NCT06087016

Brief Summary

This study aims to evaluate the performance of vibrational spectroscopy (Infrared and Raman spectroscopy techniques) in bladder cancer diagnosis using urine samples.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2026

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

October 11, 2023

Last Update Submit

October 11, 2023

Conditions

Keywords

URINARY BLADDER NEOPLASMSDIAGNOSISURINEANALYSISSpectroscopyFourier Transform InfraredRamanSpectrum AnalysisMultivariate Analysis

Outcome Measures

Primary Outcomes (1)

  • Fourier Transform Infrared Spectroscopy

    Analyze urine samples by infrared spectroscopy after drying step and without any further sample preparation. The obtained spectra will be preprocessed and analyzed by multivariate algorithms to discriminate bladder cancer patients from control group.

    A 36 months

Secondary Outcomes (1)

  • Surface-enhanced Raman spectroscopy

    A 36 months

Study Arms (2)

Bladder cancer group

Bladder cancer group represents patients attending or hospitalized in Urology department, Reims University Hospital and in whom, tumor is visualized during cystoscopy and confirmed by the histological examination of entire resected lesion after Trans Urethral Resection of Bladder Tumor (TURBT).

Other: Urine vibrational analysis

Control group

Control group includes patients consulting for cystoscopy examination in Urology department, Reims University Hospital without any tumor visualization during cystoscopy examination.

Other: Urine vibrational analysis

Interventions

Urine vibrational analysis

Bladder cancer groupControl group

Eligibility Criteria

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

Patients attending for cystoscopy examination or hospitalized in Urology department, Reims University Hospital.

You may qualify if:

  • Must be over 18 years of age
  • Able to give consent and understand the purpose the study
  • Agree to participate in the study and having signed the non-objection document
  • Admitted to a urology consultation for cystoscopy

You may not qualify if:

  • Refused to participate in the study or unable to give consent
  • without a native bladder
  • with a bladder fistula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

MeSH Terms

Conditions

Urinary Bladder NeoplasmsDisease

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Stéphane LARRE

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 17, 2023

Study Start

March 6, 2023

Primary Completion

March 6, 2025

Study Completion

March 6, 2026

Last Updated

October 17, 2023

Record last verified: 2023-10

Locations