Circulating Tumor Cells (CTC) in Cancer

Cancer Clinical Trial

Official title:

Circulating Tumor Cells (CTC) in Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04520672
• Other study ID #: 2020-00014; me19Vetter
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: August 2030

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Marcus Vetter, PD Dr. med.
• Phone: +41 61 925 27 15
• Email: marcus.vetter[@]ksbl.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This observational study with circulating tumor cells (CTC) count, isolation and analysis at several time points during disease progression is to investigate the role and biology of CTCs and clusters of CTCs in different cancer types. It also evaluates the role of CTCs as biomarkers, and aims at the identification of key signaling networks that are active in CTCs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: August 2030
• Est. primary completion date: August 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult cancer patients

• All patients with histology-based proved diagnosis of cancer, all stages and subtypes can be included. Precancerous lesions cannot be included.

• All patients with the diagnosis of a solid tumor including adenocarcinoma, squamous cell carcinoma, neuroendocrine carcinoma, sarcoma

• Written pathology report must be available.

• Written informed consent.

Exclusion Criteria:

• No written informed consent.

• No proved diagnosis of malignancy by pathology report.

• Patients with the diagnosis of blood cancer

Related Conditions & MeSH terms

• Cancer
• Neoplastic Cells, Circulating

Intervention

Other:
• Blood samples
Blood samples (3 ethylenediaminetetraacetic acid (EDTA) tubes with a volume of 7.5 ml blood each) will be processed for CTC isolation and characterization, ranging from molecular analysis to culture and drug screen.
• Samples from tumor draining vessels
In case of tumor resection, 3 EDTA tubes (5 ml) will be withdrawn from the tumor draining vessels for CTC isolation and characterization, ranging from molecular analysis to culture and drug screen.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel
Switzerland	Department Oncology, Haematology & Immuntherapy, Kantonsspital Baselland	Liestal

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in circulating tumor DNA (ctDNA) from blood samples	Change in circulating tumor DNA (ctDNA) from blood samples	Through study completion, an average of 20 years
Primary	Overall survival (OS) in heterogeneous cancer population	overall survival (OS) in heterogeneous cancer population	Screening (Visit 1) until the date of death (assessed up to 240 months)
Primary	Change in total number of isolated CTCs	Change in total number of isolated CTCs	Through study completion, an average of 20 years
Secondary	Progression free survival (PFS)	progression free survival (PFS) in the different cancer cohorts with different treatment regimes	Through study completion, an average of 20 years