CADENCE: Project CADENCE (CAncer Detected Early caN be CurEd)
Beobachtungsstudie
Phase nicht angegeben
Biopollis, Helios
Sponsor: MiRXES
Zuletzt aktualisiert: 20. März 2023 Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.
With existing evidence showing the difference in miRNA expression levels between non-cancer and cancer groups, the investigators assume that levels of DNA methylation, RNA expression as well as protein concentration will also be dysregulated during disease progression. Combining the power of multi-omic cancer biomarkers, the investigators hypothesize that the sensitivity and specificity of MiRXES MCST can be significantly improved compared to existing multi-cancer diagnostic tests.
In this study, the investigators propose to develop and validate blood-based, multi-cancer screening tests through a multi-omics approach.
Increased-risk (genetic/familial) cohort Individuals carrying certain germline mutations that predispose the subjects to an increased risk of having cancer than the general population. Subjects will be recruited from Cancer Genetics Service (CGS).
High-risk cohort Individuals diagnosed with diseases that have a high risk of progressing to cancer.
Malignant cohort Individuals diagnosed with cancer. Wherever possible, samples for the 'Malignant group' should have a representation of each cancer stage.
Ausschlusskriterien
Pregnant or lactating (self-declaration), unwilling or unable to provide signed informed consent and has or had received chemotherapy or radiotherapy for cancer treatment and/or any other cancer-related treatment.
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Design-Details
ZuteilungN/A
InterventionsmodellN/A
MaskierungN/A
Anzahl der Teilnehmer15000
Arme & Interventionen
Arme
Interventionen
Typ:
Beschreibung: Individuals representing the general population who self-declare to have no cancer history and have no indications suggestive of underlying cancer development. Subjects will be recruited from a state-of-the-art population study.
Interventionen:
Ergebnismessungen
Primäre Ergebnismessungen
To discover novel intracellular RNA and methylated DNA cancer biomarkers in fresh frozen tumor tissues.through study completion, an average of 2.5 years
To select the best-performing multi-omic single-cancer, biomarker panels for each of the cancer types, and develop the corresponding Single-Cancer Early detection Algorithms (SCEAs).through study completion, an average of 2.5 years
To discover and validate novel cell-free RNA and methylated cell-free DNA cancer biomarkers in the peripheral blood of cancer patients.through study completion, an average of 2.5 years
To develop the best-performing multi-omic multi-cancer biomarker panel by integration and/or optimization of single-cancer panels and develop the corresponding Multi-Cancer Early detection Algorithm (MCEA).through study completion, an average of 2.5 years
To develop in vitro diagnostic assay(s) for the Multi-Cancer Screening Test (MCST) and if appropriate Single-Cancer Screening Tests (SCSTs).through study completion, an average of 2.5 years
To evaluate the clinical performance (AUC, sensitivity, specificity, tissue of origin) of the MCST and if appropriate SCSTs to discriminate cancer cases from control groups.through study completion, an average of 2.5 years
Sekundäre Ergebnismessungen
Secondary outcome: • To explore the relationship between MCST/SCSTs with clinical outcomes based on the collection of longitudinal follow-up information from medical records.through study completion, an average of 2.5 years
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