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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04628806

Studienbeginn:
Februar 2021

Letztes Update:
14.05.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplastic Cells, Circulating

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Charite University, Berlin, Germany

Collaborator:
Klinikum rechts der Isar, TU München, (TUM), Munich, Germany.

Studienleiter

Sebastian Zschaeck, MD
Principal Investigator
Charité

Kontakt

Sebastian Zschaeck, MD
Kontakt:
Phone: +4930450650764
E-Mail: sebastian.zschaeck@charite.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Klinik für Radioonkologie und Strahlentherapie
13353 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Sebastian Zschaeck, M.D.» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Radiographic response to initial treatment (Time Frame - 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:

1. Correlation between number of CTC isolated with HSP70 compared to EpCAM (Time Frame - 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

2. Correlation between differential expressed radiommic parameters between primary tumor and metastases and genetic alterations of the primary tumor and CTCs (Time Frame - 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

3. Progression free survival (Time Frame - 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

4. Overall survival (Time Frame - 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

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

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