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

Metastatic Melanoma Clinical Trial

— SYS-ACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02177110
• Other study ID #: ICORG 13-22
• Status: Completed
• Start date: September 2014

Study information

• Verified date: November 2020
• Source: Cancer Trials Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Advanced Melanoma
• Melanoma
• Metastatic Melanoma

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Trials Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of SYS-ACT	Validate the predictive capacity of SYS-ACT by assessing responsiveness to treatment	2 years
Primary	Progression free survival	Progression free survival (PFS) and overall survival will be assessed for each patient for up to 2 years.	2 years