Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026884
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2001-11-14
Brief Title:
Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Diseases
Status:
RECRUITING
Status Verified Date:
2024-09-26
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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 cellularbiochemical 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
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 US 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 cellularbiochemical 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-C-0147 | None | None | None |