Melanoma Stage IVHSP70CTCNCT04628806
Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells
An observational study of Melanoma Stage IV and Sarcoma, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Stage IV, Sarcoma, Squamous Cell Carcinoma
- What is being tested?
- CTC isolation by HSP70
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 17 Feb 2021to May 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: oncological patients treated at a tertiary center
Who may be able to join
- 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
Who cannot join
- psychiatric disorders that impede adequate informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Radioonkologie und Strahlentherapie
Berlin, 13353
Sebastian Zschaeck, M.D.
About this study
Official title: 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.
- Conditions
- Melanoma Stage IV, Sarcoma, Squamous Cell Carcinoma, Pancreatic Cancer Stage IV, Prostate Cancer, Breast Cancer Stage IV
- Being tested
- CTC isolation by HSP70
- Medical subject headings
- Melanoma, Sarcoma, Carcinoma, Squamous Cell, Pancreatic Neoplasms, Prostatic Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTC isolation by HSP70Diagnostic test
patients will receive additional blood examinations with quantification of circulating tumor cells by HSP70 antibodies and EpCAM.
| Study group | Role | What they receive |
|---|---|---|
| HSP70CTC | Isolation of circulating tumor cells by HSP70 Receives: Diagnostic Test: CTC isolation by HSP70 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic response to initial treatment
radiographic response to treatment will be scored according to RECIST criteria and associated with the number of CTC
Measured: 3 months after study enrollment
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start17 Feb 2021
- Primary completionFeb 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melanoma Stage IVStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum rechts der Isar, TU München, (TUM), Munich, Germany.
- Responsible party
- Principal investigator, Sebastian Zschaeck, Charite University, Berlin, Germany
- Investigators
- Sebastian Zschaeck, MD, Principal investigator, Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628806
- Sponsor's protocol ID
- HSP70CTC
- Acronym
- HSP70CTC
- Status last verified
- May 2021
- First submitted
- 9 Nov 2020
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: patients can sign an optional agreement that their pseudonymized imaging and genetic data will be shared on cancerimagingarchive.net
Publications
Roy AA, Pandey A, Dhas N, Hegde MM, Parekh HS, Andugulapati SB, Nandakumar K, Satish Rao BS, Mutalik S. The Confluence of Nanotechnology and Heat Shock Protein 70 in Pioneering Glioblastoma Multiforme Therapy: Forging Pathways Towards Precision Targeting and Transformation. Adv Pharmacol Pharm Sci. 2025 Apr 24;2025:1847197. doi: 10.1155/adpp/1847197. eCollection 2025.
PubMed 40313865
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells in Patients With Advanced or Metastatic Tumors.
- ClinicalTrials.gov ID
- NCT04628806
- Acronym / sponsor ID
- HSP70CTC / HSP70CTC
- Conditions
- Melanoma Stage IV, Sarcoma, Squamous Cell Carcinoma, Pancreatic Cancer Stage IV, Prostate Cancer, Breast Cancer Stage IV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Klinikum rechts der Isar, TU München, (TUM), Munich, Germany.
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSP70CTC | – | Diagnostic Test: CTC isolation by HSP70Isolation of circulating tumor cells by HSP70 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- oncological patients treated at a tertiary center
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- psychiatric disorders that impede adequate informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTC isolation by HSP70patients will receive additional blood examinations with quantification of circulating tumor cells by HSP70 antibodies and EpCAM. | Diagnostic test | HSP70CTC |
Primary outcome
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
4 secondary outcomes
Correlation between number of CTC isolated with HSP70 compared to EpCAM
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
Time frame: 3 months (at both CTC assessment timepoints)
Progression free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Derived from this study: PubMed 40313865Roy AA, Pandey A, Dhas N, Hegde MM, Parekh HS, Andugulapati SB, Nandakumar K, Satish Rao BS, Mutalik S. The Confluence of Nanotechnology and Heat Shock Protein 70 in Pioneering Glioblastoma Multiforme Therapy: Forging Pathways Towards Precision Targeting and Transformation. Adv Pharmacol Pharm Sci. 2025 Apr 24;2025:1847197. doi: 10.1155/adpp/1847197. eCollection 2025.
- Individual participant dataSharing planned: Yes. patients can sign an optional agreement that their pseudonymized imaging and genetic data will be shared on cancerimagingarchive.net
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Zschaeck, MD principal investigator
Charité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma Stage IV and Sarcoma, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Zschaeck, MD (+4930450650764, sebastian.zschaeck@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic response to initial treatment (time frame: 3 months after study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04628806, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021; AzTrials last refreshed its copy on 2 Nov 2026.