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2021-02-17
2022-02
2022-05
120
NCT04628806
Charite University, Berlin, Germany
Charite University, Berlin, Germany
OBSERVATIONAL
Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-11-09 | N/A | 2021-05-12 |
2020-11-09 | N/A | 2021-05-14 |
2020-11-16 | N/A | 2021-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : HSP70CTC Isolation of circulating tumor cells by HSP70 | DIAGNOSTIC_TEST: CTC isolation by HSP70
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Sebastian Zschaeck, MD Phone Number: +4930450650764 Email: sebastian.zschaeck@charite.de |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
