Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells (HSP70CTC)

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

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 Overview

• Status: Recruiting
• Conditions: Sarcoma; Prostate Cancer; Pancreatic Cancer Stage IV; Breast Cancer Stage IV; Squamous Cell Carcinoma; Melanoma Stage IV
• Intervention / Treatment: Diagnostic test: CTC isolation by HSP70

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Sebastian Zschaeck, MD; Phone Number: +4930450650764; Email: sebastian.zschaeck@charite.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Klinik für Radioonkologie und Strahlentherapie
    • Contact: Sebastian Zschaeck, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

oncological patients treated at a tertiary center

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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
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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Klinikum rechts der Isar, TU München, (TUM), Munich, Germany.
• Investigators: Principal Investigator: Sebastian Zschaeck, MD, Charité

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2021
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Neoplastic Cells, Circulating
• Other Study ID Numbers: HSP70CTC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: patients can sign an optional agreement that their pseudonymized imaging and genetic data will be shared on cancerimagingarchive.net
• IPD Sharing Time Frame: data will be uploaded 2 years after study completion
• IPD Sharing Access Criteria: no specific criteria except proper referencing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No