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

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ClinicalTrials.gov Identifier: NCT02177110
Recruitment Status : Active, not recruiting
First Posted : June 27, 2014
Last Update Posted : October 11, 2018
Sponsor:
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

Study Type : Observational
Estimated Enrollment : 80 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 : September 27, 2018
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Group/Cohort
Study
Patients who have fresh frozen and FFPE tissue taken prior to treatment
Control
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02177110


Locations
Ireland
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

Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT02177110     History of Changes
Other Study ID Numbers: ICORG 13-22
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Keywords provided by Cancer Trials Ireland:
advanced melanoma
metastatic melanoma
fresh frozen tissue
FFPE tissue

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas