PRediction of Outcomes and PERsonalized Radiotherapy by Biomarkers and Functional Imaging

NCT06730035 | Active Not Recruiting

• 2 other identifiers: PROPERRicerca Corrente 2022-2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Rectal Cancer, Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Pathological response

  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.

  through study completion, an average of 1 year

Study Arms (1)

Experimental analysis on tissues

EXPERIMENTAL

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.

Other: Blood analysis

Interventions

Blood analysis OTHER

This is an experimental analysis on tissues (peripheral blood) and exploratory, which is why the enrollment of a limited number of patients has been planned. 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. The qualitative and quantitative characteristics of the vesicles and their miRNA content will be analyzed descriptively.

Experimental analysis on tissues

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients candidates for neoadjuvant RT, administered with hypofractionated-accelerated treatment, for locally advanced rectal tumors;
• Age ≥ 18 years
• Obtaining informed consent

You may not qualify if:

• Contraindications to MRI, uncontrolled chronic intestinal diseases or pelvic infections
• Pregnancy and breastfeeding
• Unwillingness to participate in follow-up

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Alessio Giuseppe Morganti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 12, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

IT (1)