Trials Sponsors Conditions Drugs Pricing

Conditions

Bladder Cancer

Keywords

STCC (Superficial Transitional Cell Carcinoma)

Outcome Measures

Primary Outcomes (2)

Recording of any clinical adverse reactions at anytime during the study for assessment of safety
24 months
Recurrence Rate-Evaluated after 3 months by doing sonography, cystoscopy, and cytology
24 months

Secondary Outcomes (2)

Quality of Life- The measure of an individual's sense of well-being and ability to carry out various activities
24 months
Time to Tumor progression -will be evaluated every 3 months for 15 months during the study period
15

Study Arms (2)

Mw

EXPERIMENTAL

Mycobacterium w

Biological: Mycobacterium w

BCG

ACTIVE COMPARATOR

bacillus Calmette-Guerin (BCG)

Biological: BCG (Bacillus Calmette-Guerin)

Interventions

Mycobacterium wBiological

Immunomodulator

BCG (Bacillus Calmette-Guerin)Biological

Immunotherapeutic agent

Also known as: Bacillus Calmette Guerin

BCG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ability to understand and willingness to sign a written informed consent.
Patients with newly diagnosed superficial transitional cell carcinoma with completely resected papillary tumors and high probability of recurrence risk i.e. stage T1 Grade 2, T1 Grade 3 \& CIS.

Sponsors & Collaborators

Cadila Pharnmaceuticals
Industrylead

Study Sites (15)

Muljibhai Patel Urological Hospital

Nadiād, Gujarat, India

Urocare Hospital

Rajkot, Gujarat, 360002, India

Indira Gandhi Medical College

Shimla, Himachal Pradesh, 171001, India

N.R.R. Hospital

Bangalore, Karnataka, 560090, India

Kasturba Medical college and Hospital

Manipal, Karnataka, 576104, India

Lourdes Hospital

Kochi, Kerala, 682012, India

Choithram Hospital and Research Centre

Indore, Madhya Pradesh, 452014, India

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Mycobacterium w vaccineBCG Vaccine

Condition Hierarchy (Ancestors)

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

Study Officials

Mahesh Desai, MD
Muljibhai Patel Urological Hospital
PRINCIPAL INVESTIGATOR
N K Mohanty, MD
V M Medical College & Safdarjang Hospital
PRINCIPAL INVESTIGATOR
Amillal Bhat, MD
S P Medical College & AG of Hospitals
PRINCIPAL INVESTIGATOR
Sujata Patwardhan, MD
Seth G S Medical College & K E M Hospital
PRINCIPAL INVESTIGATOR

Enrollment

122 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 29, 2008

First Posted

June 11, 2008

Study Start

August 28, 2008

Actual (reported)

Primary Completion

Study of Mycobacterium w in Superficial Transitional Cell Carcinoma of Bladder

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

Mw

BCG

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (15)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

Mw

BCG

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (15)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations