Clinical studies

AroCell TK 210 ELISA has been developed in response to unmet clinical needs.

AroCell is performing clinical investigations, both with partners and independently, to verify the safety, performance, and effectiveness of AroCell TK 210 ELISA with regards to a specific unmet clinical need. Arocell is currently involved in sex ongoing studies that will demonstrate the clinical benefit of AroCell TK 210 ELISA. Below can be found a description of ongoing and completed studies.

Ongoing studies

 

StudiePartnershipDescription
AROC 2016:2Södersjukhuset (Sös), StockholmIncludes up to 300 patients with suspected prostate cancer. The study aims to evaluate biomarkers for early detection of response to treatment. And to validate AroCell TK 210 ELISA in combination with PSA for monitoring of men with confirmed metastatic prostate cancer in late phase during hormone therapy.
AROC 2015:3Uppsala University Hospital, UppsalaAroCell TK 210 ELISA is used to investigate the TK1 levels in patients with Hodgkin's lymphoma. The TK1 concentration at diagnosis is compared with other methods of determining stages of lymphoma. The study includes serum samples from the UCAN biobank.
AROC 2015:4Uppsala University Hospital, UppsalaAroCell TK 210 ELISA is used to monitor the efficacy of rituximab (Rituxan®) + CHOP chemotherapy on patients suffering from DLBCL (Diffuse Large B-Cell Lymphoma), an aggressive form of non-Hodgkin's lymphoma. The study is retrospective and includes serum samples from 190 patients from the UCAN biobank. Serum samples are collected before treatment, during treatment and follow-up or relapse.
AROC 2016:4Helsinki Hospital, FinlandThis study includes 60 patients suffering from various forms of soft and hard tissue sarcoma. TK1 levels in serum samples from patients that are collected before, during and after treatment will be measured with AroCell TK 210 ELISA. To evaluate whether TK1 acts as a prognostic biomarker and to detect the relapse of the disease.
AROC 2019:1Dana-Farber Cancer Institute, USAThe purpose of the study is to evaluate AroCell TK 210 ELISA in patients treated with
CD-K4/6 inhibitors and to investigate compliance with TK1 content in serum and clinical response to treatment.
AROC 2020:1University Hospital of Pisa, ItalyIn the study TK1 protein levels will be assayed in serum samples collected from subjects with liver cancer, Hepatocarcinoma, prior to and during therapy and compared with the extent and speed of disease progression based on digital imaging. The combination of digital imaging with circulating biomarkers (Radiomics) can aid in identifying early therapeutic response, relapse and monitoring subsequent therapy. TK1 may be particularly important here as it may provide an indication of the rate of cellular proliferation in the tumour.

Completed studies

 

StudiePartnershipDescription
Breast cancerLjubljana University Medical Centre, SloveniaThe study included 124 breast cancer patients with known TNM classification as well as with known values from the established breast cancer marker CA 15-3, plus 53 healthy individuals. The study concluded that a study with a combination of TK 210 ELISA and CA 15-3 tests increases clinical sensitivity. The results suggest that TK 210 ELISA can provide independent and complementary information for patients with breast cancer.

Publication: https://link.springer.com/article
Prostate cancerLjubljana University Medical Centre, SloveniaThe study entitled "The combination of AroCell TK 210 ELISA with Prostate Health Index (PHI) or PSA density can improve the ability to differentiate prostate cancer from non-cancerous conditions". The aim was to investigate the diagnostic value of AroCell TK 210 ELISA together with free-PSA, Pro PSA and PHI to differentiate prostate cancer from benign urological diseases. Results suggest that TK1 concentration may be a valuable supplement to PHI or PSAD for diagnosing prostate cancer.

Publication: https://onlinelibrary.wiley.com
Breast cancerPROMIX project;
Department of Oncology-Pathology, at Karolinska
Institute and
University hospital at
Solna, Stockholm
Patients treated with Epirubicin and Docetaxel prior to surgery, had their Thymidine kinase 1 levels monitored in the blood to directly observe the response to treatment. The results showed that a TK1-based cell-loss value after two cycles of therapy was able to predict the status of surgery after six cycles of chemotherapy. The value could predict early on whether the chemotherapy is working or not.

Publication: Review ongoing: https://www.researchsquare.com/
Prostate cancerTammerfors
University hospital,
Finland
The purpose of the study was to determine the prognostic value of TK1, analyzed with AroCell TK 210 ELISA, in the diagnosis of patients with prostate cancer. In the study, the level of TK1 in serum samples was analyzed from patients with prostate cancer. The content of TK1 was be compared with the stage of cancer and the progression of the disease.

Publication: TBU

Investigator initiated clinical research studies

Today AroCell has several ongoing external collaborations. We are dedicated to supporting meaningful, independent clinical research conducted by qualified investigators. Studies are consistent with our areas of interest and our commitment to improving the care of patients suffering from cancer. AroCell may also provide funding and other forms of support, such as product and testing services.

All physicians, healthcare providers, researchers and institutions worldwide who are interested in conducting their research are eligible to submit a study proposal. All proposals are reviewed on their merit by a select review committee. Criteria for approval include scientific merit and alignment with the AroCell’s areas of interest.

For clinical research study proposal, please contact Michael Brobjer, Michael.Brobjer@arocell.com

Investigator and/or institution responsibilities include study design, execution and compliance with all institutional and regulatory requirements. Support is subject to resource availability and on the condition of an approved study concept proposal, full study protocol and full execution of a research support agreement by both parties.