SPECTAmel: Screening Patients With Melanoma Tumors for Efficient Clinical Trial Access

NCT ID: NCT02507947

Last Updated: 2018-07-09

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL

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.

Conditions

Melanoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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;

Exclusion Criteria

• 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.

• active hepatitis B/C or HIV
• second malignancies
• severe organ dysfunction or other comorbidities

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline Robert, MD, PhD

Role: STUDY_CHAIR

Gustave Roussy, Cancer Campus, Grand Paris

Other Identifiers

EORTC-1332

Identifier Type: -

Identifier Source: org_study_id