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Completed

NCT Number: NCT02177110

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

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.

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Key information

Conditions

Advanced Melanoma Melanoma Metastatic Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cork University Hospital, Cork, Ireland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Immunotherapy (for example ipilimumab and/or anti-PD-L1/PD-1 therapies)
  • BRAF and/or MEK inhibitors
  • Patients were FFPE and fresh frozen tissue is available (both mandatory).

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Validation of SYS-ACT

    Time frame: 2 years

    Validate the predictive capacity of SYS-ACT by assessing responsiveness to treatment

  2. 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.

Sponsors and collaborators

Lead sponsor

Cancer Trials Ireland

Network

Registry information

Official study title

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

Acronym: SYS-ACT

Important dates

Study start
2014
Primary completion
2020
First posted
Jun 27, 2014
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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