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New data suggests that the current treatment for pediatric adamantinomatous craniopharyngioma (CPA) may not be as effective as it could be.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatrics with Tumors | Pediatrics who have a tumor specimen that is suspected to be craniopharyngioma, but is deemed superfluous to the clinical care of the patient (e.g. pathological diagnosis). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor and Blood Specimens | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of Potential Therapeutic Targets | Investigators will identify potential therapeutic targets through mRNA expression. | Beginning of study to end of study, up to 1 year. |
| Identification of Potential Therapeutic Targets | Investigators will identify potential therapeutic targets through microarray analysis. | Beginning of study to end of study, up to 1 year. |
| Identification of Potential Therapeutic Targets | Investigators will identify potential therapeutic targets immunohistochemistry. | Beginning of study to end of study, up to 1 year. |
| Identification of Potential Therapeutic Targets | Investigators will identify potential therapeutic targets through quantitative PCR. | Beginning of study to end of study, up to 1 year. |
| Identification of Potential Therapeutic Targets | Investigators will also perform immunostaining for beta-catenin and use DNA SNaPshot analysis to determine what parts of the tumor are responsible for observed gene signatures. | Beginning of study to end of study, up to 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | The amount of time the patient survives with or without the disease. | Beginning of study up to age 21 or death, whichever comes first. |
| Progression Free Survival (PFS) | The amount of time the patient survives without advancement of disease. |
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Inclusion Criteria:
Exclusion Criteria:
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The population to be enrolled in this study will be children ages 0 through 21 years of age with a high preoperative suspicion of craniopharyngioma. The study population will be selected from the clinics at the 10 POETIC member institutions, and selected additional institutions by the treating clinicians.
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| Name | Affiliation | Role |
|---|---|---|
| Todd Hankinson, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D003397 | Craniopharyngioma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D047368 | Tumor Burden |
| ID | Term |
|---|---|
| D001837 | Body Weights and Measures |
| D000886 | Anthropometry |
| D008919 | Investigative Techniques |
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Brain tissue and/or cyst fluid, blood
|
| Beginning of study up to age 21 or death, whichever comes first. |
| Visual Deficit Assessment | With regard to visual deficits, investigators will compare the rates of functional blindness, unilateral blindness, and visual field deficit. | At 6 and 12 months after the specimen sample was taken. |
| Pituitary Function Assessment | With regard to pituitary function, investigators will assess patients based on the quality of life impairment that is associated with their dysfunction. Assessment will be divided among 4 groups:
| At 6 and 12 months after the specimen sample was taken. |