The Molecular Analyses Project develops a multi-omic signature to predict lymph node involvement in early colorectal cancer — supporting more precise treatment decisions without having to rely on surgery alone.
For patients with early colorectal cancer (T1 CRC), one of the key clinical questions is whether cancer has already spread to nearby lymph nodes. This determines whether surgery is necessary or whether organ-preserving treatment may be sufficient. At present, this risk is estimated mainly using clinical and histological factors, but those alone do not provide precise individual prediction.
The Molecular Analyses Project adds a molecular layer to this decision by integrating genomic, epigenetic, proteomic, and metabolomic data into a single predictive framework.
The project aims to define a multi-modal, multi-omic molecular signature that can predict lymph node metastasis in patients with early colorectal cancer, to be used alongside AI-based staging and standard clinical risk factors.
Combining genomic, epigenetic, proteomic, and metabolomic data into one predictive model rather than relying on any single molecular layer alone.
The signature is designed to identify which T1 CRC patients are likely to have occult lymph node involvement — and which may be safely treated without surgery.
Plasma samples are collected alongside tissue samples, creating the possibility of a minimally invasive blood-based test in the future.
Samples are collected from ETHOS, SCAR, and T-REX participants, creating a prospective and longitudinal multi-centre research resource.
Current histological and clinical factors cannot reliably determine which T1 CRC patients have lymph node spread. This uncertainty leads many patients toward surgery they may not actually need.
A validated molecular signature could support more precise treatment allocation — directing surgery to those who truly need it while helping others avoid overtreatment.
Better individual risk prediction gives clinicians and patients clearer information when deciding between more invasive and more conservative treatment strategies.
If validated, the signature may provide the basis for a future companion diagnostic approach applicable across healthcare systems.
Tumour tissue and plasma samples are collected from ECOPOP trial participants according to standardized procedures.
Genomic, epigenetic, proteomic, and metabolomic analyses are performed on the collected material.
These molecular layers are integrated into a composite predictive model for lymph node metastasis risk.
The signature is intended to be evaluated against longitudinal clinical outcomes from the ECOPOP trial platform.
The Molecular Analyses Project is progressing in a structured sequence, from standardization of procedures to active sample collection and preparation for downstream analyses.
Standard operating procedures for sample collection and processing have been finalized and shared with participating sites, establishing a common framework for sample handling across the project.
Sample collection is ongoing within ECOPOP clinical trials, while preparations for experimental quality control and initial analytical measurements are underway.
The next phase will focus on molecular analyses across the collected material and integration of data layers into a composite signature for lymph node metastasis risk prediction.
The Molecular Analyses Project is one part of ECOPOP’s broader effort to improve treatment decisions in early colorectal cancer through better evidence, better stratification, and better alignment between treatment burden and real patient risk.
Daniel J. Smit
MD PhD · Project lead
d.smit@uke.de
Klaus Pantel
Professor · Project lead
pantel@uke.de
General enquiries
ECOPOP coordination team
ecopop@gumed.edu.pl