Clinical Trials

12,765 clinical trial subjects worldwide have been tested with CST’s blood test

CST’s cancer detection technology in its existing blood test form has been proven to detect 14 major cancers in published clinical trials.

Trials have been conducted in America, Australia, Canada, China, Chile, Germany, Hong Kong, India, Korea,
Malaysia, Singapore, Taiwan, Turkey, and Vietnam that clinically proved the efficacy of the CST test to detect multiple cancers.

In Q3 2015 CST will begin further larger clinical trials in China, Singapore, and Malaysia focused on Lung, Liver, & NPC Cancers using the rapid cancer test.

Published Clinical Trials
Wuhan China 1998:
“Clinical Performance of the DR-70 immunoassay kit for cancer detection.” Wu, D., Zhou, X., Yang, G., Xie, Y., Hu, M., Wu, X., Yang, G., and Lu, M. J Immunoassay 19, 63-72 (1998)

Dept. Clinical Laboratory, Hubei Medical University, Wuhan, China

413 subjects (277 healthy controls, 136 cancer patients)
Results: Specificity 95%.
Lung: Sensitivity 87.8%
Colon: Sensitivity 66.7%.
Breast: Sensitivity 65.2%
Stomach: Sensitivity 92.6%

Multicenter Study USA and China 1999:
“Sensitivity and Specificity of DR-70 Lung Cancer Immunoassay.” Wu, D., Zhou, X., Anderson, G., Fuentes, A., Slater, L.M., Narinesingh, D., Jimenez, P., and Gopoesingh, T. Analytical Letters 32, 1351-1362 (1999) Dept. of Medicine, University of California, CA, USA, Dept. Chemistry, The University of the West Indies, Augustine, Trinidad, Dept. Clinical Laboratory, Hubei Medical University, Wuhan, China, Dept. Obstetrics and Gynecology, Eric Williams Medical Sciences Complex, Trinidad

A multicenter study in the USA and China to investigate the utility of DR-70. Interference to DR-70 due to different disease states and blood collection procedures were also investigated. Benign and non-cancer diseases included pneumonia, lung infection, acute and chronic infections, burns, trauma, surgery, rheumatoid arthritis, renal failure, sepsis, jaundice, cellulitis, etc were also studied. (Benign non-cancer samples were obtained from the Department of Pathology, University of California.)

596 Subjects (393 healthy controls – age range 18 to 70, 203 lung cancer patients – age range 29 to 80)
USA; Sensitivity 86%. Specificity 96%.
China; Sensitivity 87%. Specificity 95%.

Chongqing China 1999:
“Application of tumour marker of DR-70 in the diagnosis of malignant tumours.” Ding, L., Ping, S. and Jingmei, Y. Chongquing Med J 28, 1-3 (1999) Central Research Laboratory, Cancer Research Centre, Chongqing Cancer Institute, Chongqing, Sichuan, China.

79 subjects (59 Cancer patients – 20 Liver cancer, 18 lung cancer, 7 ovarian cancer, 6 breast cancer, 5 stomach cancer, 2 lymphoma, 1 brain cancer; 20 healthy controls) Age range 20 to 45.

General result: Specificity 95%.
Liver: Sensitivity 95%.
Lung: Sensitivity 83.3%
Ovarian: Sensitivity 85.7%.
Breast: Sensitivity 66.7%
Stomach: Sensitivity 80%.
Mal. Lymph.: Sensitivity 100%
Brain: Sensitivity 100%

Frankfurt Germany 2004:
“The new DR-70 immunoassay detects cancer of the gastrointestinal tract: a validation study.” Kerber, A., Trojan, J., Herrlinger, K., Zgouras, D., Caspary, W.F., and Braden, B. Aliment Pharmacol Ther 20, 983-987 (2004) Universities of Frankfurt and Main, Germany.

