Duval 2015.
| Study characteristics | |||
| Patient Sampling |
Inclusion/exclusion criteria NR Prior testing Not explicitly reported but presumably histopathological diagnosis |
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| Patient characteristics and setting |
Number of participants/tumours with results for 1p/19q status by ≥ 2 DNA‐based tests: 29 Country: France Population source and setting: Centre Hospitalier Universitaire de Rennes (France). 2010–2015 Age: NR Gender: NR Karnofsky performance status: NR First diagnosis/recurrent disease: NR |
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| Index tests |
2 tests: FISH (variant 1) and FISH (variant 2) FISH (variant 1) Tumour sample type: FFPE Region(s) analysed: 1p36/1q25 and 19q13/19p13 (Dual Color Probe kit, Abbott Molecular, Abbott Park, Illinois, USA). Cut‐off: combination + ratio method. Cases deleted in 1 method and normal in the other were considered deleted. Combination method: deletion status combinations (for 1p and 19q, control/test): 2/0, 2/1, 3/0, 3/1, 4/1, 4/2, 5/2, 6/2, 6/3. Normal status combinations 2/2, 1/2. (Imbalance status combinations 1/3, 1/4, 2/3, 2/4, 2/5, 3/3, 3/4, 4/3, 4/4, 4/5, 5/4, 5/5, 5/6.) The cut‐off value for the number of nuclei that had to show deletion was 55% for both 1p and 19q for deletion status (and 20% for imbalance status). Ratio method: the signal ratio of test:control probes ≤ 0.8 was considered to indicate a deletion. Additional details: automated analysis using the Metafer 4 software (Metasystem) using the "1p19q tile‐sampling classifier". FISH (variant 2) Tumour sample type: FFPE Region(s) analysed: 1p36/1q25 and 19q13/19p13 (Dual Color Probe kit, Abbott Molecular, Abbott Park, Illinois, USA). Cut‐off: combination + ratio method. Cases deleted in 1 method and normal in the other were considered deleted. Combination method: deletion status combinations (for 1p and 19q, control/test): 2/0, 2/1, 3/0, 3/1, 4/1, 4/2, 5/2, 6/2, 6/3. Normal status combinations 2/2, 1/2. (Imbalance status combinations 1/3, 1/4, 2/3, 2/4, 2/5, 3/3, 3/4, 4/3, 4/4, 4/5, 5/4, 5/5, 5/6.) The cut‐off value for the number of nuclei that had to show deletion was 55% for both 1p and 19q for deletion status (and 20% for imbalance status). Ratio method: the signal ratio of test:control probes ≤ 0.8 was considered to indicate a deletion. Additional details: manual analysis |
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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? | 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) | |||
| 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? | High | ||
| DOMAIN 2: Index Test (FISH (variant 2)) | |||
| 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? | Unclear | ||
| 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? | No | ||
| Could the patient flow have introduced bias? | High risk | ||