Image

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

Recruiting
2 years and older
All
Phase N/A

Powered by AI

Overview

Selected patients suspected of having or with prior biopsy proof of malignant disease will be seen in the Urologic Oncology Branch, NCI. Blood samples may be collected at the time of the initial visit and at periodic intervals during the course of the disease. These samples will be stored in the tissue bank of the Urologic Oncology Branch. Aliquots of malignant and normal tissue will be collected at the time of surgery and stored in the tissue bank, Urologic Oncology Branch, NCI. These materials will be used in the research efforts of the Urologic Oncology Branch, NCI....

Description

Background

Kidney, prostate, bladder, testis and penile cancer account for 22% of cancers diagnosed in the United States and are responsible for 10% of cancer deaths each year in the U.S. Understanding the genes and gene pathways that cause genitourinary malignancies will provide the foundation for the development of targeted therapeutic agents for patients affected with these cancers. Since 1982 investigators in the Urologic Oncology Branch have been studying the genetic basis of urologic cancers. The identification of the genes for cancer of the kidney has led to the approval by the FDA of a number of new agents for patients with advanced disease. It is our goal to study the cancer gene pathways of genitourinary malignancies in order to further understand the cancer gene pathways that cause these diseases.

Objectives

Collection of benign and malignant tissue from patients with known or suspected cancer

Collection of benign and malignant tissue from patients with rare inherited conditions associated with an increased risk for kidney cancer

Determine the molecular genetic differences between normal and tumorigenic tissues

Investigate the categories of genes/ biochemical pathways such as those that influence the cell cycle, angiogenesis, metabolic changes, and metastatic potential

Examine protein expression and bioimmunoassays investigating potential genetic markers

Investigate cellular/biochemical response to existing and novel therapeutic agents.

Investigate quality of life in men who have prostate cancer

Investigate molecular genetic basis of urologic malignancies

Examine cell free DNA and circulating tumor DNA for cancer gene mutations

Eligibility

Patients with biopsy-proven malignant disease

Patients suspected of having malignant disease

Patients with known or suspected inherited urologic malignant disorder

Family members (related by blood) of patients who have or are suspected of having an inherited genitourinary disorder or malignancy

Family members of patients with a DNA variant

Design

Patients will be screened for eligibility in the Urologic Oncology Branch Clinic

Blood and urine samples may be obtained

Normal and malignant tissue may be collected from patients undergoing clinically indicated surgical procedures

Basic scientific research will be performed on collected specimens

Patients will have the option to be contacted if a result is detected that would affect their health and they will be given the opportunity to be evaluated and re-tested on an IRB approved protocol if available

Germline and somatic whole genome exome sequencing may be performed

Eligibility

  • INCLUSION CRITERIA:
    • Adult and minor patients with biopsy-proven malignant disease
    • Adult and minor patients suspected of having a malignant disease
    • Patients who have or are suspected of having an inherited genitourinary malignant disorder
    • Participants must be >= 2 years of age
    • Family members (related by blood) of patients who have or are suspected of having a malignant disease or an inherited genitourinary malignant disorder.
    • All patients and guardians, for children younger than 18 years of age, must sign an informed consent document indicating their understanding of the investigational nature and the risks of this study before any protocol related studies are performed. Patients under the age of 18 but who are age 13 or older will be asked to sign an assent document prior to participation.

EXCLUSION CRITERIA:

  • Subjects whose co-morbidities preclude surgical intervention.

Study details
    Malignant Neoplasms
    Hereditary Neoplastic Syndromes
    Kidney Cancer
    Renal Cancer
    Bladder Cancer

NCT00026884

National Cancer Institute (NCI)

25 June 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.