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

July 6, 2018 updated by: European Organisation for Research and Treatment of Cancer - EORTC
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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pathologically confirmed melanoma of any stage

Description

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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of screened patients
Time Frame: 5 years
5 years
Number of downstream clinical trials;
Time Frame: 5 years
5 years
Number of patients enrolled in the downstream therapeutic trials
Time Frame: 5 years
5 years
Number of exploratory/future research projects
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Caroline Robert, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

January 1, 2030

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

July 23, 2015

First Posted (Estimate)

July 24, 2015

Study Record Updates

Last Update Posted (Actual)

July 9, 2018

Last Update Submitted That Met QC Criteria

July 6, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-1332

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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