Translational Cancer Observational Protocol | NCT06169436

Studies
Translational Cancer Observational Protocol

NCT06169436

Sponsor

IRCCS San Raffaele

Status

Recruiting

Last Update Posted

Dec 13, 2023Actual

Enrollment

1,250Estimated

Phase

Not provided

Conditions

Upper Urinary Tract Urothelial Carcinoma

Interventions

Nephroureterectomy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 17, 2014Actual

Primary Completion Date

Jul 17, 2064Estimated

Completion Date

Jul 17, 2064Estimated

First Submitted Date

Nov 23, 2023

First Submission Date that Met QC Criteria

Dec 5, 2023

First Posted Date

Dec 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2023

Last Update Posted Date

Dec 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Monocentric prospective and retrospective observational study on the quality of life and on the pathological status in patients who underwent nephroureterectomy surgery. Oncological, psychological, sexual and quality of life-related data will be collected within a specifically created database that will allow us an easy and secure data extraction for the statistical analysis required by the clinical trial in terms of oncological relapse, clinical progression and improve the assistance and therapeutic strategy for each patient. Retrospective data for patients who underwent surgery between 1987 and today will be available in the form of clinical report stored in the hospital archives.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental		Patients with upper urinary tract urothelial cancer who underwent nephroureterectomy surgery	Procedure: Nephroureterectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nephroureterectomy	Procedure	Removal of cancer mass by urether and kidney complete resection.	Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with upper tract urothelial cancer who underwent nephroureterectomy surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Francesco Montorsi, MD.	Contact	02 2643 7286		montorsi.francesco@hsr.it
Francesco Fiorio, MSC	Contact	02 2643 6268		fiorio.francesco@hsr.it

Overall Officials

Name	Affiliation	Role
Francesco Montorsi, MD	IRCCS Ospedale San Raffaele	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Ospedale San Raffaele	Recruiting	Milan	MI	20132	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012008	Recurrence
D004194	Disease

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000074682	Nephroureterectomy

Ancestor Terms

ID	Term
D009392	Nephrectomy
D013520	Urologic Surgical Procedures
D013519	Urogenital Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided