Scheie 2006.
| Study characteristics | |||
| Patient Sampling |
Inclusion/exclusion criteria Inclusion criteria: people with a supratentorial oligodendroglial tumour 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: 40 Country: Norway Population source and setting: Rikshospitalet‐Radiumhospitalet Medical Center (Oslo, Norway). 2000–2004. Age: mean: 43.1 years, standard deviation: NR; range: 19–66 years Gender: NR Karnofsky performance status: NR First diagnosis/recurrent disease: 95% first diagnosis (38/40); 5% recurrent disease (2/40) |
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| Index tests |
2 tests: FISH and PCR FISH Tumour sample type: fresh or fresh‐frozen Region(s) analysed: 1p36.3 (D1Z2)/D1Z hybridising to the pericentric region (Q‐biogene, Heidelberg, Germany), 19q (D19S238E)/telomeric region on chromosome 19p (Vysis Inc, Downers Grove, Illinois, USA). Cut‐off: a tumour was defined as FISH positive when FISH‐sum (proportion of cells with FISH‐LOH and FISH‐imbalance) exceeded the mean plus 3 standard deviations value in control specimens from non‐neoplastic brain tissue. The presence of 0 or 1 1p36‐ or 19q‐ signal was reported as FISH‐LOH. Losses with any disproportion (signal ratios 3/2, 4/3, 4/2, 5/3, etc. were defined as FISH‐imbalance. Cut‐offs: 27.7% for 1p and 33.2% for 19q Additional details: FISH on touch preparations PCR Tumour sample type: fresh‐frozen or FFPE Region(s) analysed: ≥ 4 of the following for chromosome 1 and 19: chromosome 1: D1S2660, D1S507, D1S199, D1S2734, D1S1676, D1S247; chromosome 19: D19S918, D19S219, D19S112, D19S412, D19S596, D19S206 Cut‐off: results were defined as LOH‐positive when the peak areas of fluorescent intensity curves, corresponding to PCR products from individual primer sets, showed a relative reduction of ≥ 40% when the products from tumour DNA were compared with those from normal DNA. Unclear how many markers had to display 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 both tests were performed on the same sample for each participant. | ||
| 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? | Yes | ||
| Could the patient flow have introduced bias? | Low risk | ||