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Recruiting NCT04520672

Circulating Tumor Cells (CTC) in Cancer

Observational Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood samples, Samples from tumor draining vessels.
Who it may be relevant to
Registry conditions: Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.
  • Other 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    In case of tumor resection, 3 EDTA tubes (5 ml) will be withdrawn from the tumor draining vessels for CTC isolation and characterization, ranging from molecular analysis to culture and drug screen.

Primary outcome measures

  • Overall survival (OS) in heterogeneous cancer population [Time frame: Screening (Visit 1) until the date of death (assessed up to 240 months)]
  • Change in total number of isolated CTCs [Time frame: Through study completion, an average of 20 years]
Secondary outcome measures (1)
  • Progression free survival (PFS) [Time frame: Through study completion, an average of 20 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 2 centers
  • University Hospital Basel — Basel
  • Department Oncology, Haematology & Immuntherapy, Kantonsspital Baselland — Liestal

Identifiers

NCT: NCT04520672 · 2020-00014; me19Vetter

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