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Blood biomarkers could replace invasive biopsies for colorectal cancer monitoring

NCT ID NCT07754513

Diagnosis Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This study investigates whether tiny particles shed by tumors into the blood, called extracellular vesicles, can serve as a non-invasive biomarker for metastatic colorectal cancer. Researchers will analyze blood samples from 290 patients at different treatment stages to see if these vesicles' RNA and protein signatures can predict treatment response and monitor disease progression. The goal is to develop a simple blood test that could guide personalized treatment decisions without the need for repeated tissue biopsies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Blood sample collection for extracellular vesicle biomarker analysis
What this could lead to
If successful, this could lead to a simple blood test to monitor colorectal cancer progression and personalize treatment without invasive biopsies.
What could go wrong
This is an observational study, so it won't directly test a treatment. The biomarkers may not prove reliable enough for clinical use, and results may not generalize beyond the specific patient group studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 290 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The retrospective cohort will include a total of 160 patients with metastatic colorectal cancer (mCRC) who have already received first-line systemic therapy (chemotherapy with or without biological agents), for whom biological samples and clinical data collected as part of routine clinical practice are available. Biological sample collection is planned for the period from 2017 to 2025. The prospective cohort will include 130 treatment-naïve patients with mCRC, who will be enrolled at the initiation of first-line therapy.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Retrospective Cohort Inclusion Criteria: * Age ≥ 18 years; * Histologically confirmed diagnosis of colorectal adenocarcinoma; * Radiological evidence of metastatic or locally advanced unresectable disease; * First-line treatment for metastatic disease already completed or ongoing according to standard clinical practice; * Availability of stored biological samples collected at least at one of the protocol-defined time points (baseline, post-treatment, disease progression); * Informed consent acquisition will be performed in accordance with Article 110-bis of the Italian Privacy Code. Retrospective Cohort Exclusion Criteria: * Absence of suitable biological samples or samples unsuitable for molecular analyses; * Incomplete clinical data preventing the performance of the planned analyses; * Insufficient quality of stored biological samples for the assessment of EV-RNA and EV-PROT analyses. Prospective Cohort Inclusion Criteria: * Age ≥ 18 years; * Histologically confirmed diagnosis of colorectal adenocarcinoma; * Radiological evidence of unresectable metastatic disease; * Patients not previously treated for metastatic disease (prior completed adjuvant/neoadjuvant therapy is allowed if completed ≥ 6 months before study enrollment); * Indication for first-line treatment with chemotherapy ± biological therapy according to standard clinical practice; * Ability to understand the study procedures and provide written informed consent. Prospective Cohort Exclusion Criteria: * Previous systemic treatment for metastatic disease (except prior adjuvant/neoadjuvant therapy as specified above); * Ongoing pregnancy or breastfeeding; * Legal incapacity or limitation in the ability to provide informed consent.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic colorectal cancer

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.