Name of the Procedure:

Oncology (breast ductal carcinoma in situ), mRNA, gene expression profiling by real-time RT-PCR of 12 genes (7 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as recurrence score.

Summary

This procedure involves analyzing the gene expression of breast ductal carcinoma in situ (DCIS) tissue using a technique called real-time reverse transcription polymerase chain reaction (RT-PCR). By examining 12 specific genes, healthcare providers can assess the likelihood of cancer recurrence. The tissue sample used for this analysis is typically preserved in formalin and embedded in paraffin.

Purpose

The goal of this procedure is to determine the recurrence risk of breast ductal carcinoma in situ by profiling the expression of 12 genes. This aids in making informed decisions about the need for additional treatments such as radiation or hormone therapy.

Indications

This procedure is indicated for patients diagnosed with breast ductal carcinoma in situ (DCIS) to provide insights into the aggressiveness of the cancer and guide further treatment plans.

Preparation

• No special preparation is usually required from the patient.
• The tissue sample is obtained during a previous biopsy or surgery.
• Diagnostic tests like a biopsy are needed to obtain and prepare the tissue sample.

Procedure Description

1. A tissue sample from the DCIS lesion, previously collected and preserved in formalin and paraffin, is prepared for analysis.
2. RNA is extracted from the tissue sample.
3. Real-time reverse transcription polymerase chain reaction (RT-PCR) is performed to measure the expression of 12 genes (7 content genes and 5 housekeeping genes).
4. An algorithm calculates a recurrence score based on the gene expression levels.
5. The recurrence score is reported to guide future treatment decisions.

Duration

The procedure to extract RNA and perform RT-PCR typically takes a few hours, but the overall processing and analysis might take a few days.

Setting

This procedure is typically performed in a specialized laboratory equipped for molecular genetic analyses.

Personnel

• Pathologists
• Molecular biologists
• Laboratory technicians

Risks and Complications

• Minimal risk associated with the analysis itself, but accuracy depends on the quality of the tissue sample.
• Rare possibility of technical failure or error in processing, requiring a repeat analysis.

Benefits

• Provides a personalized recurrence score to guide treatment decisions.
• Helps avoid unnecessary treatments if the recurrence risk is low.

Recovery

• No physical recovery needed as the analysis is conducted on an existing tissue sample.
• No specific follow-up for the procedure itself, but results are discussed with the oncologist to plan further treatment.

Alternatives

• Conventional histopathological examination of the tissue.
• Other genomic tests or assays that might offer similar risk assessments.
• Each alternative has its own pros and cons in terms of accuracy, cost, and availability.

Patient Experience

• As the analysis is performed on an existing tissue sample, there is no direct patient involvement in the procedure.
• The patient may discuss the recurrence score with their healthcare provider to understand its implications for their treatment plan.