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. 2022 Mar 2;2022(3):CD013387. doi: 10.1002/14651858.CD013387.pub2

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.
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.
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".
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