NCT03962088: TiMiSNAR-miRNA

Timisnar - Biomarkers Substudy (Timisnar-mirna)

Recruiting now Last updated 16 April 2024

What this trial tests

trial testing miRNA in Rectal Cancer in 200 participants. Currently enrolling.

Timeline

1 April 2019

Primary endpoint
1 April 2025

1 April 2025

Quick facts

Lead sponsor	Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	200
Start date	1 April 2019
Primary completion	1 April 2025
Estimated completion	1 April 2025
Sites	1 location across Italy

Drugs / interventions tested

• miRNA

Conditions studied

• Rectal Cancer — all drugs for Rectal Cancer →

Sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria — full company profile →

Who can join

18 and older, any sex, with Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Neoadjuvant chemoradiotherapy (nCHT) 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 in the primary tumor and lymph nodes (downstaging). Extensive histopathological work-up of the tumor specimen after surgery including tumor regression grading (TRG) and lymph node status (ypN) helped to visualize individual tumor sensitivity to CRT retrospectively. Since the response to nCHT 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.

As a potential alternative to CEA and ctDNA, microRNAs (miRNAs) are currently under investigation to serve as blood-based biomarkers. miRNAs are small, noncoding RNAs that regulate gene expression by post-transcriptional mRNA binding, which promotes the destabilization of target miRNAs. The target specificity of miRNAs is largely predetermined by their so-called "seed-sequence" (containing nucleotides at position 2-7 of the miRNA). They are highly conserved between species, stable and easy detectable even in small concentrations. They have been widely analyzed in physiological and pathological processes, and their expression is tissue specific.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting non-coding RNAs to overcome cancer therapy resistance.
   Chen B, Dragomir MP, Yang C, Li Q, et al · · 2022 · cited 324× · PMID 35418578 · DOI 10.1038/s41392-022-00975-3
2. microRNA-based diagnostic and therapeutic applications in cancer medicine.
   Sempere LF, Azmi AS, Moore A. · · 2021 · cited 97× · PMID 33998154 · DOI 10.1002/wrna.1662
3. Non-coding RNAs as therapeutic targets in cancer and its clinical application.
   Leng X, Zhang M, Xu Y, Wang J, et al · · 2024 · cited 20× · PMID 39149142 · DOI 10.1016/j.jpha.2024.02.001
4. Recent Technologies towards Diagnostic and Therapeutic Applications of Circulating Nucleic Acids in Colorectal Cancers.
   Chung J, Xiao S, Gao Y, Soung YH. · · 2024 · cited 16× · PMID 39201393 · DOI 10.3390/ijms25168703
5. What Is Known about Theragnostic Strategies in Colorectal Cancer.
   Parisi A, Porzio G, Pulcini F, Cannita K, et al · · 2021 · cited 13× · PMID 33535557 · DOI 10.3390/biomedicines9020140
6. Expression levels of circulating miRNAs as biomarkers during multimodal treatment of rectal cancer - TiMiSNAR-mirna: a substudy of the TiMiSNAR Trial (NCT03962088).
   Monsellato I, Garibaldi E, Cassinotti E, Baldari L, et al · · 2020 · cited 4× · PMID 32711544 · DOI 10.1186/s13063-020-04568-9
7. Lynch Syndrome Biopathology and Treatment: The Potential Role of microRNAs in Clinical Practice.
   Ascrizzi S, Arillotta GM, Grillone K, Caridà G, et al · · 2023 · cited 3× · PMID 37568746 · DOI 10.3390/cancers15153930
8. Exosomal long noncoding RNAs and microRNAs in colorectal cancer.
   Yen Y, Chu TY, Tseng RC. · · 2025 · cited 2× · PMID 40741613 · DOI 10.4103/tcmj.tcmj_62_25