NeoplasmsNCT00490334
Assessment and Rehabilitation of Cognitive Impairments in Pediatric Survivors of Cancer
An observational study of Neoplasms, run by Stanford University at 1 site in United States.
Trial summary
This research involves assessment of cognitive outcome in childhood cancer as well as evaluation of a cognitive rehabilitation program for improving learning and problem solving difficulties in children with cancer. Read more about this study
- Who is it for?
- Ages 9 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Neoplasms
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to 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 9 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric cancer patients 8 to 16 years of age, with age- and gender-matched control group.
Who may be able to join
- Everyone:
- At least 9 years of age and less than 17 years
- Patients
- Diagnosis of brain tumor or acute lymphocytic leukemia (ALL)
- Completed all anti-cancer treatment(s) including chemotherapy, radiation and/or surgery
- Control group
- Typical for age
Who cannot join
- Everyone:
- Non-English speaking (translated cognitive testing and MRI assessments unavailable)
- MRI contraindication, including but not limited to orthodontia, metal implants, and/or pacemaker
- Major sensory deficit disorders, including but not limited to blindness or deafness
- Patients
- Shunt placement
Show all 11Show fewer
- Received bone marrow transplant
- History of neurologic, psychiatric, developmental or major medical condition (eg, diabetes) NOT related to cancer
- Participation in any concurrent cognitive rehabilitation study
- Control group
- History of neurologic, psychiatric, developmental or major medical condition (eg, diabetes)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
This research involves assessment of cognitive outcome in childhood cancer as well as evaluation of a cognitive rehabilitation program for improving learning and problem solving difficulties in children with cancer.
Read the detailed description
The purpose of this study is to help determine specific cognitive-behavioral and neurobiologic impairments associated with chemotherapy treatments in children with cancer and to assess the efficacy of a cognitive intervention program for improving cognitive impairments in these children.
- Conditions
- Neoplasms
- Keywords
- Carcinomas, Squamous Cel, Adenocarcinoma, Acute Lymphocytic Leukemia
- Medical subject headings
- Neoplasms, Carcinoma, Adenocarcinoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma
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 |
|---|---|---|
| Cancer patients | Children with cancer aged 8 to 16 years | |
| Control (non-cancer) | Normal children aged 8 to 16 years, age- and gender-matched to the cancer cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on neuropsychological testing and brain activation patterns measured by functional MRI
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2007 (estimated)
- Study startAug 2007
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shelli Kesler, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490334
- Sponsor's protocol ID
- IRB-08123
- Other IDs
- 97817, PEDSVAR0003
- Status last verified
- May 2015
- First submitted
- 20 Jun 2007
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Rehabilitation of Cognitive Impairments in Pediatric Survivors of Cancer
- ClinicalTrials.gov ID
- NCT00490334
- Acronym / sponsor ID
- IRB-08123
- Conditions
- Neoplasms
- Keywords
- Carcinomas, Squamous Cel, Adenocarcinoma, Acute Lymphocytic Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Jun 2007 (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 involves assessment of cognitive outcome in childhood cancer as well as evaluation of a cognitive rehabilitation program for improving learning and problem solving difficulties in children with cancer.
Detailed description
The purpose of this study is to help determine specific cognitive-behavioral and neurobiologic impairments associated with chemotherapy treatments in children with cancer and to assess the efficacy of a cognitive intervention program for improving cognitive impairments in these children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | – | –Children with cancer aged 8 to 16 years |
| Control (non-cancer) | – | –Normal children aged 8 to 16 years, age- and gender-matched to the cancer cohort |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric cancer patients 8 to 16 years of age, with age- and gender-matched control group.
Key inclusion criteria (7 listed)
- At least 9 years of age and less than 17 years
- Patients
- Diagnosis of brain tumor or acute lymphocytic leukemia (ALL)
- Completed all anti-cancer treatment(s) including chemotherapy, radiation and/or surgery
- Control group
Key exclusion criteria (11 listed)
- Non-English speaking (translated cognitive testing and MRI assessments unavailable)
- MRI contraindication, including but not limited to orthodontia, metal implants, and/or pacemaker
- Major sensory deficit disorders, including but not limited to blindness or deafness
- Patients
- Shunt placement
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
Performance on neuropsychological testing and brain activation patterns measured by functional MRI
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Shelli Kesler principal investigator
Stanford University
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 Neoplasms, run by Stanford University 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 21 May 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Performance on neuropsychological testing and brain activation patterns measured by functional MRI (time frame: 8 weeks). 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 21 May 2015.