Prognostic Performance of a Chemogram in Patients With Bladder Cancer.

NCT06403202 | Recruiting

• 1 other identifier: RC-P0095
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate chemogram in patients with intermediate-grade superficial bladder cancer and patients with infiltrating bladder cancer, who are likely to be treated according to the standard procedure. This project is based on the premise that treatments - notably chemotherapy - are standard, but that each cancer is unique. It is therefore necessary to personalize the treatment for each patient, while at the same time proposing an approach that is economically bearable for the healthcare system. For both types of bladder tumor, chemotherapy is used either as an alternative to immunotherapy, or as an adjuvant to surgery. Its use is therefore based on its effectiveness in reducing post-treatment recurrence.

Conditions

Urinary Bladder Neoplasms

Keywords

Urinary Bladder Neoplasms; Chemogram

Outcome Measures

Primary Outcomes (4)

• Chemogram sensitivity

  The relevance of the chemogram to the patient's response to treatment will be assessed by calculating sensitivities, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment.

  12 months

• Chemogram specificity

  The relevance of the chemogram to the patient's response to treatment will be assessed by calculating specificity, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment.

  12 months

• Positive predictive value

  The relevance of the chemogram to the patient's response to treatment will be assessed by calculating positive predictive value, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment.

  12 months

• Negative predictive value

  The relevance of the chemogram to the patient's response to treatment will be assessed by calculating negative predictive value, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment.

  12 months

Secondary Outcomes (2)

• Proteomic analysis

  12 months

• Transcriptomic analysis

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with intermediate-grade superficial bladder cancer and invasive bladder cancer

You may qualify if:

• Major patient
• Patient with suspected bladder cancer likely to be treated with chemotherapy
• Patient affiliated to a social security scheme

You may not qualify if:

• Insufficient tumor volume
• Patient under guardianship
• Pregnant or breast-feeding women
• Patient opposed to participation in the study

Sponsors & Collaborators

• Lille Catholic University: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Hôpital St Philibert

Lomme, 59160, France

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jean-Louis Bonnal

  GHICL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Paule Lebitasy

CONTACT

033 3 20 22 52 69; lebitasy.marie-paule@ghicl.net

Berenice MARCHANT

CONTACT

03.20.22.57.51; marchant.berenice@ghicl.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: May 7, 2024
• Study Start: August 23, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

FR (1)