Clinical trial NCT00026884: Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease
Official title: Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Neoplasms
Hereditary Neoplastic Syndromes
Kidney Cancer
Renal Cancer
Bladder Cancer
Keywords: Serum
Collection of Tissue
Malignant Disease
Molecular Basis
Genome Sequencing
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2001-11-15
Enrollment: 5950
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Patients with biopsy-proven malignant disease 2. Patients suspected of having malignant disease 3. Patients with known or suspected urologic malignant disorders who have clinically indicated urologic or non-urologic surgical lesion 4. Family members of patients suspected of having an inherited genitourinary malignancy 5. Family members of patients with a DNA variant

Brief summary: 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: 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 criteria: * 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.

Primary outcomes:
measure: Investigate quality of life in men who have prostate cancer.
timeFrame: on-going
measure: Investigate molecular genetic basis of urologic malignancies
timeFrame: on-going
measure: Investigate cellular/biochemical response to existing and novel therapeutic agents.
timeFrame: on-going
measure: Examine protein expression and bioimmunoassays investigating potential genetic markers.
timeFrame: on-going
measure: Determine the molecular genetic differences between normal and tumorigenic tissues.
timeFrame: on-going
measure: Collection of benign and malignant tissue from patients with rare inherited conditions associated with an increased risk for kidney cancer.
timeFrame: on-going
measure: Collection of benign and malignant tissue from patients with known or suspected cancer.
timeFrame: on-going
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: W. Marston Linehan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: