Clinical trial · Interventional
PRediction of Outcomes and PERsonalized Radiotherapy by Biomarkers and Functional Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a study focused on analyses of peripheral blood (tissue study). The aim of the trial is to determine whether it is possible to predict early clinical and/or pathological responses after radiotherapy in the setting of neoadjuvant treatment for locally advanced rectal carcinomas, through qualitative and quantitative assessment of circulating extracellular vesicles in plasma and the microRNA (miRNA) contained within them. Extracellular vesicles are "clean-up" structures that collect various elements circulating in the blood, including fragments of DNA and RNA from tumor cells. Observing how these structures and their contents change with radiotherapy could provide early indications of the tumor's response to treatment. The trial seeks to answer the question: "Can the quantity of CD69+ vesicles in patients undergoing neoadjuvant radiotherapy predict their response early?" The trial is monocentric and plans to enroll approximately 30 patients. Participation in this trial does not offer direct benefits, as it involves only laboratory investigations without modifications to the usual diagnostic-therapeutic process for the condition considered. The collection of information is aimed at improving knowledge regarding extracellular vesicles. These vesicles could provide early insights into the response to neoadjuvant radiotherapy for locally advanced rectal tumors. In this way, subsequent therapeutic strategies can be personalized based on this response.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer, Radiotherapy | Malignant Rectal Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental analysis on tissues
- description
- The results obtained from the study should not be considered conclusive but rather as generators of research hypotheses for potential subsequent studies to be conducted on larger populations.
- interventionNames
- Other: Blood analysis
Primary outcomes (1)
- measure
- Pathological response
- timeFrame
- through study completion, an average of 1 year
- description
- The response to therapy will be assessed as a complete pathological response, defined as present/absent according to the staging criteria commonly used in clinical practice.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients candidates for neoadjuvant RT, administered with hypofractionated-accelerated treatment, for locally advanced rectal tumors; * Age ≥ 18 years * Obtaining informed consent Exclusion Criteria: * Contraindications to MRI, uncontrolled chronic intestinal diseases or pelvic infections * Pregnancy and breastfeeding * Unwillingness to participate in follow-up
References
Publications (0)
Data not yet available