Clark 2013.
Study characteristics | |||
Patient Sampling |
Inclusion/exclusion criteria Inclusion criteria: glioblastoma cases in the Hillman Cancer registry. Exclusion criteria: cases of recurrent or treated (or both) glioma. Prior testing Histopathological diagnosis (WHO 2007 classification). |
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Patient characteristics and setting |
Number of participants/tumours with results for 1p/19q status by ≥ 2 DNA‐based tests: 446 Country: USA Population source and setting: Hillman Cancer Registry, University of Pittsburgh, USA. 2002–2010 Agea: median: 63 years, interquartile range: NR; range: 18–89 years Gendera: 58.5% male Karnofsky performance status: NR First diagnosis/recurrent disease: 100% first diagnosis. Cases of recurrent glioma were excluded. aFor whole population: there were 532 cases in the complete glioblastoma cohort, 491 had upfront 1p/19q testing, 446 had results for both tests. |
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Index tests |
2 tests: FISH and PCR FISH Tumour sample type: FFPE Region(s) analysed: 1p36/1q25, 19q13/19p36 (Abbott Molecular, Des Plaines, Illinois, USA). Cut‐off: quote: "Codeletion was counted if the 1p36/1q25 and 19q13/19p13 ratios were both below 0.87 and at least 20% of tumour nuclei showed relative deletion". PCR Tumour sample type: FFPE Region(s) analysed: D1S1172, D1S226, D1S162, D1S1161, D1S199, D1S407, D1S171, D19S112, D19S206, D19S559 (from 2007 onwards, comprising 75% of the total cohort) Cut‐off: quote: "To be considered codeleted the majority of informative microsatellite loci on both 1p and 19q had to show LOH". |
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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. |
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Flow and timing | We presumed that all tests were performed on biopsied tumour material collected on 1 occasion. | ||
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? | High | ||
DOMAIN 2: Index Test (NanoString) | |||
DOMAIN 2: Index Test (aCGH) | |||
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? | Yes | ||
Were the index test results interpreted without knowledge of the results of the other tests being compared? | Unclear | ||
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? | Unclear | ||
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 (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 |