NCT07189312

Brief Summary

MuSTARD is a singular project in the sense that investigators will develop a computational framework that is conceived as a common solution for disparate applications. This framework responds to a common need: the derivation of multi-scale spatio-temporal (ST) models equipped with statistical inference capabilities. Since the sequencing of the human genome, a significant portion of clinical research has shifted to the study of precision medicine (PM), resulting in numerous breakthroughs in both non-communicable and infectious diseases. PM refers to disease treatment and prevention that considers variability in genes, environment, and lifestyle for each person. Main drivers of PM are the omics technologies . Omics data is obtained from new high-throughput instruments that generate massive volumes of data. It is also notoriously complex data to analyze. In the last years, new separation technology has allowed us to measure omics data at single-cell resolution, creating a new (and even more complex) type of data generally referred to as single-cell omics. This allow us to study the spatial distribution of omics in a sample. Spatial and single cell omics represents one of the most powerful approaches today to understand cancer propagation in both time and space. Spatial omics. Unfortunately, there are no computational tools that can readily combine the nature of this new type of data with powerful statistical inference. Furthermore, spatially resolved omics experiments with repeated measures is another form of complex ST data. MuSTARD will provide a new computational framework that can handle ST omics to understand colorectal cancer propagation in both time and space, and leverage it in a new clinical study of reduced sample size (15 patients). The MuSTARD computational framework applied to ST omics will be made available for the general community in the form of open software.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Feb 2025Dec 2026

Study Start

First participant enrolled

February 2, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 23, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2026

Expected
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

September 9, 2025

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • To develop a framework of computational tools and services capable of handling multi-scale spatio-temporal structures in massive scientific data and providing interpretable models and visualizations with sound statistical support.

    Sample Collection A total of 15 patients with a diagnosis of colorectal cancer, that undergoes surgery, will be recruited. Blood and fecal samples will be collected at two time points (baseline and endpoint). In addition, three spatially distinct tissue samples will be obtained at a single time point (during cancer surgery). Measurements * Variation of the intestinal microbiota composition before and after surgery. Intestinal microbiota composition willbe determined by shot-gun sequencing techniques. * Variation of the plasma metabolite before and after surgery, by untargeted metabolimics. * Variation in specific metabolites and gene expression in the colorectal cancer's tissue samples. Next-generation sequencing and untargeted metabolomic techniques will be used. The multi-omics data will be processed and integrated using Artificial Intelligence (AI) techniques, allowing the development

    three years

Study Arms (1)

Patients with a diagnoses of colorectal cancer

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a diagnosis of colorectal cancer that are going to have a cancer planned surgery

You may qualify if:

  • Diagnosis for colorectal cancer
  • Patients with cancer planned surgery
  • Absence of instability microsatellites
  • Absence of any other associated disease that can affect the cancer pathology

You may not qualify if:

  • Patients who need an urgent surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virgen de las Nieves Hospital

Granada, Granada, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fecal, blood and tissue samples

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Jose Camacho, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

September 9, 2025

First Posted

September 23, 2025

Study Start

February 2, 2025

Primary Completion

February 28, 2026

Study Completion (Estimated)

December 2, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations