A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma (SYS-ACT)
A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Responsiveness in Advanced or Metastatic Malignant Melanoma (SYS-ACT)
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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Cork, Irland
- Cork University Hospital
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Dublin, Irland
- St Vincent's University Hospital
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Dublin, Irland
- Beaumont Hosptial
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Dublin, Irland
- Mater Misericordiae University Hospital and Mater Private Hospital
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Galway, Irland
- Galway University Hospital
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Waterford, Irland
- Waterford Regional Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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:
-
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Study
Patients who have fresh frozen and FFPE tissue taken prior to treatment
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Control
Fresh frozen tissue and FFPE tissue is available
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Validation of SYS-ACT
Tidsram: 2 years
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Validate the predictive capacity of SYS-ACT by assessing responsiveness to treatment
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2 years
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Progression free survival
Tidsram: 2 years
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Progression free survival (PFS) and overall survival will be assessed for each patient for up to 2 years.
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2 years
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ICORG 13-22
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