|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02177110 |
|
Date of registration:
|
26/06/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma
SYS-ACT |
|
Scientific title:
|
A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Responsiveness in Advanced or Metastatic Malignant Melanoma (SYS-ACT) |
|
Date of first enrolment:
|
September 2014 |
|
Target sample size:
|
16 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02177110 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Ireland
| | | | | | | |
|
Key inclusion & exclusion 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:
-
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Advanced Melanoma
|
|
Metastatic Melanoma
|
|
Primary Outcome(s)
|
|
Validation of SYS-ACT
[Time Frame: 2 years]
|
|
Progression free survival
[Time Frame: 2 years]
|
|
Secondary ID(s)
|
|
ICORG 13-22
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|