Thomas 2017.
Study characteristics | |||
Patient Sampling |
Inclusion/exclusion criteria Nested in a phase II study. Inclusion criteria: diagnosis of anaplastic oligodendroglioma or anaplastic oligoastrocytoma according to the WHO 2000 classification (mixed tumours should have a minimum of 25% oligodendroglial elements); aged ≥18 years; Karnofsky performance status ≥ 60; adequate organ and bone marrow function including a granulocyte count ≥ 1.5 × 109/L, platelet count of ≥ 100 × 109/L, aspartate aminotransferase ≤ 2× UNL, serum creatinine ≤1.5 × UNL and bilirubin ≤ 1.5 × UNL. Exclusion criteria: systemic or non‐contiguous leptomeningeal metastases; prior cranial RT or systemic chemotherapy; other concurrent malignancy with the exception of cervical carcinoma in situ or basal cell carcinoma of the skin; serious illness that would interfere with the prescribed treatment; pregnancy or lactation; refusal to use effective contraception. Prior testing Histopathological diagnosis according to the WHO 2000. Quote: "Within 2 weeks of starting treatment, all patients were evaluated with a complete history, physical and neurological examination, contrast enhanced MRI [magnetic resonance imaging], a biochemistry panel, and complete blood count and underwent screening for hepatitis B and C and HIV". |
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Patient characteristics and setting |
Number of participants/tumours with results for 1p/19q status by ≥ 2 DNA‐based tests: 19 Country: USA Population source and setting: phase II study Agea: median: 44 years, interquartile range: NR; range: 30–66 years Gender: 65.9% male Karnofsky performance status: median 90, range 70–100 First diagnosis/recurrent disease: unclear. Quote: "Patients with newly diagnosed AO [anaplastic oligodendroglioma] or AOA [anaplastic oligoastrocytoma] were eligible to participate in this prospective multicenter phase II study". aFor whole population: 41 people in the phase II study, only 19 had available tissue with adequate DNA quality and quantity for NGS. |
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Index tests |
2 tests: FISH and NGS FISH Tumour sample type: NR Region(s) analysed: NR Cut‐off: NR NGS Tumour sample type: NR Region(s) analysed: genome wide Cut‐off: NR Additional details: MSK‐IMPACT: a hybridisation capture‐based sequencing assay utilising an Illumina HiSeq 2500 platform. |
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Target condition and reference standard(s) | Target condition was absolute 1p/19q deletion. FISH 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? | 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) | |||
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? | No | ||
Could the conduct or interpretation of the index test have introduced bias? | High risk | ||
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | High | ||
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) | |||
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? | 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? | No | ||
Could the patient flow have introduced bias? | High risk |