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

Charite University, Berlin, Germany120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Melanoma Stage IV Sarcoma Squamous Cell Carcinoma Pancreatic Cancer Stage IV Prostate Cancer Breast Cancer Stage IV

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Radiographic response to initial treatment

radiographic response to treatment will be scored according to RECIST criteria and associated with the number of CTC

Time frame: 3 months after study enrollment

Secondary Outcomes

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

Time frame: 3 months (at both CTC assessment timepoints)

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

Time frame: 3 months (at both CTC assessment timepoints)

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

Time frame: 2 years

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