Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT01014767
Eligibility Criteria:
Inclusion Criteria:
1. Histological diagnosis of a choroid plexus tumor by a local pathologist/neuropathologist. This includes choroid plexus papilloma, atypical choroid plexus papilloma, anaplastic choroid plexus papilloma, malignant choroid plexus papilloma, and choroid plexus carcinoma.
2. Slides have been sent to the pathology reference center (by declaration of the sending center).
3. Informed consent signed
4. The first registration on the study was completed or was sent with the same mail or fax or electronic registration.
5. The reference center has confirmed the receipt of slides sent.
6. The postoperative imaging has been done and the result is available.
7. Disease status and histology: The patient is suffering from either choroid plexus carcinoma of any stage, OR an atypical choroid plexus papilloma with tumor residual after maximal possible surgical resection, OR a primary metastatic atypical choroid plexus papilloma. OR a first recurring choroid plexus papilloma that is either not resectable or was metastatic, OR a second recurrence of any choroid plexus tumor.
8. The agreement of patient or legal guardian has been documented according to the local guidelines.
9. For females in reproductive age: pregnancy test negative (both urine or blood test acceptable)
10. Females in reproductive age, patients must agree to use a medically accepted method of contraception while receiving protocol-specified medication.
Exclusion Criteria:
1. Previous chemotherapy
2. Previous radiation therapy of the central nervous system
3. White blood cell count \< 2000/ uL
4. Platelet count \< 85 000 / uL
5. Inadequate kidney function with Creatinine \> age adapted upper normal range AND creatinine clearance or GFR determined by nuclear medicine \< 70 ml/min/1.73 m2 Body surface area
6. Hearing loss more than 30 dB at 3000 Hz or more than 40 dB at 4000 Hz.
7. Echocardiography indicates myocardial dysfunction or weakness
8. Patients who are involuntarily hospitalized because of mental illness
9. Pregnancy
10. ALT or AST elevated higher than three times the upper normal level.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01014767
Study Brief:
Protocol Section:
NCT01014767