Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells (HSP70CTC)
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|ClinicalTrials.gov Identifier: NCT04628806|
Recruitment Status : Not yet recruiting
First Posted : November 16, 2020
Last Update Posted : November 17, 2020
This study investigates the ability of heat shock protein HSP70 to isolate and quantify circulating tumor cells (CTCs) in patients with advanced or metastatic tumors.
CTCs will be isolated from peripheral blood before antineoplastic treatment and again after three months. Isolation using HSP70 will be compared with standard CTC isolation by EpCAM.
Additionally, imaging parameters of the primary tumor (if available) and metastases will be analysed and correlations between molecular alterations and imaging parameters will be assesed.
|Condition or disease||Intervention/treatment|
|Melanoma Stage IV Sarcoma Squamous Cell Carcinoma Pancreatic Cancer Stage IV Prostate Cancer Breast Cancer Stage IV||Diagnostic Test: CTC isolation by HSP70|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||120 participants|
|Target Follow-Up Duration:||3 Months|
|Official Title:||Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells in Patients With Advanced or Metastatic Tumors.|
|Estimated Study Start Date :||February 2021|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||May 2022|
Isolation of circulating tumor cells by HSP70
Diagnostic Test: CTC isolation by HSP70
patients will receive additional blood examinations with quantification of circulating tumor cells by HSP70 antibodies and EpCAM.
- Radiographic response to initial treatment [ Time Frame: 3 months after study enrollment ]radiographic response to treatment will be scored according to RECIST criteria and associated with the number of CTC
- Correlation between number of CTC isolated with HSP70 compared to EpCAM [ Time Frame: 3 months (at both CTC assessment timepoints) ]the number of CTCs obtained by the novel HSP70 method will be compared to the current gold standard that uses EpCAM. This will be performed for the whole cohort and separate for each tumor site
- Correlation between differential expressed radiommic parameters between primary tumor and metastases and genetic alterations of the primary tumor and CTCs [ Time Frame: 3 months (at both CTC assessment timepoints) ]computed tomography parameters of primary tumors and metastases will be analysed and parameters extraced that are differentially expressed between both. The same will be performed for genomic mutations and gene expression of the primary tumor and CTC. Correlation analyses will be performed to analyze if radiographic parameters resemble genetic alterations
- Progression free survival [ Time Frame: 2 years ]Progression free survival will be evaluated with the number of CTC as variable. This will be performed for the whole cohort and separate for each tumor site
- Overall survival [ Time Frame: 2 years ]Overall survival will be evaluated with the number of CTC as variable. This will be performed for the whole cohort and separate for each tumor site
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04628806
|Contact: Sebastian Zschaeck, MDemail@example.com|
|Klinik für Radioonkologie und Strahlentherapie|
|Berlin, Germany, 13353|
|Principal Investigator:||Sebastian Zschaeck, MD||Charité|