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

NCT02507947 | Withdrawn

• 1 other identifier: EORTC-1332
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pathologically confirmed melanoma of any stage

You may qualify if:

• 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)
• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Biospecimen

Retention: SAMPLES WITH DNA

FFPE block of tumor tissue, blood samples

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Caroline Robert, MD, PhD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: July 24, 2015
• Primary Completion (Estimated): January 1, 2030
• Last Updated: July 9, 2018

Record last verified: 2018-07