This is an example showing trial design and results from the in vitro bacterial reverse mutation test of Study #8325064.
The bacterial reverse mutation test uses amino acid-requiring strains of Salmonella typhimurium (S. typhimurium) and Escherichia coli (E. coli) to detect point mutations, which involve substitution, addition or deletion of one or a few DNA base pairs. The principle of this bacterial reverse mutation test is that it detects chemicals that induce mutations which revert mutations present in the tester strains and restore the functional capability of the bacteria to synthesize an essential amino acid. The revertant bacteria are detected by their ability to grow in the absence of the amino acid required by the parent tester strain.
- red font - indicates potential for CT code lists
- green font - links to other domains
- purple font - to be discussed
- During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled; For now, we just include good example values based on our experience
- Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations as specified in the trial design.
- Do we need "plate counted manually"
- How do we handle "toxic, no revertant colonies"?
- Condition of background bacterial lawn? Slight thinning, Very thin??
| Row | STUDYID | ASSAYID | DOMAIN | SETCD | SET (what sponsor calls it) | TXSEQ | TXPARMCD | TXPARM | TXVAL |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 8325064 | Ames | TX | SetA (Row 1) | METACT | Metabolic Activation (should there be two parms? Presence, type)? | None | ||
| 8325064 | Ames | TX | SetA | TRTDRTRG | Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable) | ||||
| 3 | 8325064 | Ames | TX | SetA | TRTDRTOL | Treatment Duration Tolerance | |||
| 4 | 8325064 | Ames | TX | SetA | TRTDURU | Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL) | |||
| 5 | 8325064 | Ames | TX | SetA | INTRVN | name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A) | DMSO. (or TA1) | ||
| 6 | 8325064 | Ames | TX | SetA | ITVTYPE | type of intervention article choices of values: product; negative control; positive control | Vehicle Control. (or Product) | ||
| 7 | 8325064 | Ames | TX | SetA | ITVCONC | Concentration of intervention article | 0 (null?) | ||
| 8 | 8325064 | Ames | TX | SetA | ITVCONCU | Concentration Unit | ug/plate | ||
| 9 | 8325064 | Ames | TX | SetA | STRAIN | Strain/Substrain | TA98 | ||
| 10 | 8325064 | Ames | TX | SetA | REGIME | Smoking Regime | ISO | ||
|
| ||||||||
| ... | |||||||||
| 8325064 | Ames | TX | SetF (row 4) | METACT | Metabolic Activation (should there be two parms? Presence, type)? | None | |||
| 8325064 | Ames | TX | SetF | TRTDRTRG | Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable) | ||||
| 8325064 | Ames | TX | SetF | TRTDRTOL | Treatment Duration Tolerance | ||||
| 8325064 | Ames | TX | SetF | TRTDURU | Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL) | ||||
| 8325064 | Ames | TX | SetF | INTRVN | name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A) | 2-Nitrofluorine | |||
| 8325064 | Ames | TX | SetF | ITVTYPE | type of intervention article choices of values: product; negative control; positive control | Positive Control | |||
| 8325064 | Ames | TX | SetF | ITVCONC | Concentration of intervention article | 5 | |||
| 8325064 | Ames | TX | SetF | ITVCONCU | Concentration Unit | ug/plate | |||
| 8325064 | Ames | TX | SetF | STRAIN | Strain/Substrain | TA98 | |||
| 8325064 | Ames | TX | SetF | REGIME | Smoking Regime | ISO | |||
| 8325064 | Ames | TX | SetF | ARTCON | Concentration level of intervention article on plate | 500 | |||
| 8325064 | Ames | TX | SetF | CONUNIT | Concentration level of intervention article on plate, unit | ug/plate | |||
| ... | |||||||||
| 8325064 | Ames | TX | SetI(row 6) | METACT | Metabolic Activation (should there be two parms? Presence, type)? | None | |||
| 8325064 | Ames | TX | SetI | TRTDRTRG | Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable) | ||||
| 8325064 | Ames | TX | SetI | TRTDRTOL | Treatment Duration Tolerance | ||||
| 8325064 | Ames | TX | SetI | TRTDURU | Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL) | ||||
| 8325064 | Ames | TX | SetI | INTRVN | name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A) | 2-Nitrofluorine | |||
| 8325064 | Ames | TX | SetI | ITVTYPE | type of intervention article choices of values: product; negative control; positive control | Positive Control | |||
| 8325064 | Ames | TX | SetI | ITVCONC | Concentration of intervention article | 5 | |||
| 8325064 | Ames | TX | SetI | ITVCONCU | Concentration Unit | ug/plate | |||
| 8325064 | Ames | TX | SetI | STRAIN | Strain/Substrain | TA98 | |||
| 8325064 | Ames | TX | SetI | REGIME | Smoking Regime | ISO | |||
| ... | |||||||||
| 8325064 | Ames | TX | SetR (Row 18) | METACT | Metabolic Activation (should there be two parms? Presence, type)? | None | |||
| 8325064 | Ames | TX | SetR | TRTDRTRG | Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable) | ||||
| 8325064 | Ames | TX | SetR | TRTDRTOL | Treatment Duration Tolerance | ||||
| 8325064 | Ames | TX | SetR | TRTDURU | Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL) | ||||
| 8325064 | Ames | TX | SetR | INTRVN | name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A) | 4-Nitroquinoline-1-oxide | |||
| 8325064 | Ames | TX | SetR | ITVTYPE | type of intervention article choices of values: product; negative control; positive control | Positive Control | |||
| 8325064 | Ames | TX | SetR | ITVCONC | Concentration of intervention article | 2 | |||
| 8325064 | Ames | TX | SetR | ITVCONCU | Concentration Unit | ug/plate | |||
| 8325064 | Ames | TX | SetR | STRAIN | Strain/Substrain | TA98 | |||
| 8325064 | Ames | TX | SetR | REGIME | Smoking Regime | ISO | |||
| ... | |||||||||
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