Burger 2001.
| Study characteristics | |||
| Patient Sampling |
Inclusion/exclusion criteria NR. The study included 18 cases of classic and borderline examples of infiltrating gliomas of oligodendroglioma, mixed gliomas (oligoastrocytomas), fibrillary astrocytomas of varying grade, and difficult‐to‐classify intermediate lesions (note, 1 glioma was included in Hatanpaa 2003b and is extracted as part of that study). Prior testing Initial histopathological diagnosis, followed by review and diagnosis according to WHO 2000 classification (independent of the results of CGH, FISH and LOH microsatellite analysis). |
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| Patient characteristics and setting |
Number of participants/tumours with results for 1p/19q status by ≥ 2 DNA‐based tests: 17 Country: USA Population source and setting: NR Age: mean: 39.5 years, standard deviation: 12.7 years Gender: 41.2% male Karnofsky performance status: NR First diagnosis/recurrent disease: NR |
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| Index tests |
3 tests: CGH, FISH and PCR CGH Tumour sample type: FFPE (apart from 1 case, where fresh tissue was available) Region(s) analysed: genome wide Cut‐off: scored as loss if the relative loss < 0.8 FISH Tumour sample type: FFPE (apart from 1 case, where fresh tissue was available) Region(s) analysed: 1p36, 1q24, 19p13.1, 19q13.1‐q13.2, 19q13.3 Cut‐off: NR PCR Tumour sample type: FFPE (apart from 1 case, where fresh tissue was available) Region(s) analysed: 1p: D1S226, D1S312, D1S162, D1S186, D1S199, D1S243; 19p: D19S206, D19S412, D19S112, D19S197, D19S400, D19S422, D19S570 Cut‐off: NR. Overall results for 1p and 19q not given. We assumed that if results were homozygous or indeterminant at all loci examined that codeletion was present. |
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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? | No | ||
| 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? | Low 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) | |||
| 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 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 | ||