Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00026884 |
Recruitment Status :
Recruiting
First Posted : November 15, 2001
Last Update Posted : January 25, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Malignant Neoplasms Hereditary Neoplastic Syndromes Kidney Cancer Renal Cancer Bladder Cancer |

Study Type : | Observational |
Estimated Enrollment : | 5000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Diseases |
Actual Study Start Date : | March 12, 1998 |
Group/Cohort |
---|
Family Members
Family members (related by blood) of patients who have or are suspected of having a malignant disease or an inherited genitourinary malignant disorder
|
Patients
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
|
- Investigate quality of life in men who have prostate cancer. [ Time Frame: on-going ]Prostate cancer patients 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 patients 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 patients with known or suspected cancer. [ Time Frame: on-going ]Collection of blood, urine, saliva, and/or benign and malignant tissue

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
- 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 adults unable to consent or 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026884
Contact: Deborah A Nielsen, R.N. | (240) 760-6247 | deborah.nielsen@nih.gov | |
Contact: W. Marston Linehan, M.D. | (240) 858-3700 | linehanm@mail.nih.gov |
United States, Maryland | |
National Institutes of Health Clinical Center | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937 |
Principal Investigator: | W. Marston Linehan, M.D. | National Cancer Institute (NCI) |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00026884 |
Obsolete Identifiers: | NCT00897585 |
Other Study ID Numbers: |
970147 97-C-0147 |
First Posted: | November 15, 2001 Key Record Dates |
Last Update Posted: | January 25, 2023 |
Last Verified: | November 9, 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | .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. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Time Frame: | Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active. |
Access Criteria: | Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.@@@@@@Genomic data are made available via dbGaP through requests to the data custodians. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Serum Collection of Tissue Malignant Disease |
Molecular Basis Genome Sequencing Natural History |
Neoplasms Kidney Neoplasms Neoplastic Syndromes, Hereditary Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Urologic Diseases Kidney Diseases Genetic Diseases, Inborn |