A 12-Gene Blood-Based Signature for Detecting Metastatic Bladder Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purposes of this study is to evaluate a new genetic-based test which will identify patients diagnosed with muscle-invasive bladder cancer before their surgery, who might have specific genes, which will increase their chances of recurrence of cancer after their surgery.

Some patients who are diagnosed with bladder cancer and have their had bladder removed, will have a recurrence of cancer sometime after their surgery. This recurrence is usually caused by tumor cells that originated from the bladder tumor and traveled to other parts of the body, which is called metastatic cancer. Some patients are more likely than others to have metastatic disease. This test may help in identifying these patients who might develop metastases from having these specific genes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Genetic Susceptibility to Tumor Recurrence and Progression in Patients With Non-Muscle Invasive Bladder Cancer

NCT00582387

Bladder Cancer Urinary Cancer Nonmuscle Invasive Bladder Cancer

COMPLETED

A Genotype-Phenotype Urothelial Cancer Registry

NCT00902590

Urothelial Cancer Renal Pelvis Cancer Ureter Cancer +1 more

ACTIVE_NOT_RECRUITING

Genetic Analysis of Blood and Tissue Samples From Patients With Advanced Cancer, Moonshot Study

NCT03707574

Advanced Malignant Neoplasm Advanced Melanoma Advanced Renal Cell Carcinoma +51 more

ACTIVE_NOT_RECRUITING

Detection of Oncogenic Tumor Mutations in the Urine and Blood of Lung and Colorectal Cancer Patients

NCT02186236

Lung Cancer Colorectal Cancer

COMPLETED

Collecting and Storing Blood Samples From Patients With Cancer

NCT00900120

Brain and Central Nervous System Tumors Chronic Myeloproliferative Disorders Leukemia +8 more

WITHDRAWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bladder Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Blood sample

the blood sample only collected prior to surgery

Blood draw

Intervention Type GENETIC

The research intervention is the blood sample only collected prior to surgery. Analyses of the data will be made by correlating the gene profile expression with the pathologic finding at surgery and the clinical status of the patients 2 years after surgery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood draw

The research intervention is the blood sample only collected prior to surgery. Analyses of the data will be made by correlating the gene profile expression with the pathologic finding at surgery and the clinical status of the patients 2 years after surgery.

Intervention Type GENETIC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients in whom pelvic lymph node dissection can be performed;
* Any male and/or female, who is ≥18 years of age;
* Pathological diagnosis of urothelial carcinoma of the bladder;
* Localized muscle-invasive disease defined as clinical stage T2-4aN0M0 tumors;
* Did not receive neoadjuvant therapy;
* No radiographic evidence of metastatic disease on CT scans of the abdomen and pelvis, chest x-ray, or bone scan;
* Informed consent before study participation

Exclusion Criteria

* Prior systemic chemotherapy;
* Prior radiation therapy;
* A history of another ongoing malignancy within the past 5 years other than basal cell carcinoma of the skin

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No