Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells

Prostate Cancer Clinical Trial

— HSP70CTC  

Official title:

Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells in Patients With Advanced or Metastatic Tumors.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04628806
• Other study ID #: HSP70CTC
• Status: Recruiting
• Start date: February 17, 2021
• Est. completion date: May 2022

Study information

• Verified date: May 2021
• Source: Charite University, Berlin, Germany
• Contact: Sebastian Zschaeck, MD
• Phone: +4930450650764
• Email: sebastian.zschaeck[@]charite.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Metastatic malignant melanoma (stage IV)

• Metastatic or unresectable pancreatic adenocarcinoma (stage III or IV)

• Metastatic breast cancer

• Metastatic sarcoma

• Metastatic squamous cell carcinoma of the cervix uteri, head and neck region, vulva, anus or penis

• hormone-refractory prostate cancer

Exclusion Criteria:

• psychiatric disorders that impede adequate informed consent

Related Conditions & MeSH terms

• Breast Cancer Stage IV
• Melanoma Stage IV
• Neoplastic Cells, Circulating
• Pancreatic Cancer Stage IV
• Prostate Cancer
• Sarcoma
• Squamous Cell Carcinoma

Intervention

Diagnostic Test:
• CTC isolation by HSP70
patients will receive additional blood examinations with quantification of circulating tumor cells by HSP70 antibodies and EpCAM.

Locations

Country	Name	City	State
Germany	Klinik für Radioonkologie und Strahlentherapie	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Klinikum rechts der Isar, TU München, (TUM), Munich, Germany.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic response to initial treatment	radiographic response to treatment will be scored according to RECIST criteria and associated with the number of CTC	3 months after study enrollment
Secondary	Correlation between number of CTC isolated with HSP70 compared to EpCAM	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	3 months (at both CTC assessment timepoints)
Secondary	Correlation between differential expressed radiommic parameters between primary tumor and metastases and genetic alterations of the primary tumor and CTCs	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	3 months (at both CTC assessment timepoints)
Secondary	Progression free survival	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	2 years
Secondary	Overall survival	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	2 years