NCT00602667 · OUTCOME
Number of Participants With Endocrinopathy
Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma · Source last updated 2026-05-19
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- End of induction therapy (approximately 16 weeks from start of treatment), end of therapy (approximately 48 weeks from start of treatment), and 6, 12, 24, 36, 48, and 60 months off therapy
What was measured
Endocrine screening and growth hormone (GH) testing were done in consenting intermediate risk patients at the end of induction therapy, the end of all therapy, and at 6, 12, 24, 36, 48, and 60 months off therapy. Endocrinopathy was defined as the presence of central hypothyroidism (free T4 concentration below normal with low or normal TSH concentration), growth hormone deficiency (peak growth hormone concentration below 5 ng/mL on dynamic testing), or ACTH deficiency (cortisol concentration below 14 ug/dL after low dose cosyntropin stimulation). Numbers of participants with endocrinopathy at each time point are reported. Please note the small numbers of participants with available data.
Analysis population: Endocrine screening and growth hormone (GH) testing were done in consenting intermediate risk patients.
Groups in this outcome
Low-Risk Group
Patients with gross total resection (GTR)/no evidence of metastatic (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.
Intermediate-Risk Group
Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.
High-Risk Group
Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Low-Risk Group | 0 |
|---|
| Intermediate-Risk Group | 24 |
|---|
| High-Risk Group | 0 |
|---|
Reported measurements
End of induction-number with endocrinopathy
Analysis denominator · Participants
| Group | Source count |
|---|
| Low-Risk Group | 0 |
|---|
| Intermediate-Risk Group | 13 |
|---|
| High-Risk Group | 0 |
|---|
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Intermediate-Risk Group | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
End of therapy-number with endocrinopathy
Analysis denominator · Participants
| Group | Source count |
|---|
| Low-Risk Group | 0 |
|---|
| Intermediate-Risk Group | 8 |
|---|
| High-Risk Group | 0 |
|---|
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Intermediate-Risk Group | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
6-months off therapy-number with endocrinopathy
Analysis denominator · Participants
| Group | Source count |
|---|
| Low-Risk Group | 0 |
|---|
| Intermediate-Risk Group | 3 |
|---|
| High-Risk Group | 0 |
|---|
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Intermediate-Risk Group | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
12-months off therapy-number with endocrinopathy
Analysis denominator · Participants
| Group | Source count |
|---|
| Low-Risk Group | 0 |
|---|
| Intermediate-Risk Group | 1 |
|---|
| High-Risk Group | 0 |
|---|
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Intermediate-Risk Group | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
24-months off therapy-number with endocrinopathy
Analysis denominator · Participants
| Group | Source count |
|---|
| Low-Risk Group | 0 |
|---|
| Intermediate-Risk Group | 6 |
|---|
| High-Risk Group | 0 |
|---|
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Intermediate-Risk Group | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
36-months off therapy-number with endocrinopathy
Analysis denominator · Participants
| Group | Source count |
|---|
| Low-Risk Group | 0 |
|---|
| Intermediate-Risk Group | 1 |
|---|
| High-Risk Group | 0 |
|---|
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Intermediate-Risk Group | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
48-months off therapy-number with endocrinopathy
Analysis denominator · Participants
| Group | Source count |
|---|
| Low-Risk Group | 0 |
|---|
| Intermediate-Risk Group | 1 |
|---|
| High-Risk Group | 0 |
|---|
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Intermediate-Risk Group | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
60-months off therapy-number with endocrinopathy
Analysis denominator · Participants
| Group | Source count |
|---|
| Low-Risk Group | 0 |
|---|
| Intermediate-Risk Group | 1 |
|---|
| High-Risk Group | 0 |
|---|
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Intermediate-Risk Group | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- End of induction-number with endocrinopathy
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- End of therapy-number with endocrinopathy
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- 6-months off therapy-number with endocrinopathy
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- 12-months off therapy-number with endocrinopathy
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- 24-months off therapy-number with endocrinopathy
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- 36-months off therapy-number with endocrinopathy
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- 48-months off therapy-number with endocrinopathy
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- 60-months off therapy-number with endocrinopathy
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- Endocrine screening and growth hormone (GH) testing were done in consenting intermediate risk patients at the end of induction therapy, the end of all therapy, and at 6, 12, 24, 36, 48, and 60 months off therapy. Endocrinopathy was defined as the presence of central hypothyroidism (free T4 concentration below normal with low or normal TSH concentration), growth hormone deficiency (peak growth hormone concentration below 5 ng/mL on dynamic testing), or ACTH deficiency (cortisol concentration below 14 ug/dL after low dose cosyntropin stimulation). Numbers of participants with endocrinopathy at each time point are reported. Please note the small numbers of participants with available data.
- groups
- description
- Patients with gross total resection (GTR)/no evidence of metastatic (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.
- id
- OG000
- title
- Low-Risk Group
- description
- Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.
- id
- OG001
- title
- Intermediate-Risk Group
- description
- Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.
- id
- OG002
- title
- High-Risk Group
- param Type
- NUMBER
- population Description
- Endocrine screening and growth hormone (GH) testing were done in consenting intermediate risk patients.
- reporting Status
- POSTED
- time Frame
- End of induction therapy (approximately 16 weeks from start of treatment), end of therapy (approximately 48 weeks from start of treatment), and 6, 12, 24, 36, 48, and 60 months off therapy
- title
- Number of Participants With Endocrinopathy
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice