Advanced MelanomaSYS-ACTNCT02177110
A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma
An observational study of Advanced Melanoma and Metastatic Melanoma, run by Cancer Trials Ireland at 6 sites in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Melanoma, Metastatic Melanoma
- How many people
- 16 participants
- Where
- 6 sitesIreland
- Study dates
- Sep 2014to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients must have a diagnosis of advanced or metastatic melanoma of the skin
Who may be able to join
- 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
Show all 13Show fewer
- 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).
Who cannot join
- -
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Ireland6 sites
Cork University Hospital
Cork
Beaumont Hosptial
Dublin
Mater Misericordiae University Hospital and Mater Private Hospital
Dublin
St Vincent's University Hospital
Dublin
Galway University Hospital
Galway
Waterford Regional Hospital
Waterford
About this study
Official title: 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.
- Conditions
- Advanced Melanoma, Metastatic Melanoma
- Keywords
- advanced melanoma, metastatic melanoma, fresh frozen tissue, FFPE tissue
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study | Patients who have fresh frozen and FFPE tissue taken prior to treatment | |
| Control | Fresh frozen tissue and FFPE tissue is available |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of SYS-ACT
Validate the predictive capacity of SYS-ACT by assessing responsiveness to treatment
Measured: 2 years
Progression free survival
Progression free survival (PFS) and overall survival will be assessed for each patient for up to 2 years.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177110
- Sponsor's protocol ID
- ICORG 13-22
- Acronym
- SYS-ACT
- Status last verified
- Nov 2020
- First submitted
- 26 Jun 2014
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Responsiveness in Advanced or Metastatic Malignant Melanoma (SYS-ACT)
- ClinicalTrials.gov ID
- NCT02177110
- Acronym / sponsor ID
- SYS-ACT / ICORG 13-22
- Conditions
- Advanced Melanoma, Metastatic Melanoma
- Keywords
- advanced melanoma, metastatic melanoma, fresh frozen tissue, FFPE tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Sep 2014 (actual)
- Primary completion
- Aug 2020 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | – | –Patients who have fresh frozen and FFPE tissue taken prior to treatment |
| Control | – | –Fresh frozen tissue and FFPE tissue is available |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients must have a diagnosis of advanced or metastatic melanoma of the skin
Key inclusion criteria (13 listed)
- 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:
- Patients with prior adjuvant treatment are allowed.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of SYS-ACT
Time frame: 2 years
Validate the predictive capacity of SYS-ACT by assessing responsiveness to treatment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Melanoma and Metastatic Melanoma, run by Cancer Trials Ireland at 6 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of SYS-ACT (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.