NCT06868927

Brief Summary

This project aims to provide an accurate strategy to guide the decision making relying on tumor biopsies using standard histology, immunohistochemistry (IHC), spatial transcriptomics, genomics combined with Magnetic Resonance Imaging (MRI) and radiomics. Moreover, the investigators will explore potential markers indicative of response to systemic agents or ablative therapy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
45mo left

Started Sep 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Sep 2025Dec 2029

First Submitted

Initial submission to the registry

February 26, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

September 26, 2025

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

4.3 years

First QC Date

February 26, 2025

Last Update Submit

March 16, 2026

Conditions

Renal Tumors

Outcome Measures

Primary Outcomes (1)

  • accuracy of multiparametric preoperative MRI

    Detection of "Unfavourable outcome" is defined as the presence of at least one of the following pathological characteristics: * High grade tumor (G3 or G4) * Not-organ confined disease (pT3 and or pT4 and/or LNI) * Sarcomatoid features

    At final pathological assessment , at least 1 month after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

subjects with a renal tumor up to 4 cm and candidates for surgery

You may qualify if:

  • Presence of a renal mass up to 4 cm
  • Adult \> 18 years
  • Candidate to renal surgery
  • Informed consent signed

You may not qualify if:

  • Contraindication for MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Italia, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

Umberto Capitanio

CONTACT

3492503788caitanio.umberto@hsr.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Group Leader Renal Cancer Lab

Study Record Dates

First Submitted

February 26, 2025

First Posted

March 11, 2025

Study Start

September 26, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

March 17, 2026

Record last verified: 2026-03

Locations

IT(1)