185 Subjects (100 healthy controls – age range 18 to 66; 85 cancer patients – age range 37 to 89 – Cancers: 19 hepatocellular, 10 cholangiocellular, 30 colorectal, 13 pancreatic, 10 stomach, 3 esophagus.)
Sensitivity 91%. Specificity 93%.
Positive predictive value average: 91.7%
Negative predictive value average: 92.08%
Efficacy average: 91.9%
Heptocellular: Sensitivity 94.7%.
Cholangiocellular: Sensitivity 100%
Colorectal: Sensitivity 80%.
Pancreatic: Sensitivity 92.3%
Stomach: Sensitivity 90%.
Oesophageal.: Sensitivity 100%
CEA was also used in the trial as a comparitive test for Colorectal cancer: Sensitivity 43.3%.
Patients with advanced tumour spread showed significantly higher values of DR-70 than those with early stage tumours. DR-70 levels positively correlated with tumour load and number of metastatic sites. Early-stage cancer patients obtained a very satisfying result; Sensitivity 89.2% and Specificity 93%. DR-70 cannot be considered an organ- specific tumour marker. It detects multiple cancers with a high degree of Sensitivity and Specificity. DR-70 could be used as a global serological cancer detection tool, not limited to specific tumour types.

Wuhan University China 2005:
“Serum concentration of DR-70 for the diagnosis and prognosis of carcinoma of the tongue.” Li, X., Qiao, Z., Long, X., Wei, J. & Cheng, Y. Br J Oral Maxillofac Surg 43, 513-515 (2005), Dept of Oral Surgery, College of Stomatology, Wuhan University. Dept of Microbiology College of Medicine, Wuhan University China

134 subjects (52 Cancer patients, 40 healthy controls, 42 with benign lesions – age range 13 to 78)
Sensitivity 73%. Specificity 92.5%.
There were no significant difference in DR-70 results for the healthy controls and those with benign lesions.
Importantly, this study also followed the survival of patients after the trial for 3 years to monitor the DR-70 results (levels) relative to the stages of cancer – T1 to T4. DR-70 predicted an 87% successful survival of those patients whose DR-70 levels indicated a T1 to T2 stage of cancer, and 71% success at predicting death of those patients whose DR-70 levels indicated a T3 to T4 stage cancer.

Samsung Hospital Korea 2006:
“Meaning of the DR-70 Immunoassay for Patients with the Malignant Tumour.” Lee, K-H., Cho, D., Kim, K-M., Kim, S-M. & Lee, D-J. Immune Network 6, 43-51 (2006), Samsung Medical Centre, Cancer Centre, Seoul, Korea, Samsung Life Sciences Research Centre, Seoul Korea.

4,169 subjects (42 Cancer patients, breast, ovarian, thyroid, gastric, hepatic,
colon, rectal; 4,127 healthy controls)
Sensitivity 71.4%. Specificity 70.1%
Trial was conducted as a blind trial with subjects who visited the Cancer Centre over a period of 13 months. The patient group were subjects who were newly diagnosed with cancer (no reference to stage). There was statistical significance established when categorized by the type of malignant tumor. All cancer patients with the exception of the subgroups of colon and rectal showed significantly higher mean DR-70 levels compared to the control group. A significant increase in the mean DR-70 value was observed in the cancer group (thyroidal, gastric, breast, hepatic and ovarian) compared with the control group. In particular, the specificity and sensitivity of the DR-70 immunoassay was relatively high in the subgroups of breast, gastric, and thyroidal cancer patients. There is need for further studies on a large number of malignant tumor patients to see how the DR-70 level might be changed according to the differentiation grade and postoperative prognosis of the malignant tumor.

University of Mainz Germany Two clinical trials 2006/2007:
“Ovarian Carcinoma: Clinical Validity by Simultaneous Determination of Fibrin Degredation Products with the DR 70 Immunoassay and CA-125.”, Schaffrath, M., Harter, P., Wulgaris, S., Seufert, R., du Bois, A. and Pollow, K. German J Obstetrics and Gynocology 66, 68-75 (2007)

1st Trial:
148 subjects (48 Ovarian Cancer patients, 100 healthy controls)
Sensitivity 70.9%. Specificity 89.7%.
2nd Trial 2007:
161 subjects (61 Ovarian Cancer patients, 100 healthy controls)
Sensitivity 83.6%. Specificity 100%.

Un-Published Blood Test Clinical Trials
Nil Ratan Sarkar Medical College, Kolkata, West Bengal, India “The Importance of DR-70 in the Diagnosis of Malignant Tumours – a Study of Women.” Amitabha Sengupta, Arnab Maji, Debraj Jash, Malay Maikap Department of Gynecology and Obstetrics, Nilratan Sircar Medical College and Hospital, Kolkata, West Bengal, India.