Prospective Pilot Study Identifying Clinically Relevant Biological Targets for Medical Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-12

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Craniopharyngioma, Child

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Tumor and Blood Specimens

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients between 0-21 years of age.
2. Patients with the diagnosis or clinical suspicion of craniopharyngioma in whom planned clinical management will include tissue sampling.

Exclusion Criteria

1. Patients in whom final pathology does not demonstrate adamantinomatous craniopharyngioma
2. Patients in whom tissue specimen is not obtained/available
3. Patients over 21 years of age.
4. Patients who choose not to participate

Minimum Eligible Age

30 Days

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No