Predicting true oligo-metastatic disease in colorectal cancer patients
Official title: Oligo-metastatic neoPlasms From the gastRo-intEstinal Tract: iDentIfiCaTIon Of cliNical and Molecular Drivers: the PREDICTION Study
Run by National Cancer Institute, Naples · NCT05806151 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is trying to see if certain genetic and immune features can help tell apart patients with colorectal cancer who have a limited number of tumors from those with more widespread disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | National Cancer Institute, Naples Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT05806151 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients diagnosed with gastrointestinal tumors who have one to three lesions per organ and meet specific size criteria.
✕Probably not a fit
Patients with previous or concurrent malignant neoplasms or those with cerebral metastases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to differentiate between true oligo-metastatic disease (OMD) and poly-metastatic disease in patients with gastrointestinal tumors, particularly colorectal cancer. It will assess the prevalence of specific biological characteristics, including genetic and immunologic profiles, in patients diagnosed with OMD. The study will utilize genetic assessments from formalin-fixed paraffin-embedded tissues or liquid biopsies to gather data on the tumor's genetic landscape and T lymphocyte infiltrate. The findings could help refine treatment strategies for patients with OMD.
Why it matters
Potential benefit: If successful, this study could lead to more accurate prognostic assessments and tailored treatment options for patients with oligo-metastatic disease.
How similar studies have gone: While the differentiation of metastatic disease types is a recognized area of interest, this specific approach to predicting true OMD is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients eligible for inclusion in this study must meet the following criteria: * Diagnosis of gastroenteric tumors (colon, stomach, biliary tract, exocrine glands of the digestive tract); * OMD: one to three lesions per organ with a maximum tumor diameter of less than 70 mm and no lesion with a diameter greater than 25 mm; * Availability of FFPE (Formalin Fixed Paraffin Embedded) inclusions from resected primary tumor; * Written informed consent. Exclusion Criteria: * Previous or concurrent malignant neoplasms; * Presence of cerebral metastases; * Refusal or inability to provide informed consent; * Inability to guarantee follow-up.
Where it's running
-
Alessandro Ottaiano
Naples, Italy Recruiting
Study contacts
- Study coordinator: Alessandro Ottaiano
- Email: a.ottaiano@istitutotumori.na.it
- Phone: +39 081 17770344
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Immediate simulation-free SBRT for people with up to five metastatic tumors
This tests whether giving stereotactic body radiation therapy (SBRT) right away without a separate CT simulation helps people with up to five metastatic cancer spots get treatment faster.
-
Stereotactic ablative radiotherapy versus single‑fraction palliative radiotherapy for oligoprogressive metastatic cancer
This trial will test whether stereotactic ablative radiotherapy (SABR) works better than single‑fraction palliative radiotherapy (8 Gy) for people with 1–5 oligoprogressive metastatic lesions to delay the need for next‑line systemic therapy and improve quality of life.
-
Chemoimmunotherapy followed by surgery for limited spread esophageal and gastric cancer
This study is testing if a combination of chemotherapy, immunotherapy, and surgery can help people with a limited spread of esophageal or gastric cancer live longer and have fewer recurrences.
-
Combining radiotherapy with systemic therapy for oligometastatic ureter cancer
This study tests if adding radiotherapy to standard treatment can help people with a limited number of metastatic ureter cancer spots feel better and live longer.
-
Stereotactic radiotherapy for patients with oligometastatic cancer
This study tests whether a special type of targeted radiation therapy can help people with a few metastatic tumors feel better compared to standard care after chemotherapy.
-
Single‑fraction versus multiple‑fraction SBRT for treating limited metastases (SPRINT)
This trial will test whether a single high‑dose SBRT treatment works as safely and effectively as multiple smaller SBRT treatments for people with limited metastases from breast, prostate, lung, or colorectal cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.