Gadji 2009.
Study characteristics | |||
Patient Sampling |
Inclusion/exclusion criteria Inclusion criteria: initially diagnosed oligodendroglial or oligoastrocytomal brain tumour Prior testing Histopathological diagnosis: tumours were reviewed and classified according to the 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: 11 Country: Canada Population source and setting: Sherbrooke University hospital, Canada. 1993–2007 Age: mean: 38.8 years, standard deviation: 8.3 years Gender*: 35.1% male Karnofsky performance status: NR First diagnosis/recurrent disease: NR *For whole population: 37 participants were included, but only 11 had both tests. |
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Index tests |
2 tests: FISH and PCR FISH Tumour sample type: FFPE or fresh (touch‐preparation smear) Region(s) analysed: 1p36/1q25, 19p13/19q13 (Vysis LSI; Abbott Molecular, Des Plaines, Illinois, USA) Cut‐off: quote: "A case was considered deleted with 1p, 19q, or both when the scored nuclei displayed an imbalance between green and red signals". PCR Tumour sample type: NR Region(s) analysed: chromosome 1 (8 test markers on the short arm and 2 control markers on the long arm): D1S2795 (1p36.31), D1S2666 (1p36.23), D1S244 (1p36.22), D1S2676 (1p34.3), D1S2729 (1p34.3), D1S2722 (1p34.2), D1S508 (1p36.31~p36.21), D1S2734 (1p35.36), D1S252 (1q21), D1S2346 (1q22); chromosome 19 (9 test markers on the long arm and 1 control marker on the short arm): D19S412 (19q13.32), D19S559 (19q13.32), D19S200 (19q13.2), D19S397 (19q13.14), D19S422 (19q13.13), D19S425 (19q13.12), D19S416 (19q13.11), D19S112 (19q13.3), D19S556 (19p13.13). All markers were obtained from IDT (Coralville, Iowa, USA). Cut‐off: quote: "An absence or a significant reduction in intensity of >50% in the tumor lane compared with the corresponding blood and saliva lanes was scored as 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. | ||
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? | Yes | ||
Was a case‐control design avoided? | Yes | ||
Did the study avoid inappropriate exclusions? | Yes | ||
Could the selection of patients have introduced bias? | Low 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? | 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? | 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 (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? | Unclear | ||
Could the patient flow have introduced bias? | Unclear risk |