TriangleNCT00007345 · OUTCOME
Fold Change in Histone Acetylation
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Fold change
- Interval / dispersion
- Full Range
- Time frame
- 4 hours, 24 hours, and 48 hours after Romidepsin
What was measured
Fold change is calculated by dividing the level of histone acetylation in a treated sample (at 4, 24, and 48 hours) measured as intensity on a dot blot immunoassay, divided by the intensity in the pre-treatment sample. We considered a ≥ 2-fold change a measurable difference, and indicative of successful HDAC inhibition by romidepsin (depsipeptide).
Analysis population: Global histone acetylation of all samples at pretreatment was designated as 1; values at other time points for each patient were calculated relative to the corresponding pretreatment value.
Groups in this outcome
Peripheral T-cell Lymphoma (PTCL)
Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
Cutaneous T-cell Lymphoma (CTCL)
Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
| Group | Source count |
|---|---|
| Peripheral T-cell Lymphoma (PTCL) | 18 |
| Cutaneous T-cell Lymphoma (CTCL) | 29 |
Reported measurements
4 hours
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | 2.99 | Not reported | 0.53 | 11.03 | Not reported |
| Cutaneous T-cell Lymphoma (CTCL) | 3.00 | Not reported | 0.44 | 17.30 | Not reported |
24 hours
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | 1.97 | Not reported | 0.67 | 6.71 | Not reported |
| Cutaneous T-cell Lymphoma (CTCL) | 1.78 | Not reported | 0.037 | 17.45 | Not reported |
48 hours
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | 0.62 | Not reported | 0.22 | 1.02 | Not reported |
| Cutaneous T-cell Lymphoma (CTCL) | 1.67 | Not reported | 0.28 | 17.64 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.53
- upper Limit
- 11.03
- value
- 2.99
- group Id
- OG001
- lower Limit
- 0.44
- upper Limit
- 17.30
- value
- 3.00
- title
- 4 hours
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.67
- upper Limit
- 6.71
- value
- 1.97
- group Id
- OG001
- lower Limit
- 0.037
- upper Limit
- 17.45
- value
- 1.78
- title
- 24 hours
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.22
- upper Limit
- 1.02
- value
- 0.62
- group Id
- OG001
- lower Limit
- 0.28
- upper Limit
- 17.64
- value
- 1.67
- title
- 48 hours
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 29
- units
- Participants
- description
- Fold change is calculated by dividing the level of histone acetylation in a treated sample (at 4, 24, and 48 hours) measured as intensity on a dot blot immunoassay, divided by the intensity in the pre-treatment sample. We considered a ≥ 2-fold change a measurable difference, and indicative of successful HDAC inhibition by romidepsin (depsipeptide).
- dispersion Type
- Full Range
- groups
- description
- Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
- id
- OG000
- title
- Peripheral T-cell Lymphoma (PTCL)
- description
- Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
- id
- OG001
- title
- Cutaneous T-cell Lymphoma (CTCL)
- param Type
- MEDIAN
- population Description
- Global histone acetylation of all samples at pretreatment was designated as 1; values at other time points for each patient were calculated relative to the corresponding pretreatment value.
- reporting Status
- POSTED
- time Frame
- 4 hours, 24 hours, and 48 hours after Romidepsin
- title
- Fold Change in Histone Acetylation
- type
- SECONDARY
- unit Of Measure
- Fold change
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice