Prospective Pilot Study Identifying Clinically Relevant Biological Targets for Medical Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tumor and Blood Specimens.
- Who it may be relevant to
- Registry conditions: Craniopharyngioma, Child. Basic parameters: 30 Days — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Advancing Treatment for Pediatric Craniopharyngioma: Prospective Pilot Study Identifying Clinically Relevant Biological Targets for Medical Therapy
Overview
New data suggests that the current treatment for pediatric adamantinomatous craniopharyngioma (CPA) may not be as effective as it could be.
Detailed description
Current treatment regimens for pediatric CPA are limited to surgery and radiation therapy. This pilot study seeks to identify biologically rational therapeutics for the medical treatment of adamantinomatous CPA by confirming the overexpression of specific molecules.
Interventions
- Procedure Tumor and Blood Specimens
If available, specimen will be sampled from within the tumor, and not include portions of the tumor capsule. If the tumor includes a cyst, fluid from the cyst will be sampled if available. For each tumor specimen, a companion sample of blood that would otherwise be disposed of through usual clinical practice in the operating room will also be collected.
Primary outcome measures
- Identification of Potential Therapeutic Targets [Time frame: Beginning of study to end of study, up to 1 year.]
- Identification of Potential Therapeutic Targets [Time frame: Beginning of study to end of study, up to 1 year.]
- Identification of Potential Therapeutic Targets [Time frame: Beginning of study to end of study, up to 1 year.]
- Identification of Potential Therapeutic Targets [Time frame: Beginning of study to end of study, up to 1 year.]
- Identification of Potential Therapeutic Targets [Time frame: Beginning of study to end of study, up to 1 year.]
Secondary outcome measures (4)
- Survival [Time frame: Beginning of study up to age 21 or death, whichever comes first.]
- Progression Free Survival (PFS) [Time frame: Beginning of study up to age 21 or death, whichever comes first.]
- Visual Deficit Assessment [Time frame: At 6 and 12 months after the specimen sample was taken.]
- Pituitary Function Assessment [Time frame: At 6 and 12 months after the specimen sample was taken.]
Eligibility criteria
Inclusion criteria
- Patients between 0-21 years of age.
- Patients with the diagnosis or clinical suspicion of craniopharyngioma in whom planned clinical management will include tissue sampling.
Exclusion criteria
- Patients in whom final pathology does not demonstrate adamantinomatous craniopharyngioma
- Patients in whom tissue specimen is not obtained/available
- Patients over 21 years of age.
- Patients who choose not to participate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Children's Hospital Colorado — Aurora
Identifiers
NCT: NCT03610906 · 14-0426.cc