Predicting true oligo-metastatic disease in colorectal cancer patients
Oligo-metastatic neoPlasms From the gastRo-intEstinal Tract: iDentIfiCaTIon Of cliNical and Molecular Drivers: the PREDICTION Study
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 |
|---|---|
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Cancer Institute, Naples Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT05806151 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with gastrointestinal tumors who have one to three lesions per organ and meet specific size criteria.
Not a fit: Patients with previous or concurrent malignant neoplasms or those with cerebral metastases may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Naples
- Alessandro Ottaiano — Naples, Italy (Recruiting)
Study contacts
- Study coordinator: Alessandro Ottaiano
- Email: a.ottaiano@istitutotumori.na.it
- Phone: +39 081 17770344
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.