Clinical trials in histopathology : Address the challenge of frozen tissue samples.

Clinical trials in histopathology : Address the challenge of frozen tissue samples.

Optimized management of frozen tissue samples ensures clinical trials reliability. When analysis methods are only applicable on tissue frozen samples, adapted procedures must be implemented.

On a standard basis pre analytical conditions to collect biopsies and tissue samples in the framework of a clinical trial require to fix the tissues for paraffin embedding. People familiar with histopatholgy acknowledge that it is critical to manage tissue removal conditions and tissue conservation in order to standardize the fixation conditions. The question is being raised when the central laboratory in histopathology must work on frozen tissue samples.

In certain circumstances biopsy fixations can prevent from getting analytical data which are indispensable to lead or interpret a clinical trial. For instance this is the case when pathological molecular testing are performed, though they are designed for DNA or RNA analysis without taking into account the bias induced by fixation. In other cases met by HISTALIM, primary antibodies have not been optimized yet to have enough robustness for immunohistochemistry staining on paraffin. Less frequently , but important to take into consideration, some analytical parameters cannot be obtained on a reliable standard thanks to FFPE: this is the case with greasy clusters.

Collect samples from clinical centers in appropriate conditions is a stake that must not be under-estimated. Upstream communication with clinical centers is crucial; it is necessary to send at each clinical center before the trial a clear and explicit sample manual, as well as a standardized kit. This solution enables to avoid issues with the sample identification by using a validated labelling system able to resist to temperature variations on which samples are exposed. The availability and the advices of a Principal Investigator part of the central laboratory are a good way to reassure clinicians and to guarantee the success of each phases until the delivery of the samples: taking over logistic issues, custom barriers, etc. Policies relative to tissue shipping, particularly with IATA standards, do not raise the same issues between fixed and frozen samples. Conditioning kits in addition with a trusted shipping partner are mandatory. According to the needs, embedded captors can demonstrate that the cold chain has been kept.

Frozen sample tissue management procedures must also to be handled on the central laboratory site. Specific rules must be taken for controlling the temperature of the samples from the reception to the whole course in the laboratory. To ensure the surveillance of temperature conditions, HISTALIM relies on the solutions provided by OCEASOFT. This company, recognized as the leader in wireless connected solutions for temperature & humidity monitoring, offers innovative monitoring solutions to protect sensible products during their storage and production. The tools combines Bluetooth® data loggers connected to mobile applications, PC and web. Thus it gives a simple access to the samples stored data: temperature are monitored 24h/7 and alerts and alarms are triggered as soon as an anomaly is detected.These solutions enable to demonstrate a posteriori the absence of deviation toward the rules defined in the study plan for the sample storage.

HISTALIM has also deployed additional measures to ensure the tissue storage in any circumstances. Secured access with alarm system and CCTV cameras have been installed to protect the freezers containing the tissue samples. Should a freezer fails, a backup freezer ensures continuity. And in case of electricity break down, a generator with 48h of autonomy will ensure the building power autonomy Eventually if none of these securities are not sufficient, HISTALIM has subscribed an insurance policy toward CELL & CO which guarantees a secured transfer of all the samples in less than 5 hours after the intervention request.

From surgical bloc removal to archiving , frozen tissue samples must be handled by an experienced central laboratory. The HISTALIM team can help you to achieve these goals, as well as design and validate robust analytical methods to weaken fixation effects.


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