Kidney CancerNCT00899860
Gene Expression in Normal Tissue and Tumor Tissue From Patients Who Have Undergone Surgery For Kidney Cancer
An observational study of Kidney Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
RATIONALE: Studying the genes and proteins expressed in tissue samples from patients with cancer may help doctors identify biomarkers related to cancer. PURPOSE: This laboratory study is evaluating gene and protein expression in normal tissue and tumor tissue from patients who have undergone surgery for kidney cancer. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Kidney Cancer
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Those wiht histologically confirmed renal cell cancer who have underwent nephrectomy for renal cell cancer.
Who may be able to join
- Histologically confirmed renal cell cancer
- Clinical staging (if available)
- Underwent nephrectomy for renal cell cancer
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: Renal Cell Cancer Tumor Markers
RATIONALE: Studying the genes and proteins expressed in tissue samples from patients with cancer may help doctors identify biomarkers related to cancer.
PURPOSE: This laboratory study is evaluating gene and protein expression in normal tissue and tumor tissue from patients who have undergone surgery for kidney cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the expression levels of novel genes and proteins (HFARP, HAMGR28, HE9NG77) in frozen normal tissue and tumor tissue samples from patients who have undergone nephrectomy for renal cell cancer.
- Correlate gene and protein expression levels with disease stage, tumor size, and pathology reports (e.g., cell type, grade, and tissue architecture) in order to evaluate the rate of gene and protein expression as targets for future therapeutic interventions.
Secondary
- Compare proteomic screening of potential biomarkers using existing plasma and/or urine samples from patients with renal cell cancer or breast cancer stored in the CCCWFU Tumor Tissue Core with tissue samples from patients enrolled in this study.
OUTLINE: Normal and tumor tissue collected from patients who have undergone nephrectomy and diagnostic and therapeutic intervention for renal cell cancer is analyzed for histopathological expression and compared to normal kidney cells by northern blot. Tissue samples are evaluated by RNA and protein extraction and analyzed by gel electrophoresis, blotting, and phosphor-imaging for induction or suppression of genes and protein levels. These data are correlated with clinical stage, tumor size, and histopathological grade and architecture of the patient's disease.
- Conditions
- Kidney Cancer
- Keywords
- recurrent renal cell cancer, stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
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 |
|---|---|---|
| patients with renal cell cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression levels of novel genes and proteins (HFARP, HAMGR28, HE9NG77) in frozen normal tissue and tumor tissue
Measured: day 1
Correlation of gene and protein expression levels with disease stage, tumor size, and pathology reports
Measured: day 1
Secondary outcomes (1)
Comparison of proteomic screening of potential biomarkers using plasma and/or urine samples from patients with renal cell cancer or breast cancer stored in the CCCWFU Tumor Tissue Core with tissue samples from patients enrolled in this study
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startSep 2003
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Frank M. Torti, MD, MPH, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899860
- Sponsor's protocol ID
- CDR0000550079
- Other IDs
- P30CA012197, CCCWFU-89A03, CCCWFU-GB03-404
- Status last verified
- Jun 2012
- First submitted
- 9 May 2009
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Cell Cancer Tumor Markers
- ClinicalTrials.gov ID
- NCT00899860
- Acronym / sponsor ID
- CDR0000550079
- Conditions
- Kidney Cancer
- Keywords
- recurrent renal cell cancer, stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2003
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 12 May 2009 (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.
RATIONALE: Studying the genes and proteins expressed in tissue samples from patients with cancer may help doctors identify biomarkers related to cancer.
PURPOSE: This laboratory study is evaluating gene and protein expression in normal tissue and tumor tissue from patients who have undergone surgery for kidney cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the expression levels of novel genes and proteins (HFARP, HAMGR28, HE9NG77) in frozen normal tissue and tumor tissue samples from patients who have undergone nephrectomy for renal cell cancer.
- Correlate gene and protein expression levels with disease stage, tumor size, and pathology reports (e.g., cell type, grade, and tissue architecture) in order to evaluate the rate of gene and protein expression as targets for future therapeutic interventions.
Secondary
- Compare proteomic screening of potential biomarkers using existing plasma and/or urine samples from patients with renal cell cancer or breast cancer stored in the CCCWFU Tumor Tissue Core with tissue samples from patients enrolled in this study.
OUTLINE: Normal and tumor tissue collected from patients who have undergone nephrectomy and diagnostic and therapeutic intervention for renal cell cancer is analyzed for histopathological expression and compared to normal kidney cells by northern blot. Tissue samples are evaluated by RNA and protein extraction and analyzed by gel electrophoresis, blotting, and phosphor-imaging for induction or suppression of genes and protein levels. These data are correlated with clinical stage, tumor size, and histopathological grade and architecture of the patient's disease.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with renal cell cancer | – | – |
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Those wiht histologically confirmed renal cell cancer who have underwent nephrectomy for renal cell cancer.
Key inclusion criteria (3 listed)
- Histologically confirmed renal cell cancer
- Clinical staging (if available)
- Underwent nephrectomy for renal cell cancer
Key exclusion criteria (0 listed)
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
Expression levels of novel genes and proteins (HFARP, HAMGR28, HE9NG77) in frozen normal tissue and tumor tissue
Time frame: day 1
Correlation of gene and protein expression levels with disease stage, tumor size, and pathology reports
Time frame: day 1
1 secondary outcome
Comparison of proteomic screening of potential biomarkers using plasma and/or urine samples from patients with renal cell cancer or breast cancer stored in the CCCWFU Tumor Tissue Core with tissue samples from patients enrolled in this study
Time frame: day 1
Results and safety
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Related trials for Kidney Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingObservational study
Federated Learning in Renal Tumor Model
Renal Tumors
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Active, not recruiting
App-Based Mindfulness Intervention for the Improvement of Quality of Life in Patients With Metastatic Renal Cell Cancer
Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8
RecruitingPhase 2/3
Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
Renal Pelvis and Ureter Urothelial Carcinoma
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. This study is not recruiting at the moment.
Frank M. Torti, MD, MPH study chair
Wake Forest University Health Sciences
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 Kidney Cancer, run by Wake Forest University Health Sciences 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 3 inclusion and 0 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: stopped early, as of the sponsor's last update on 30 May 2017. 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?
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression levels of novel genes and proteins (HFARP, HAMGR28, HE9NG77) in frozen normal tissue and tumor tissue (time frame: day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2017.