Childhood Kidney NeoplasmNCT01642095
Studying Biomarkers in Samples From Younger Patients With Kidney Cancer
An observational study of Childhood Kidney Neoplasm and Clear Cell Renal Cell Carcinoma, run by Children's Oncology Group at 1 site in United States.
Trial summary
This laboratory study is looking into biomarkers in samples from younger patients with kidney cancer. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Childhood Kidney Neoplasm, Clear Cell Renal Cell Carcinoma, Congenital Mesoblastic Nephroma
- What is being tested?
- Laboratory Biomarker Analysis
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2012to 1 Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Formalin-fixed, paraffin-embedded tissue samples from patients diagnosed with the following renal tumors:
- Anaplastic Wilms tumor
- Malignant rhabdoid tumor of the kidney
- Clear cell sarcoma of the kidney
- Mesoblastic nephroma
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens Oncology Group
Philadelphia, Pennsylvania, 19104
About this study
Official title: Focal Adhesion Kinase Expression in Pediatric Renal Tumors
This laboratory study is looking into biomarkers in samples from younger patients with kidney cancer. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine whether focal adhesion kinase (FAK) is expressed and if FAK is phosphorylated in pediatric renal tumors.
OUTLINE:
Archived tumor tissue samples are analyzed for FAK expression by immunohistochemistry (IHC). IHC staining is compared in normal renal tissue, Wilms tumor (routine and anaplastic), malignant rhabdoid tumor of the kidney, clear cell sarcoma of the kidney, and mesoblastic nephroma.
- Conditions
- Childhood Kidney Neoplasm, Clear Cell Renal Cell Carcinoma, Congenital Mesoblastic Nephroma, Rhabdoid Tumor of the Kidney
- Being tested
- Laboratory Biomarker Analysis
- Medical subject headings
- Carcinoma, Renal Cell, Nephroma, Mesoblastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Basic science (FAK expression) | Archived tumor tissue samples are analyzed for FAK expression by IHC. IHC staining is compared in normal renal tissue, Wilms tumor (routine and anaplastic), malignant rhabdoid tumor of the kidney, clear cell sarcoma of the kidney, and mesoblastic nephroma. Receives: Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
FAK expression in pediatric renal tumors
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study start22 Aug 2012
- Primary completion1 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Kidney NeoplasmStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Beierle, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642095
- Sponsor's protocol ID
- AREN12B8
- Other IDs
- NCI-2012-01987, CDR0000736805, AREN12B8, COG-AREN12B8, AREN12B8, AREN12B8
- Status last verified
- Oct 2017
- First submitted
- 15 Jul 2012
- Last updated
- 7 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Adhesion Kinase Expression in Pediatric Renal Tumors
- ClinicalTrials.gov ID
- NCT01642095
- Acronym / sponsor ID
- AREN12B8
- Conditions
- Childhood Kidney Neoplasm, Clear Cell Renal Cell Carcinoma, Congenital Mesoblastic Nephroma, Rhabdoid Tumor of the Kidney
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Aug 2012 (actual)
- Primary completion
- 1 Sep 2012 (actual)
- First posted
- 17 Jul 2012 (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.
This laboratory study is looking into biomarkers in samples from younger patients with kidney cancer. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine whether focal adhesion kinase (FAK) is expressed and if FAK is phosphorylated in pediatric renal tumors.
OUTLINE:
Archived tumor tissue samples are analyzed for FAK expression by immunohistochemistry (IHC). IHC staining is compared in normal renal tissue, Wilms tumor (routine and anaplastic), malignant rhabdoid tumor of the kidney, clear cell sarcoma of the kidney, and mesoblastic nephroma.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic science (FAK expression) | – | Other: Laboratory Biomarker AnalysisArchived tumor tissue samples are analyzed for FAK expression by IHC. IHC staining is compared in normal renal tissue, Wilms tumor (routine and anaplastic), malignant rhabdoid tumor of the kidney, clear cell sarcoma of the kidney, and mesoblastic nephroma. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Formalin-fixed, paraffin-embedded tissue samples from patients diagnosed with the following renal tumors:
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Basic science (FAK expression) |
Primary outcome
FAK expression in pediatric renal tumors
Time frame: Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
Related trials for Childhood Kidney Neoplasm
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 2
Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Recurrent Childhood Ependymoma
RecruitingObservational study
Biomarkers of Resiliency In Childhood Cancer Surgery
Pediatric Cancer, Neuroblastoma
Active, not recruitingPhase 2
Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors
Adrenal Cortical Carcinoma, Alveolar Soft Part Sarcoma
RecruitingObservational study
Project: Every Child for Younger Patients With Cancer
Adrenal Gland Pheochromocytoma, Carcinoma In Situ
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.
Elizabeth Beierle principal investigator
Children's Oncology Group
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 Childhood Kidney Neoplasm and Clear Cell Renal Cell Carcinoma, run by Children's Oncology Group 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 5 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: withdrawn, as of the sponsor's last update on 7 Aug 2018. 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 withdrawn before enrolling participants, so there are no results.
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?
FAK expression in pediatric renal tumors (time frame: Baseline). 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 7 Aug 2018.