Melanoma
Conditions
Brief summary
SPECTAmel is a standardized, quality-assured molecular screening platform for tumor characterization and storage of human biological material (HBM) for the purpose of integrating new biomarkers into clinical trials and optimizing access of patients to therapeutic biomarker-driven clinical trials. HBM and clinical/pathological data are collected from consenting patients.
Interventions
None listed
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed melanoma of any stage (the steering committee will decide on which stage to include at any particular time point during this trial, this will be communicated appropriately to all participating sites) * Mandatory availability of adequate human biological material (HBM): FFPE tissue sample from the primary tumor, recurrent tumor, metastasis, obtained at the time of primary surgery/biopsy; minimal amount requested is detailed in the HBM guidelines; if feasible, inclusion of samples taken at any recurrence diagnosed during follow-up is strongly encouraged but optional; * Age ≥ 18 years; * At least three months life-expectancy; * Written informed consent according to ICH/GCP and national/local regulations; * Absence of any active malignancy, except pT1-2 prostatic cancer Gleason score \< 6, or carcinoma in situ of the cervix, in the 5 years before study entry; * Absence of
Exclusion criteria
like active hepatitis B/C or HIV, second malignancies, no severe organ dysfunction or other comorbidities that may prevent inclusion into clinical trials. * Central confirmation of human biological material (HBM) adequacy for step 2: * Centrally performed confirmation of tumor tissue adequacy in terms of quality/ quantity for central screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of screened patients | 5 years |
| Number of downstream clinical trials; | 5 years |
| Number of patients enrolled in the downstream therapeutic trials | 5 years |
| Number of exploratory/future research projects | 5 years |
Outcome results
None listed