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

November 16, 2020 updated by: Cancer Trials Ireland

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Cork, Ireland
        • Cork University Hospital
      • Dublin, Ireland
        • St Vincent's University Hospital
      • Dublin, Ireland
        • Beaumont Hosptial
      • Dublin, Ireland
        • Mater Misericordiae University Hospital and Mater Private Hospital
      • Galway, Ireland
        • Galway University Hospital
      • Waterford, Ireland
        • Waterford Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients must have a diagnosis of advanced or metastatic melanoma of the skin

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of SYS-ACT
Time Frame: 2 years
Validate the predictive capacity of SYS-ACT by assessing responsiveness to treatment
2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Trials Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

June 26, 2014

First Submitted That Met QC Criteria

June 26, 2014

First Posted (Estimate)

June 27, 2014

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICORG 13-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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