Childhood Atypical Teratoid/Rhabdoid TumorNCT01453465
Biomarker Study in Samples From Patients With Malignant Rhabdoid Tumor of the Kidney or Atypical Teratoid Rhabdoid Tumor
An observational study of Childhood Atypical Teratoid/Rhabdoid Tumor and Rhabdoid Tumor of the Kidney, run by Children's Oncology Group at 1 site in United States.
Trial summary
This research trial studies biomarkers in samples from patients with rhabdoid tumor of the kidney and atypical teratoid rhabdoid tumor. Studying biomarkers of tissue samples from patients with cancer in the laboratory may help doctors learn more about changes the 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 Atypical Teratoid/Rhabdoid Tumor, Rhabdoid Tumor of the Kidney
- What is being tested?
- Laboratory Biomarker Analysis
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2011to 1 Dec 2011
- 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
- Samples of RTK and ATRT provided by the Children?s Oncology Group (COG)
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: Gene Expression (GE) and MicroRNA (MIRNA) Expression Profiles of Malignant Rhabdoid Tumors (MRT) of the Kidney (RTK) and Atypical Teratoid Rhabdoid Tumor (ATRT)
This research trial studies biomarkers in samples from patients with rhabdoid tumor of the kidney and atypical teratoid rhabdoid tumor. Studying biomarkers of tissue samples from patients with cancer in the laboratory may help doctors learn more about changes the occur in DNA and identify biomarkers related to cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if there are molecular differences between rhabdoid tumor of the kidney (RTK) and the atypical teratoid rhabdoid tumor (ATRT).
OUTLINE:
Archived tumor tissue samples are analyzed for gene expression profile and microRNA profile.
- Being tested
- Laboratory Biomarker Analysis
- Medical subject headings
- Rhabdoid Tumor
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 |
|---|---|---|
| Ancillary-Correlative (gene expression profile, miRNA profile) | Archived tumor tissue samples are analyzed for gene expression profile and microRNA profile. Receives: Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular differences between RTK and the ATRT
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study start1 Nov 2011
- Primary completion1 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Atypical Teratoid/Rhabdoid TumorStudies 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
- 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
- Simone Sredni, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453465
- Sponsor's protocol ID
- ABTR12B1
- Other IDs
- NCI-2011-03468, CDR0000712872, ABTR12B1, COG-ABTR12B1, ABTR12B1, ABTR12B1
- Status last verified
- Oct 2017
- First submitted
- 1 Oct 2011
- 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
- Gene Expression (GE) and MicroRNA (MIRNA) Expression Profiles of Malignant Rhabdoid Tumors (MRT) of the Kidney (RTK) and Atypical Teratoid Rhabdoid Tumor (ATRT)
- ClinicalTrials.gov ID
- NCT01453465
- Acronym / sponsor ID
- ABTR12B1
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 1 Dec 2011 (actual)
- First posted
- 17 Oct 2011 (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 research trial studies biomarkers in samples from patients with rhabdoid tumor of the kidney and atypical teratoid rhabdoid tumor. Studying biomarkers of tissue samples from patients with cancer in the laboratory may help doctors learn more about changes the occur in DNA and identify biomarkers related to cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine if there are molecular differences between rhabdoid tumor of the kidney (RTK) and the atypical teratoid rhabdoid tumor (ATRT).
OUTLINE:
Archived tumor tissue samples are analyzed for gene expression profile and microRNA profile.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (gene expression profile, miRNA profile) | – | Other: Laboratory Biomarker AnalysisArchived tumor tissue samples are analyzed for gene expression profile and microRNA profile. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Samples of RTK and ATRT provided by the Children?s Oncology Group (COG)
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 | Ancillary-Correlative (gene expression profile, miRNA profile) |
Primary outcome
Molecular differences between RTK and the ATRT
Time frame: Up to 3 months
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 Atypical Teratoid/Rhabdoid Tumor
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
Active, not recruitingPhase 2
Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma
Brain and Central Nervous System Tumors
RecruitingPhase 1
Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)
Medulloblastoma, Childhood, Atypical Teratoid/Rhabdoid Tumor of CNS
RecruitingPhase 1
GPC2-CAR T Cell Therapy for Relapsed or Refractory Medulloblastoma in Children and Young Adults
Medulloblastoma, Central Nervous System Embryonal Tumor
RecruitingPhase 1
HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors
Neoplasms, Brain, Glioblastoma Multiforme
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.
Simone Sredni 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 Atypical Teratoid/Rhabdoid Tumor and Rhabdoid Tumor of the Kidney, 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 1 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?
Molecular differences between RTK and the ATRT (time frame: Up to 3 months). 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.