TriangleNCT00007345 · OUTCOME
Multidrug Resistance Protein 1 (MDR1) or ATP-binding Cassette Sub-family B Member 1 (ABCB1) Gene Expression
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
Total ribonucleic acid (RNA) was isolated from peripheral blood mononuclear cells or patient tissue biopsies and analyzed by quantitative polymerase chain reaction (qPCR). Expression of MDR-1/ABCB1 was determined by qPCR relative to an RNA standard, then normalized to ribosomal RNA (rRNA). Fold change is calculated by dividing the level of MDR-1 in a treated sample (at 4, 24, and 48 hours) measured by qPCR, divided by MDR-1 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: ABCB1 expression 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) | 17 |
| Cutaneous T-cell Lymphoma (CTCL) | 35 |
Reported measurements
4 hours
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | 2.74 | Not reported | 1.62 | 5.50 | Not reported |
| Cutaneous T-cell Lymphoma (CTCL) | 1.78 | Not reported | 0.19 | 21.08 | Not reported |
24 hours
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | 1.5 | Not reported | 0.053 | 3.4 | Not reported |
| Cutaneous T-cell Lymphoma (CTCL) | 1.53 | Not reported | 0.15 | 7.55 | Not reported |
48 hours
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | 0.545 | Not reported | 0.53 | 0.56 | Not reported |
| Cutaneous T-cell Lymphoma (CTCL) | 1.205 | Not reported | 0.15 | 19.42 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.62
- upper Limit
- 5.50
- value
- 2.74
- group Id
- OG001
- lower Limit
- 0.19
- upper Limit
- 21.08
- value
- 1.78
- title
- 4 hours
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.053
- upper Limit
- 3.4
- value
- 1.5
- group Id
- OG001
- lower Limit
- 0.15
- upper Limit
- 7.55
- value
- 1.53
- title
- 24 hours
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.53
- upper Limit
- 0.56
- value
- 0.545
- group Id
- OG001
- lower Limit
- 0.15
- upper Limit
- 19.42
- value
- 1.205
- title
- 48 hours
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 35
- units
- Participants
- description
- Total ribonucleic acid (RNA) was isolated from peripheral blood mononuclear cells or patient tissue biopsies and analyzed by quantitative polymerase chain reaction (qPCR). Expression of MDR-1/ABCB1 was determined by qPCR relative to an RNA standard, then normalized to ribosomal RNA (rRNA). Fold change is calculated by dividing the level of MDR-1 in a treated sample (at 4, 24, and 48 hours) measured by qPCR, divided by MDR-1 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
- ABCB1 expression 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
- Multidrug Resistance Protein 1 (MDR1) or ATP-binding Cassette Sub-family B Member 1 (ABCB1) Gene Expression
- type
- SECONDARY
- unit Of Measure
- Fold change
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice