Malignant NeoplasmsNCT00026884
Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease
An observational study of Malignant Neoplasms and Hereditary Neoplastic Syndromes, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Selected individuals 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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Neoplasms, Hereditary Neoplastic Syndromes, Kidney Cancer
- How many people
- 5,950 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 1998to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 1. Individuals with biopsy-proven malignant disease 2. Individuals suspected of having malignant disease 3. Individuals with known or suspected urologic malignant disorders who have clinically indicated urologic or non-urologic surgical lesion 4. Family members of individuals suspected of having an inherited genitourinary malignancy 5. Family members of individuals with a DNA variant
Who may be able to join
- Individuals with biopsy-proven malignant disease
- Individuals suspected of having a malignant disease
- Individuals who have or are suspected of having an inherited genitourinary malignant disorder
- Participants must be >= 2 years of age
- A relative (related by blood) of an individual with a confirmed or suspected diagnosis of a malignant disease or an inherited genitourinary malignant disorder.
- All participants and parents/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.
Who cannot join
- -Individuals whose co-morbidities preclude surgical intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
About this study
Official title: Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Diseases
Selected individuals 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....
Read the 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
- Individuals with biopsy-proven malignant disease
- Individuals suspected of having malignant disease
- Individuals with known or suspected inherited urologic malignant disorder
- A relative (related by blood) of an individual with a confirmed or suspected diagnosis of an inherited genitourinary disorder or malignancy
- Family members of patients with a DNA variant
Design
- Participants 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 participants undergoing clinically indicated surgical procedures
- Basic scientific research will be performed on collected specimens
- Participants 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
- 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
- Medical subject headings
- Neoplasms, Neoplastic Syndromes, Hereditary, Kidney Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Family Members | Family members (related by blood) of participants who have or are suspected of having a malignant disease or an inherited genitourinary malignant disorder | |
| Participants | Participants with biopsy-proven malignant diseases; or participants suspected of having a malignant disease; or participants who have or who are suspected of having an inherited genitourinary malignant disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate quality of life in men who have prostate cancer.
Prostate cancer participants that have improvement in quality of life
Measured: on-going
Investigate molecular genetic basis of urologic malignancies
Investigate molecular genetic basis of urologic malignancies
Measured: on-going
Investigate cellular/biochemical response to existing and novel therapeutic agents.
Collection of blood, urine, saliva, and/or benign and malignant tissue
Measured: on-going
Examine protein expression and bioimmunoassays investigating potential genetic markers.
Detection and expression analysis of gene(s)
Measured: on-going
Determine the molecular genetic differences between normal and tumorigenic tissues.
Molecular genetic differences between normal and tumorigenic tissues
Measured: on-going
Collection of benign and malignant tissue from individuals with rare inherited conditions associated with an increased risk for kidney cancer.
Collection of blood, urine, saliva, and/or benign and malignant tissue
Measured: on-going
Collection of benign and malignant tissue from individuals with known or suspected cancer.
Collection of blood, urine, saliva, and/or benign and malignant tissue
Measured: on-going
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2001 (estimated)
- Study start12 Mar 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- W. Marston Linehan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026884
- Sponsor's protocol ID
- 970147
- Other IDs
- 97-C-0147
- Status last verified
- 2 Nov 2026
- First submitted
- 14 Nov 2001
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Publications
Merriman KM, Harmon SA, Belue MJ, Yilmaz EC, Blake Z, Lay NS, Phelps TE, Merino MJ, Parnes HL, Law YM, Gurram S, Wood BJ, Choyke PL, Pinto PA, Turkbey B. Comparison of MRI-Based Staging and Pathologic Staging for Predicting Biochemical Recurrence of Prostate Cancer After Radical Prostatectomy. AJR Am J Roentgenol. 2023 Dec;221(6):773-787. doi: 10.2214/AJR.23.29609. Epub 2023 Jul 5.
PubMed 37404084
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Diseases
- ClinicalTrials.gov ID
- NCT00026884
- Acronym / sponsor ID
- 970147
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,950 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 12 Mar 1998 (actual)
- First posted
- 15 Nov 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Selected individuals 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
- Individuals with biopsy-proven malignant disease
- Individuals suspected of having malignant disease
- Individuals with known or suspected inherited urologic malignant disorder
- A relative (related by blood) of an individual with a confirmed or suspected diagnosis of an inherited genitourinary disorder or malignancy
- Family members of patients with a DNA variant
Design
- Participants 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 participants undergoing clinically indicated surgical procedures
- Basic scientific research will be performed on collected specimens
- Participants 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Members | – | –Family members (related by blood) of participants who have or are suspected of having a malignant disease or an inherited genitourinary malignant disorder |
| Participants | – | –Participants with biopsy-proven malignant diseases; or participants suspected of having a malignant disease; or participants who have or who are suspected of having an inherited genitourinary malignant disorder |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Individuals with biopsy-proven malignant disease 2. Individuals suspected of having malignant disease 3. Individuals with known or suspected urologic malignant disorders who have clinically indicated urologic or non-urologic surgical lesion 4. Family members of individuals suspected of having an inherited genitourinary malignancy 5. Family members of individuals with a DNA variant
Key inclusion criteria (6 listed)
- Individuals with biopsy-proven malignant disease
- Individuals suspected of having a malignant disease
- Individuals who have or are suspected of having an inherited genitourinary malignant disorder
- Participants must be >= 2 years of age
- A relative (related by blood) of an individual with a confirmed or suspected diagnosis of a malignant disease or an inherited genitourinary malignant disorder.
Key exclusion criteria (1 listed)
- -Individuals whose co-morbidities preclude surgical intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Investigate quality of life in men who have prostate cancer.
Time frame: on-going
Prostate cancer participants that have improvement in quality of life
Investigate molecular genetic basis of urologic malignancies
Time frame: on-going
Investigate molecular genetic basis of urologic malignancies
Investigate cellular/biochemical response to existing and novel therapeutic agents.
Time frame: on-going
Collection of blood, urine, saliva, and/or benign and malignant tissue
Examine protein expression and bioimmunoassays investigating potential genetic markers.
Time frame: on-going
Detection and expression analysis of gene(s)
Determine the molecular genetic differences between normal and tumorigenic tissues.
Time frame: on-going
Molecular genetic differences between normal and tumorigenic tissues
Collection of benign and malignant tissue from individuals with rare inherited conditions associated with an increased risk for kidney cancer.
Time frame: on-going
Collection of blood, urine, saliva, and/or benign and malignant tissue
Collection of benign and malignant tissue from individuals with known or suspected cancer.
Time frame: on-going
Collection of blood, urine, saliva, and/or benign and malignant tissue
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Derived from this study: PubMed 37404084Merriman KM, Harmon SA, Belue MJ, Yilmaz EC, Blake Z, Lay NS, Phelps TE, Merino MJ, Parnes HL, Law YM, Gurram S, Wood BJ, Choyke PL, Pinto PA, Turkbey B. Comparison of MRI-Based Staging and Pathologic Staging for Predicting Biochemical Recurrence of Prostate Cancer After Radical Prostatectomy. AJR Am J Roentgenol. 2023 Dec;221(6):773-787. doi: 10.2214/AJR.23.29609. Epub 2023 Jul 5.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
W. Marston Linehan, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasms and Hereditary Neoplastic Syndromes, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah A Nielsen, R.N. ((240) 760-6247, deborah.nielsen@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate quality of life in men who have prostate cancer. (time frame: on-going). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00026884, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.