Deciphering the Role of Circular RNAs in ALKpositive Anaplastic Large-cell Lymphoma (CIRComa)
July 3, 2023 updated by: University Hospital, Toulouse
Deciphering the Role of Circular RNAs in the Pathogenesis and Therapy Resistance of ALKpositive Anaplastic Large-cell Lymphoma
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Toulouse, France, 31500
- IUCT-Oncopole University Hospital
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patient at diagnosis of ALK+ ALCL, patient at the time of relapse for ALK+ ALCL, patient without ALK+ ALCL
Description
Inclusion Criteria:
- patient at diagnosis of ALK+ ALCL
- patient at the time of relapse for ALK+ ALCL
- patient without ALK+ ALCL
Exclusion Criteria:
-
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ALCL patient samples (serum)
serum collected at diagnosis, during treatment and/or at relapse
|
there is no intervention done.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with relapse and circulating circRNA
Time Frame: 1 year after the end of treatment
|
RNAseq analysis
|
1 year after the end of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laurence Lamant, University Hospital, Toulouse
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
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
June 1, 2023
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
June 23, 2023
First Submitted That Met QC Criteria
July 3, 2023
First Posted (Actual)
July 6, 2023
Study Record Updates
Last Update Posted (Actual)
July 6, 2023
Last Update Submitted That Met QC Criteria
July 3, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/22/0507
- French Ministry of Health (Other Grant/Funding Number: PRT-K22-051)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.