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Expression levels of circulating miRNAs as biomarkers during multimodal treatment of rectal cancer - TiMiSNAR-mirna: a substudy of the TiMiSNAR Trial (NCT03962088).
- Source :
-
Trials [Trials] 2020 Jul 25; Vol. 21 (1), pp. 678. Date of Electronic Publication: 2020 Jul 25. - Publication Year :
- 2020
-
Abstract
- Background: Neoadjuvant chemoradiotherapy followed by surgery is the mainstay treatment for locally advanced rectal cancer, leading to significant decrease in tumor size (downsizing) and a shift towards earlier disease stage (downstaging). Extensive histopathological work-up of the tumor specimen after surgery including tumor regression grading and lymph node status helped to visualize individual tumor sensitivity to chemoradiotherapy, retrospectively. As the response to neoadjuvant chemoradiotherapy is heterogeneous, however, valid biomarkers are needed to monitor tumor response. A relevant number of studies aimed to identify molecular markers retrieved from tumor tissue while the relevance of blood-based biomarkers is less stringent assessed. MicroRNAs are currently under investigation to serve as blood-based biomarkers. To date, no screening approach to identify relevant miRNAs as biomarkers in blood of patients with rectal cancer was undertaken. The aim of the study is to investigate the role of circulating miRNAs as biomarkers in those patients included in the TiMiSNAR Trial (NCT03465982). This is a biomolecular substudy of TiMiSNAR Trial (NCT03962088).<br />Methods: All included patients in the TiMiSNAR Trial are supposed to undergo blood collection at the time of diagnosis, after neoadjuvant treatment, after 1 month from surgery, and after adjuvant chemotherapy whenever indicated.<br />Discussion: TiMiSNAR-MIRNA will evaluate the association of variation between preneoadjuvant and postneoadjuvant expression levels of miRNA with pathological complete response. Moreover, the study will evaluate the role of liquid biopsies in the monitoring of treatment, correlate changes in expression levels of miRNA following complete surgical resection with disease-free survival, and evaluate the relation between changes in miRNA during surveillance and tumor relapse.<br />Trial Registration: Clinicaltrials.gov NCT03962088 . Registered on 23 May 2019.
- Subjects :
- Biomarkers blood
Chemoradiotherapy
Combined Modality Therapy
Disease-Free Survival
Humans
Neoadjuvant Therapy
Neoplasm Staging
Observational Studies as Topic
Randomized Controlled Trials as Topic
Retrospective Studies
Treatment Outcome
MicroRNAs blood
Rectal Neoplasms blood
Rectal Neoplasms therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1745-6215
- Volume :
- 21
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 32711544
- Full Text :
- https://doi.org/10.1186/s13063-020-04568-9