NCT04319263

Brief Summary

This retrospective study aimed at assessment of different patterns (morphological and pathological) of tumor recurrence found at first evaluation after BCG induction therapy (3 months cystoscopy) for intermediate and high-risk NMIBC and its prognostic implications at a tertiary referral center.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 1, 2020

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

17 days

First QC Date

March 20, 2020

Last Update Submit

March 24, 2020

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (2)

  • one year Recurrence rate

    recurrence rate at 1 year after induction BCG

    one year

  • one year progression rate

    progression rate at 1 year after induction BCG

    one year

Study Arms (1)

intermediate and high risk non muscle invasive bladder cancer

EXPERIMENTAL
Drug: induction regimen of intravesical BCG

Interventions

induction regimen of intravesical BCGDRUG

intravesical instillation of 6 weekly doses of BCG

intermediate and high risk non muscle invasive bladder cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients for who complete TURBT, was carried out
  • Intermediate and high risk NMIBC.
  • Patients who received full induction BCG regimen (6 weekly doses).
  • Patients completed at least 12 months follow up after 3 months cystoscopy.

You may not qualify if:

  • Patients who received incomplete induction BCG regimen (less than 6 weekly doses)
  • Patients with incomplete (less than 12 months) follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Amr A Elsawy

    Urology and Nephrology Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 20, 2020

First Posted

March 24, 2020

Study Start

March 1, 2020

Primary Completion

March 18, 2020

Study Completion

March 18, 2020

Last Updated

March 26, 2020

Record last verified: 2020-03

Locations

EG(1)