Duval 2014.
| Study characteristics | |||
| Patient Sampling |
Inclusion/exclusion criteria Inclusion criteria: oligodendrogliomas with FFPE tissue with previously established 1p/19q status by FISH. Prior testing Histopathological diagnosis according to WHO 2007 classification. Previously established 1p/19q status by FISH. |
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| Patient characteristics and setting |
Number of participants/tumours with results for 1p/19q status by ≥ 2 DNA‐based tests: 36 Country: Canada Population source and setting: NR Age: median: 55 years, interquartile range: NR; range: 26–82 years Gender: 38.9% male Karnofsky performance status: NR First diagnosis/recurrent disease: 16.7% recurrent tumours |
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| Index tests |
4 tests: FISH (variant 1), FISH (variant 2), FISH (variant 3) and FISH (variant 4) FISH (variant 1) Tumour sample type: FFPE Region(s) analysed: 1p36/19q13 Dual‐Color Probe kit (Abbott Molecular, Abbott Park, Illinois, USA) Cut‐off: combination cut‐off: quote: "The cut‐off of nuclei that had to show deletion was calculated on a series of 10 non‐neoplastic brain tissue samples (from epilepsy surgery cases and autopsy brains). This cut‐off was calculated using mean +3 SD and was set at 50% for both 1p and 19q. Cases above the cutoff were considered deleted and those under the cut‐off were considered normal or imbalanced according to the literature guidelines [43,44]". FISH (variant 2) Tumour sample type: FFPE Region(s) analysed: 1p36/19q13 Dual‐Color Probe kit (Abbott Molecular, Abbott Park, Illinois, USA) Cut‐off: ratio cut‐off: ratio ≤ 0.8 was considered to indicate a deletion; quote: "For each case the signal ratio of red signals to green signals per cell was also established. A ratio ≤0.8 was considered to indicate a deletion whereas a ratio between 0.8 and 1.1 was considered to indicate a normal status on the chromosomal arm. A ratio over 1.1 was considered to indicate polysomy and was classified in the imbalanced status subgroup [2,30]". FISH (variant 3) Tumour sample type: FFPE Region(s) analysed: 1p36/19q13 Dual‐Color Probe kit (Abbott Molecular, Abbott Park, Illinois, USA) Cut‐off: combination cut‐off: quote: "cut‐off at the median value of our tumor series which corresponds to a value of 65% for both 1p and 19q". Additional details: ImmunoFISH. IHC performed against Ki67 (MIB‐1). FISH (variant 4) Tumour sample type: FFPE Region(s) analysed: 1p36/19q13 Dual‐Color Probe kit (Abbott Molecular, Abbott Park, Illinois, USA) Cut‐off: ratio cut‐off: ratio ≤ 0.8 was considered to indicate a deletion; quote: "For the ratio method, established values were the same as for the FISH". Additional details: ImmunoFISH. IHC performed against Ki67 (MIB‐1). |
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| Target condition and reference standard(s) | Target condition was absolute 1p/19q deletion. No tests used as reference standard in 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? | No | ||
| Was a case‐control design avoided? | Yes | ||
| Did the study avoid inappropriate exclusions? | Unclear | ||
| Could the selection of patients have introduced bias? | High 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)) | |||
| 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 (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) | |||
| DOMAIN 2: Index Test (NGS or aCGH (or both)) | |||
| DOMAIN 2: Index Test (Methylation array) | |||
| DOMAIN 2: Index Test (FISH) | |||
| DOMAIN 2: Index Test (FISH (variant 1)) | |||
| 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 2)) | |||
| 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 3)) | |||
| 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 (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? | Yes | ||
| Could the patient flow have introduced bias? | Low risk | ||