StageCheck

Improved accuracy of staging using the Previstage™ GCC Colorectal Cancer Staging Test

The presence of tumour cells in regional lymph nodes is the strongest independent predictor of recurrence in patients with colorectal cancer but without distal metastasis¹, being associated with a poorer prognosis and an increased risk of recurrent disease. However, current histological methods to detect lymph node metastasis have limited sensitivity, and up to 30% of patients with Stage I-II (pN0) colorectal cancer (CRC) return with recurrent disease.

A recent prospective multicenter clinical study, published in JAMA in 2009¹, showed how the detection of Guanylyl Cyclase C (GCC) mRNA in lymph nodes from CRC patients can be used to assess the risk of rectal or colon cancer recurrence. Patients with GCC positive lymph nodes were 4.7 times more likely to develop disease recurrence than GCC negative patients.

Previstage™ GCC Colorectal Cancer Staging Test is a clinically validated test for the detection of GCC mRNA in lymph nodes from CRC patients. This test is a new diagnostic tool that can improve the accuracy of staging, prognosis of clinical outcomes - representing a key advance in the management of patients with colorectal cancer.

The Previstage™ GCC Colorectal Cancer Staging Test, developed by DiagnoCure Oncology Laboratories, US, is available exclusively from Lab21 in the UK and Ireland as StageCheck.

The link between GCC and Colorectal Cancer Staging
Development of the Previstage™ GCC Test
Comparison of histology and Previstage™ GCC Test
More information on the Previstage™ GCC Test
How to use StageCheck
Published References on Previstage™ GCC Colorectal Cancer Staging Test

The link between GCC and Colorectal Cancer Staging

back to top

The link between GCC (GUCY2C, guanylyl cyclase C) mRNA and colorectal cancer was discovered in the early 1990’s by Dr. Scott Waldman at Thomas Jefferson University, US. In 2009, Dr. Waldman and his group published the results of a 5-year prospective multicenter clinical study on the detection of GCC mRNA in lymph nodes to assess the risk of rectal or colon cancer recurrence in patients¹. The study results strongly support the prognostic value of GCC testing and show that patients with GCC positive lymph nodes are 4.7 times more likely to develop disease recurrence than GCC negative patients.

Indeed, in an educational session held during the 2009 Gastrointestinal Cancers Symposium (ASCO GI) which reviewed different markers for colorectal cancer prognosis, it was suggested that patients with GCC positive lymph nodes could be considered as Stage III patients.

Click here for the presentation

Development of the Previstage™ GCC Test

back to top

The GCC qRT-PCR assay used in the Waldman 2009 study¹ was performed on mRNA extracted from frozen tissue samples. As collection and storage of frozen lymph nodes is not part of standard clinical practice, the qRT-PCR assay was adapted for formalin-fixed, paraffin embedded (FFPE) tissue to develop the clinically validated Previstage™ GCC Colorectal Cancer Staging Test.

Comparison of histology and Previstage™ GCC Test

back to top

Histological examination of lymph nodes:

• Maximum sensitivity: 1 cancer cell in 200 normal cells
• Volume of lymph node typically examined: <1%

Previstage™ GCC Colorectal Cancer Staging Test:

• qRT-PCR maximum sensitivity: 1 cancer cell in 10 million normal cells
• Volume of lymph node typically examined: 50%
• Analytical sensitivity 92%, specificity 98%²

Using the current histopathological methods alone, up to 30% of patients diagnosed with Stage I or II (pN0) cancer return with recurrent disease. This may be due to undetected metastasis. Use of the Previstage™ GCC test can help identification of patients most at risk of cancer recurrence.

More information on the Previstage™ GCC Test

back to top

More information on the Previstage™ GCC Colorectal Cancer Staging Test can be found on the DiagnoCure Oncology Laboratories website. On this site, you can also find many references for scientific literature on GCC and colorectal cancer.

How to use StageCheck

back to top

StageCheck is a service for the Previstage™ GCC Colorectal Cancer Staging Test, provided exclusively by Lab21 in the UK and Ireland.

StageCheck by Lab21

To use StageCheck, the first point of contact is Lab21 Customer Services, who handle:

• Test Requests and Customer Support
• Liaison with Sample Retention Sites for sample retrieval
• Organisation of Sample logistics for testing at DiagnoCure Oncology Laboratories
• Reporting of the Results - typically within 15 working days from receipt of sample at Lab21

Lab21 Customer Services can be contacted by phone:
0845 6778108 (UK)
+44 (0)1223 395450 (International)

Or by email:
stagecheck@lab21.com

StageCheck requires whole or bisected formalin-fixed paraffin embedded (FFPE) lymph nodes from the colorectal cancer patient. One half of each lymph node is used for testing (lymph nodes measuring 2mm or less are used in their entirety), and the remaining tissue is returned to the Sample Retention Site. The more lymph nodes are tested, the more informative the test result is.

You can click on the links below to view:

Test Request Form
Sample Preparation
Example Test Report

The Previstage™ GCC Colorectal Cancer Staging Tests are performed exclusively by DiagnoCure Oncology Laboratories, a CLIA-certified service laboratory located in West Chester, Pennsylvania.

Previstage™ is a trademark of DiagnoCure Inc.

Published References on the Previstage™ GCC Colorectal Cancer Staging Test

back to top

1. Waldman et al. Association of GUCY2C expression in lymph nodes with time to recurrence and disease-free survival in pN0 colorectal cancer. JAMA, 2009; 301(7): 745-752.
2. Carlson MR. Previstage™ GCC Colorectal Cancer Staging Test. Mol Diag Ther 2009; 13(1): 11-14.