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Recruiting

NCT Number: NCT06169436

Translational Cancer Observational Protocol

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

Recruiting

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Key information

Conditions

Upper Urinary Tract Urothelial Carcinoma Disease Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

Location status: Recruiting

Location contact

Francesco Fiorio, MSC

CONTACT

[email protected]

02 2643 6268

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nephroureterectomy

Procedure

Removal of cancer mass by urether and kidney complete resection.

Primary outcomes

  1. Clinical progression data collection

    Time frame: 50 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Fiorio, MSC

CONTACT

[email protected]

02 2643 6268

Francesco Montorsi, MD.

CONTACT

[email protected]

02 2643 7286

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

2014 Transizionali - Observational Study on the Occurrence of Relapses and on the Quality of Life in Patients Who Underwent Nephroureterectomy Surgery

Important dates

Study start
2014
Primary completion
2064
Study completion
2064
First posted
Dec 13, 2023
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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