HSP70CTC: Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells
Study Details
Study Description
Brief Summary
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 | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HSP70CTC 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.
|
Outcome Measures
Primary Outcome Measures
- Radiographic response to initial treatment [3 months after study enrollment]
radiographic response to treatment will be scored according to RECIST criteria and associated with the number of CTC
Secondary Outcome Measures
- Correlation between number of CTC isolated with HSP70 compared to EpCAM [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 [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 [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 [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Metastatic malignant melanoma (stage IV)
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Metastatic or unresectable pancreatic adenocarcinoma (stage III or IV)
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Metastatic breast cancer
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Metastatic sarcoma
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Metastatic squamous cell carcinoma of the cervix uteri, head and neck region, vulva, anus or penis
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hormone-refractory prostate cancer
Exclusion Criteria:
- psychiatric disorders that impede adequate informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinik für Radioonkologie und Strahlentherapie | Berlin | Germany | 13353 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
- Klinikum rechts der Isar, TU München, (TUM), Munich, Germany.
Investigators
- Principal Investigator: Sebastian Zschaeck, MD, Charité
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSP70CTC