Bigner 1999.
Study characteristics | |||
Patient Sampling |
Inclusion/exclusion criteria Inclusion criteria: tumours composed partially or completely of neoplastic oligodendroglia (only cases on which there was agreement between 2 or 3 of the 3 observers for histological classification were included); frozen tissue and normal peripheral lymphocytes available. Prior testing Histopathological classification |
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Patient characteristics and setting |
Number of participants/tumours with results for 1p/19q status by ≥ 2 DNA‐based tests: 53 Country: USA Population source and setting: NR Age: mean: 39.9 years, standard deviation: 11.8 years Gender: 64.2% male Karnofsky performance status: NR First diagnosis/recurrent disease: unclear. We excluded the recurrences for people whose primary tumour was also included in the study. Some additional participants had had prior surgery or RT, unclear if the tumours studied were recurrences. |
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Index tests |
2 tests: CGH and PCR‐based LOH CGH Tumour sample type: frozen Region(s) analysed: genome wide Cut‐off: ratio of 0.85 indicated a loss. PCR Tumour sample type: frozen Region(s) analysed: FGR, MYCL1, AMY2B (1p); D19S217, D19S112, D19S412, STD, D19S596, D19S180, D19S254, D19S218 (19q) Cut‐off: a reduction in intensity > 50% in the tumour lane compared to the corresponding blood lane was scored as LOH. |
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Target condition and reference standard(s) | Target condition was absolute 1p/19q deletion. PCR‐based LOH used as reference standard in some of our analyses. | ||
Flow and timing | Both tests were performed on frozen tumour material. | ||
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) | |||
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? | 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 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 |