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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04628806
Recruitment Status : Not yet recruiting
First Posted : November 16, 2020
Last Update Posted : November 17, 2020
Sponsor:
Collaborator:
Klinikum rechts der Isar, TU München, (TUM), Munich, Germany.
Information provided by (Responsible Party):
Sebastian Zschaeck, 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.


Condition or disease Intervention/treatment
Melanoma Stage IV Sarcoma Squamous Cell Carcinoma Pancreatic Cancer Stage IV Prostate Cancer Breast Cancer Stage IV Diagnostic Test: CTC isolation by HSP70

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells in Patients With Advanced or Metastatic Tumors.
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Shock

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.




Primary Outcome Measures :
  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 Measures :
  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


Biospecimen Retention:   Samples With DNA
circulating tumor cells and biopsies


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
oncological patients treated at a tertiary center
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04628806


Contacts
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Contact: Sebastian Zschaeck, MD +4930450650764 sebastian.zschaeck@charite.de

Locations
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Germany
Klinik für Radioonkologie und Strahlentherapie
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Klinikum rechts der Isar, TU München, (TUM), Munich, Germany.
Investigators
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Principal Investigator: Sebastian Zschaeck, MD Charité
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Responsible Party: Sebastian Zschaeck, Doctor Sebastian Zschaeck, principal investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04628806    
Other Study ID Numbers: HSP70CTC
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: patients can sign an optional agreement that their pseudonymized imaging and genetic data will be shared on cancerimagingarchive.net
Time Frame: data will be uploaded 2 years after study completion
Access Criteria: no specific criteria except proper referencing.
URL: https://www.cancerimagingarchive.net/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplastic Cells, Circulating
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes