SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access

Study Overview
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Brief Summary
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SPECTA is a quality assured platform for collecting clinicopathologically annotated biological material, imaging data, operative images, environmental assessment, questionnaires as well as patient-reported outcomes from cancer patients to support biospecimen-based translational research and clinical cancer research, including biomarker discovery to improve the understanding of tumor biology and cancer patients care.

Detailed Description
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Patients are recruited in the platform for the research purpose of 4 downstream projects. For more information, please have a look at the Groups and cohorts section.

Official Title
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SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access

Conditions
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All Tumor Types

Intervention / Treatment
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* Genetic: RP-1828 IMMUcan
* Genetic: RP-1759 AYA/TYA
* Genetic: RP-1843 Arcagen
* Genetic: RP-1920 BioRadon


Participation Criteria
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Eligibility Criteria
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Patients with pathologically confirmed selected tumor types (at site or centrally); Mandatory availability of adequate human biological material (HBM); Centrally performed confirmation of HBM adequacy in terms of quality and quantity for SPECTA downstream project requirements; Age ≥ 12 years; Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; Written informed consent according to applicable legal and ethical requirements;

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RP-1828 IMMUcan<br>The goal is to generate broad molecular and cellular profiling data of the tumour and its microenvironment from cancer patients integrated with clinical data, to understand how the immune system and tumours interact, and the impact of current therapeutic interventions. Tumor types: Thorax, Head and Neck, Breast, Gastrointestinal, Genito Urinary | Genetic: RP-1828 IMMUcan<br>* WES, lcWGS and RNAseq, multiplex IF and IMC<br>|
| RP-1759 AYA/TYA (CLOSED for recruitment since December 2021)<br>The pilot study will be focusing on young adults (12 to 29 years old) with rare cancer to understand better the biology of the tumor in this specific population, and compare it to children and adults with similar disease, as well as to improve the inclusion of young adults into clinical trials. Tumor type: CNS | Genetic: RP-1759 AYA/TYA<br>* WES, RNAseq and EPIC array<br>|
| RP-1843 Arcagen (CLOSED for recruitment since November 2022)<br>This is a collaborative project between EORTC and EURACAN to perform molecular characterisation of rare cancers patients, using Foundation Medicine tests. The goal of this project is to get a better understanding of the genomic landscape of rare cancers and potentially help define possibilities for targeted treatments/clinical trials for this population. Tumor types: all 10 EURACAN domains | Genetic: RP-1843 Arcagen<br>* NGS panel<br>|
| RP-1920 BioRadon<br>The primary objective is to assess the correlation between the molecular profiles of NSCLC patients and indoor radon concentration, measured with an alpha-particle detector (a standardized and validated way of measuring indoor radon). Tumor type: Thorax | Genetic: RP-1920 BioRadon<br>* NGS panel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish a quality assured platform to improve the understanding of tumor biology and cancer patients care | material (including imaging data) as well as patient-reported outcomes from patients with cancer diagnosis to support biospecimen-based translational research and biomarker discovery to improve the understanding of tumor biology and cancer patients care. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To perform biospecimen and data based high quality research aiming to better understand the biology of cancer, and/or how it is currently managed and/or how to better diagnose and treat it in the future; |  | 5 years | 
| To investigate the molecular pathways related to the development of specific tumors from a biological point of view; |  | 5 years | 
| To investigate the effect of cancer treatment on the tumor, microenvironment and patients globally; |  | 5 years | 
| To collect large series of homogeneous clinical data to analyse the disease course and treatment performed; |  | 5 years | 
| To investigate the prevalence and validate the prognostic or predictive value of novel biomarkers in cancers; |  | 5 years | 
| To perform biospecimen and data based high quality research aiming to facilitate the discovery of new test for tumor biomarkers or facilitate the establishment of validated tests for tumor biomarkers; |  | 5 years | 
| To identify patients with molecular alterations in their tumor that can be matched to biomarker-driven clinical trials, to facilitate enrollment of cancer patients in biomarker-driven clinical trials. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rare cancer, biomarker, molecular screening, cancer, biobanking