IFCC C-MD survey on Circulating Tumor (ct) DNA
Lab Demographics
1.
Which of the following best describes your laboratory demographics?
Private Laboratory
University affiliated laboratory
Medical Center affiliated laboratory
Large commercial laboratory (i.e., processes more than 1000 molecular tests per month)
Other– please specify
2.
In which country is your laboratory located?
3.
What is the typical number of patient samples that your laboratory services for all molecular diagnostics assays per week?
0-20
21-50
51-100
101-200
more than 200
4.
Is testing for patient care or research?
Patient Care
Clinical trials (therapeutic intervention)
Other clinical research
5.
For which cancer types does your laboratory conduct ctDNA analysis?
Lung cancer
Breast cancer and/or Ovarian cancer
CNS cancers
Colorectal cancer
Melanoma
Hematologic malignancies
Pancreatic cancer
Urothelial cancer
Prostate cancer
Renal cancer
Endocrine cancers
Other – please specify
6.
Which genes and mutations does your laboratory measure as ctDNA?
BRAF
EGFR
NRAS
KRAS
APC
AR
PIK3CA
We use panel diagnostics
Other – please list
7.
Which genes and mutations does your laboratory measure as ctDNA in panel diagnostics?
No, we don´t perform panel diagnostics.
Yes, please state the number of included genes and if commercial, panel name/version number
8.
How is ctDNA testing utilized at your institution?
Initial screening for mutations of interest
Tumor genomic profiling at diagnosis
Prognosis
Follow-up monitoring for minimal residual disease
Selection of targeted therapy (primary treatment)
Follow-up monitoring for resistance mutations
Serial monitoring for changes in abundance of target mutations (treatment response)
Selection of molecular targets at time of progression
9.
What criteria are used for selecting patients for ctDNA testing? (select all that apply)
No specific criteria
Advanced stage
Metastatic cancer
Failed/unable to conduct tumor testing
Companion diagnostics
Progression under targeted therapy
Research
Unknown
Other – specify
10.
Is ctDNA testing restricted to specific patients based on cancer stage or metastasis?
No.
Yes, we perform ctDNA testing for tumor stage IV
Yes, we perform ctDNA testing for tumor stage III
Yes, we perform ctDNA testing for tumor stage II
Yes, we perform ctDNA testing for tumor stage I
Yes, we perform ctDNA testing forScreening
11.
What frequency is ctDNA measured for your patients
Single time point
Serial testing - Monthly
Serial testing Following each treatment cycle
Serial testing Randomly
Other – please specify
12.
What type of blood collection tubes are you using?
Standard EDTA tubes
PAXgene tubes (Qiagen)
cfDNA tubes (Roche)
Streck BCT tubes
Other- please specify
13.
What criteria are used to reject a specimen that is collected for analysis?
14.
How do you store the specimen prior to analysis?
Room temperature
Refrigerated
Without temperature monitoring
Other- please specify
15.
What method is predominately used in your laboratory to analyse ctDNA?
Sequencing by use of unique molecular identifier (UMI). UMIs are a type of molecular barcoding that provides error correction and increased accuracy during sequencing.
Sequencing without UMI
Digital PCR
BEAMing
Quantitative PCR
Endpoint PCR
MassArray
Other – please specify
16.
Does your method of ctDNA analysis require extraction?
Yes.
No.
17.
What volume of specimen do you routinely extract?
1-3 ml
>3-5 ml
>5-10 ml
>10 ml
18.
Do you conduct pre-amplifications for any of your methods?
No.
Yes, please specify
19.
Do you monitor for genomic contamination?
No
Yes, what method do you use for this?
20.
What amount of isolated cfDNA is used for analysis?
Genome equivalents
Nanograms
please specify
21.
What specimen types does your laboratory use for ctDNA testing?
Plasma
CSF
Urine
Other please specify
22.
In what units are your ctDNA results reported?
Qualitative, positive/negative
Quantitative - Copies/mL
Quantitative - % mutant allel fraction
International Unit/ml
Other - please specify
23.
Are LOB (Limit of Blank), LOD (Limit of Detection) and LOQ (Limit of Quantification) determined for the methods used?
No
Yes, LOB
Yes, LOD
Yes, LOQ
Other please specify
24.
When the limit of blank (LOB) is determined, is this done specifically for the individual loci or is a general value used for all target genes ?
25.
Is the method-specific LOD (limit of detection) indicated when reporting the patient result?
Yes.
No.
26.
What is your typical turn-around time for ct-DNA analysis?
1–2 days
3-7 days
1–2 weeks
2–4 weeks
> 4 weeks
27.
Do you conduct quality control of the extraction procedure?
NO
Yes, please provide further information
28.
Certified reference materials (CRM) are defined as “sufficiently homogenous and stable with respect to one or more specified properties (qualitative or quantitative) which have been established to be fit for its intended use in a measurement process.” A CRM is distinguished and identified by a certificate that demonstrates not only the metrological traceability but also the uncertainty value of each property.
What methods do you apply for quality control of the extraction procedure?
Extraction of commercial "reference material"
Extraction of an in-house generated "reference material"
Extraction of certified reference materials (CRM)
Inclusion of a commercial internal standard
Inclusion of an in-house generated internal standard
Inclusion of certified reference materials (CRM)
Other – please specify
29.
What approaches do you apply for quality control of the analytical workflow? (select all that apply)
QC material
Internal standard
QC metrics (e.g. library yield, cluster density, read depth)
Other – please specify
30.
What source do you use for quality control?
Seracare (LGC Clinical Diagnostics)
Horizon
Thermo Fisher Scientific (Acrometrix)
In house developed
Other please specify
31.
Do you perform external quality assessments of your ctDNA methods?
NO
Yes, please name the name of the EQA provider
32.
What resources are needed to advance the quality and standardization of ctDNA testing
Additional external quality assurance programs
Expansion of the scope of existing external quality assurance programs
Commercially available quality control material
Pre-analytical/ extraction controls
Certified reference materials
Reference methods to support traceability
Practice guidelines
Other – please specify
33.
Comments, opinions, recommendations, questions – please specify
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