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

• Conditions: Pancreatic Cancer Stage IV; Sarcoma; Squamous Cell Carcinoma; Prostate Cancer; Breast Cancer Stage IV; Melanoma Stage IV
• Interventions: Diagnostic Test: CTC isolation by HSP70

• Registration Number: NCT04628806
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-16
• Study Start: 2021-02-17
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-12
• Last Update Posted: 2021-05-14
• Primary Completion: 2022-02
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HSP70CTC	CTC isolation by HSP70	Isolation of circulating tumor cells by HSP70

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Klinik für Radioonkologie und Strahlentherapie; 🇩🇪 Berlin, Germany