Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05934045 |
| Other study ID # |
RC31/22/0507 |
| Secondary ID |
French Ministry |
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2023 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
July 2023 |
| Source |
University Hospital, Toulouse |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The objective of thE project is to determine, whether circRNAs could be used as circulating
prognostic and/or predictive biomarkers of ALK+ ALCL resistance to treatment and whether they
can be exploited as therapeutic targets.
Description:
Anaplastic large-cell lymphoma (ALCL) is an aggressive T-cell pediatric lymphoma. 85% of ALK+
ALCL cases harbor a fusion between the nucleophosmin (NPM) and anaplastic lymphoma kinase
(ALK) genes, leading to a constitutively activated and oncogenic fusion protein. Most ALK+
ALCL cases initially respond well to the frontline chemotherapy, but 30% of patients relapse
and are of poor prognosis. Understanding the origins of therapy resistance is of major
importance to improve treatment and patient prognosis. Current research highlights
deregulated expression of regulatory non-coding RNAs (ncRNAs) as an important factor in
therapy resistance. To date, microRNAs and long noncoding RNAs have been linked to therapy
resistance in ALK+ ALCL. Circular RNAs (circRNAs) are a class of highly stable noncoding RNAs
that have recently come into the focus of researchers. circRNAs can control target gene
expression by e.g. interacting with microRNAs or proteins. This project aims to elucidate
their role in ALK+ ALCL biology including their impact on noncoding RNA networks and therapy
resistance. This project will (1) identify a signature of circRNAs associated with therapy
resistance in ALK+ ALCL, (2) analyze their effect on treatment response, (3) elucidate their
mechanism of action, and (4) evaluate circRNA candidates as predictive and prognostic plasma
biomarkers using liquid biopsies. The goal of the study is to characterize the role of
candidate circRNAs in this well-defined cancer type, which can serve as a model for other
ALK+ cancers. Project results will add to the current mechanistic understanding of ALK+ ALCL
pathogenesis and the origins of therapy resistance, and could define new druggable targets
and associated predictive biomarkers for high-risk disease. Establishing the blood-based
alternative confirmation for the ALK+ ALCL diagnosis could also produce a less invasive
predictive tool capable of longitudinal patient monitoring for early relapse detection.
