Mohapatra 2006.
Study characteristics | |||
Patient Sampling |
Inclusion/exclusion criteria Not explicitly reported, but all glioma samples had oligodendroglial features on histopathological examination. Prior testing Not explicitly reported, but presumably histopathological diagnosis. |
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Patient characteristics and setting |
Number of participants/tumours with results for 1p/19q status by ≥ 2 DNA‐based tests: 28 Country: USA Population source and setting: Massachusetts General Hospital. 1999–2004 Age: NR Gender: NR Karnofsky performance status: NR First diagnosis/recurrent disease: NR |
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Index tests |
3 tests: aCGH, FISH and PCR aCGH Tumour sample type: FFPE Region(s) analysed: not explicitly reported but 100 BACs (bacterial artificial chromosome) over chromosome 1, 50 BACs over chromosome 19 Cut‐off: quote: "Segments were considered to represent true losses or gains according to whether their associated absolute mean log2 ratio levels were greater than (2 × σ/√n) With σ estimated to be 0.58, the empirical estimate of the SD of the standardized segment means for 1q, and n equal to the number of clones in the given segment. For example, a 19q segment that contains 26 clones was considered to represent loss if its estimated mean level was less than −0.23. A 1p segment that contains 57 clones was considered to represent loss if its estimated mean level was less than −0.16. A 1p segment that contains 30 clones was considered to represent loss if its estimated mean level was less than −0.22". Additional details: a BAC array was constructed containing 200 targets that represented chromosomes 1, 7, 19, and X. FISH Tumour sample type: FFPE Region(s) analysed: 1p36.2/1q21, 19q13.3/19p13.3 Cut‐off: quote: "Relative copy numbers for 1p/1q and 19q/19p were counted, and a ratio of 0.7 or less for 1p:1q and/or 19q:19p was considered a loss". PCR Tumour sample type: FFPE Region(s) analysed: 1p: D1S508, D1S199, D1S2734; 19q: D19S219, D19S112, D19S412. Cut‐off: NR |
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Target condition and reference standard(s) | Target condition was absolute 1p/19q deletion. FISH or PCR‐based LOH used as reference standard in some of our analyses. | ||
Flow and timing | All tests were performed on the same FFPE tissue. | ||
Comparative | |||
Notes | |||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | Unclear | ||
Was a case‐control design avoided? | Yes | ||
Did the study avoid inappropriate exclusions? | Yes | ||
Could the selection of patients have introduced bias? | Unclear risk | ||
Are there concerns that the included patients and setting do not match the review question? | Unclear | ||
DOMAIN 2: Index Test (NanoString) | |||
DOMAIN 2: Index Test (aCGH) | |||
If a threshold was used, was it pre‐specified? | Yes | ||
Were the index test results interpreted without knowledge of the results of the other tests being compared? | Yes | ||
Could the conduct or interpretation of the index test have introduced bias? | Low risk | ||
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
DOMAIN 2: Index Test (NGS) | |||
DOMAIN 2: Index Test (G‐banding) | |||
DOMAIN 2: Index Test (FISH (variant 4)) | |||
DOMAIN 2: Index Test (SNP array) | |||
DOMAIN 2: Index Test (PCR (with comparison to normal DNA)) | |||
DOMAIN 2: Index Test (PCR (without comparison to normal DNA)) | |||
DOMAIN 2: Index Test (CISH) | |||
DOMAIN 2: Index Test (MS) | |||
DOMAIN 2: Index Test (RFLP) | |||
DOMAIN 2: Index Test (PCR‐based LOH) | |||
If a threshold was used, was it pre‐specified? | Unclear | ||
Were the index test results interpreted without knowledge of the results of the other tests being compared? | Yes | ||
Could the conduct or interpretation of the index test have introduced bias? | Unclear risk | ||
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
DOMAIN 2: Index Test (NGS or aCGH (or both)) | |||
DOMAIN 2: Index Test (Methylation array) | |||
DOMAIN 2: Index Test (FISH) | |||
If a threshold was used, was it pre‐specified? | Yes | ||
Were the index test results interpreted without knowledge of the results of the other tests being compared? | Yes | ||
Could the conduct or interpretation of the index test have introduced bias? | Low risk | ||
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
DOMAIN 2: Index Test (FISH (variant 1)) | |||
DOMAIN 2: Index Test (FISH (variant 2)) | |||
DOMAIN 2: Index Test (FISH (variant 3)) | |||
DOMAIN 2: Index Test (Real‐time PCR) | |||
DOMAIN 2: Index Test (MLPA) | |||
DOMAIN 2: Index Test (CGH) | |||
DOMAIN 3: Reference Standard | |||
Is the reference standards likely to correctly classify the target condition? | No | ||
Could the reference standard, its conduct, or its interpretation have introduced bias? | High risk | ||
Are there concerns that the target condition as defined by the reference standard does not match the question? | Low concern | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | Yes | ||
Were all patients included in the analysis? | No | ||
Could the patient flow have introduced bias? | High risk |