NCT06169436

Brief Summary

Observational study on relapse occurrence and on the quality of life in patients who underwent nephroureterectomy surgery

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,250

participants targeted

Target at P75+ for all trials

Timeline
465mo left

Started Jul 2014

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 Progress24%
Jul 2014Jul 2064

Study Start

First participant enrolled

July 17, 2014

Completed
9.4 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
40.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2064

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2064

Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

50 years

First QC Date

November 23, 2023

Last Update Submit

December 5, 2023

Conditions

Keywords

Upper Urinary Tract Urothelial CarcinomaNephroureterectomy surgeryRelapseQuality of lifeDiagnosis and Treatment strategies

Outcome Measures

Primary Outcomes (1)

  • Clinical progression data collection

    Collection intended for the purpose of implementing diagnostic and therepautic strategies for the management of the disease in both the patient enrolled in the study and for future cases. Data will be collected in a dedicated internal database by means of medical records obtained during the patients' stay in the hospital and during follow up visits. The data collected includes anamnesis, data regarding surgery, laboratory exam and imaging exams.

    50 years

Study Arms (1)

Experimental

Patients with upper urinary tract urothelial cancer who underwent nephroureterectomy surgery

Procedure: Nephroureterectomy

Interventions

Removal of cancer mass by urether and kidney complete resection.

Experimental

Eligibility Criteria

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

Patients with upper tract urothelial cancer who underwent nephroureterectomy surgery.

You may qualify if:

  • years or older
  • Upper tract urothelial cancer diagnosis
  • Indication to cancer removal through nephroureterectomy surgery
  • Ability to read and sign the informed consent

You may not qualify if:

  • Age \< 18 years
  • Absence of upper tract urothelial cancer
  • Inability to read and sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

RECRUITING

MeSH Terms

Conditions

RecurrenceDisease

Interventions

Nephroureterectomy

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NephrectomyUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Francesco Montorsi, MD

    IRCCS Ospedale San Raffaele

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Montorsi, MD.

CONTACT

Francesco Fiorio, MSC

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 23, 2023

First Posted

December 13, 2023

Study Start

July 17, 2014

Primary Completion (Estimated)

July 17, 2064

Study Completion (Estimated)

July 17, 2064

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations