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

NCT04628806 | Unknown

• 1 other identifier: HSP70CTC
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma Stage IV; Sarcoma; Squamous Cell Carcinoma; Pancreatic Cancer Stage IV; Prostate Cancer; Breast Cancer Stage IV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Correlation between number of CTC isolated with HSP70 compared to EpCAM

  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

  3 months (at both CTC assessment timepoints)

• Progression free survival

  2 years

• Overall survival

  2 years

Study Arms (1)

HSP70CTC

Isolation of circulating tumor cells by HSP70

Diagnostic Test: CTC isolation by HSP70

Interventions

CTC isolation by HSP70 DIAGNOSTIC_TEST

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

HSP70CTC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

oncological patients treated at a tertiary center

You may qualify if:

• 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

You may not qualify if:

• psychiatric disorders that impede adequate informed consent

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Klinikum rechts der Isar, TU München, (TUM), Munich, Germany.: collaborator

Study Sites (1)

Klinik für Radioonkologie und Strahlentherapie

Berlin, 13353, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 40313865 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

circulating tumor cells and biopsies

MeSH Terms

Conditions

Melanoma; Sarcoma; Carcinoma, Squamous Cell; Pancreatic Neoplasms; Prostatic Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Connective and Soft Tissue; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases

Study Officials

• Sebastian Zschaeck, MD

  Charité

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Zschaeck, MD

CONTACT

+4930450650764; sebastian.zschaeck@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Sebastian Zschaeck, principal investigator

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 16, 2020
• Study Start: February 17, 2021
• Primary Completion: February 1, 2022
• Study Completion: May 1, 2022
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: data will be uploaded 2 years after study completion
• Access Criteria: no specific criteria except proper referencing.

Locations

DE (1)