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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02177110
Recruitment Status : Completed
First Posted : June 27, 2014
Last Update Posted : November 17, 2020
Information provided by (Responsible Party):
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.

Condition or disease
Advanced Melanoma Metastatic Melanoma

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Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Responsiveness in Advanced or Metastatic Malignant Melanoma (SYS-ACT)
Actual Study Start Date : September 2014
Actual Primary Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Patients who have fresh frozen and FFPE tissue taken prior to treatment
Fresh frozen tissue and FFPE tissue is available

Primary Outcome Measures :
  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.

Biospecimen Retention:   Samples With DNA
Fresh frozen and FFPE tissue samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients must have a diagnosis of advanced or metastatic melanoma of the skin

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02177110

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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
Sponsors and Collaborators
Cancer Trials Ireland
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Responsible Party: Cancer Trials Ireland Identifier: NCT02177110    
Other Study ID Numbers: ICORG 13-22
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Keywords provided by Cancer Trials Ireland:
advanced melanoma
metastatic melanoma
fresh frozen tissue
FFPE tissue
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas