Broholm 2008.
Study characteristics | |||
Patient Sampling |
Inclusion/exclusion criteria NR. Quote: "46 patients were included in the study. The material consisted of 10 oligodendrogliomas (5 WHO Grade II (OII) and 5 Grade III (AOIII)), 10 mixed oligoastrocytomas (5 WHO Grade II (OAII) and 5 Grade III (AOAIII)), 10 astrocytomas (5 WHO Grade II (AII) and 5 Grade III (AAIII)) and 11 glioblastomas, WHO Grade IV (GBMIV)". Prior testing Histopathological diagnosis according to WHO 2000 classification. |
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Patient characteristics and setting |
Number of participants/tumours with results for 1p/19q status by ≥ 2 DNA‐based tests: 38 Country: Denmark Population source and setting: FFPE tissue from the Laboratory of Neuropathology, Rigshospitalet, Copenhagen, Denmark. Time period NR Age: NR Gender: NR Karnofsky performance status: NR First diagnosis/recurrent disease: NR |
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Index tests |
2 tests: FISH and PCR FISH Tumour sample type: FFPE Region(s) analysed: 1p36.33 and 19q13 (Vysis #40218 and #38967, Vysis, Des Plaines, Illinois, USA) Cut‐off: quote: "The FISH‐sum in % was calculated (amount of cells with only one or none fluorescence signal for the investigated probe in relation to the total cell count). The conclusion – loss (Pos.) or no loss (N) was noted. For 1p loss the FISH‐sum in % had to be higher than the calculated cut‐off level at 43.24% and for 19q more than 55.12%". PCR Tumour sample type: FFPE Region(s) analysed: D1S164 (1p34.4), D1S496 (1p34.4), D1S199 (1p36.1), D1S468 (1p36.3), D1S2736 (1p36.3); D19S867 (19q13.3), D19S888 (19q13.4), D19S572 (19q13.4), D19S210 (19q13.4) Cut‐off: allelic ratio < 0.5 or > 1.65 Additional details: PCR‐based LOH (microsatellite) without the need for comparison to normal DNA. References Hatanpaa 2003a. |
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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 | 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? | Unclear | ||
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? | Low concern | ||
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? | Unclear | ||
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? | Unclear | ||
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 |