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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Diseases

Conditions
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Malignant Neoplasms, Hereditary Neoplastic Syndromes, Kidney Cancer, Renal Cancer, Bladder Cancer

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Family Members<br>Family members (related by blood) of patients who have or are suspected of having a malignant disease or an inherited genitourinary malignant disorder | |
| Patients<br>Patients with biopsy-proven malignant diseases; or patients suspected of having a malignant disease; or patients who have or who are suspected of having an inherited genitourinary malignant disorder | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate quality of life in men who have prostate cancer. | Prostate cancer patients that have improvement in quality of life | on-going | 
| Investigate molecular genetic basis of urologic malignancies | Investigate molecular genetic basis of urologic malignancies | on-going | 
| Investigate cellular/biochemical response to existing and novel therapeutic agents. | Collection of blood, urine, saliva, and/or benign and malignant tissue | on-going | 
| Examine protein expression and bioimmunoassays investigating potential genetic markers. | Detection and expression analysis of gene(s) | on-going | 
| Determine the molecular genetic differences between normal and tumorigenic tissues. | Molecular genetic differences between normal and tumorigenic tissues | on-going | 
| Collection of benign and malignant tissue from patients with rare inherited conditions associated with an increased risk for kidney cancer. | Collection of blood, urine, saliva, and/or benign and malignant tissue | on-going | 
| Collection of benign and malignant tissue from patients with known or suspected cancer. | Collection of blood, urine, saliva, and/or benign and malignant tissue | on-going | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serum, Collection of Tissue, Malignant Disease, Molecular Basis, Genome Sequencing, Natural History