CancerNCT04520672
Circulating Tumor Cells (CTC) in Cancer
An observational study of Cancer, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Blood samples and Samples from tumor draining vessels
- How many people
- 3,000 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Oct 2020to Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: adult patients (> 18 years) with a cancer diagnosis
Who may be able to join
- 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.
Who cannot join
- No written informed consent.
- No proved diagnosis of malignancy by pathology report.
- Patients with the diagnosis of blood cancer
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Christian Kurzeder, PD Dr. med., +41 61 265 2525, christian.kurzeder@usb.ch
Christian Kurzeder, PD Dr. med.
- Recruiting
Department Oncology, Haematology & Immuntherapy, Kantonsspital Baselland
Liestal, 4410
Marcus Vetter, PD Dr. med., +41 61 925 27 15, marcus.vetter@ksbl.ch
Marcus Vetter, PD Dr. med.
About this study
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.
- Conditions
- Cancer
- Being tested
- Blood samples, Samples from tumor draining vessels
- Keywords
- circulating tumor cells (CTCs), CTC clusters, Molecular analysis of CTCs, CTC culture, overall survival (OS), progression free survival (PFS)
- Medical subject headings
- Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
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 vesselsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS) in heterogeneous cancer population
overall survival (OS) in heterogeneous cancer population
Measured: Screening (Visit 1) until the date of death (assessed up to 240 months)
Change in total number of isolated CTCs
Change in total number of isolated CTCs
Measured: Through study completion, an average of 20 years
Secondary outcomes (1)
Progression free survival (PFS)
progression free survival (PFS) in the different cancer cohorts with different treatment regimes
Measured: Through study completion, an average of 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start1 Oct 2020
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcus Vetter, PD Dr. med., Principal investigator, Kantonsspital Baselland, Liestal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520672
- Sponsor's protocol ID
- 2020-00014; me19Vetter
- Status last verified
- Mar 2025
- First submitted
- 5 Aug 2020
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor Cells (CTC) in Cancer
- ClinicalTrials.gov ID
- NCT04520672
- Acronym / sponsor ID
- 2020-00014; me19Vetter
- Conditions
- Cancer
- Keywords
- circulating tumor cells (CTCs), CTC clusters, Molecular analysis of CTCs, CTC culture, overall survival (OS), progression free survival (PFS)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 20 Aug 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients (> 18 years) with a cancer diagnosis
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- No written informed consent.
- No proved diagnosis of malignancy by pathology report.
- Patients with the diagnosis of blood cancer
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 |
|---|---|---|
| Blood samplesBlood 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 vesselsIn 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. | Other | – |
Primary outcome
Overall survival (OS) in heterogeneous cancer population
Time frame: Screening (Visit 1) until the date of death (assessed up to 240 months)
overall survival (OS) in heterogeneous cancer population
Change in total number of isolated CTCs
Time frame: Through study completion, an average of 20 years
Change in total number of isolated CTCs
1 secondary outcome
Progression free survival (PFS)
Time frame: Through study completion, an average of 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
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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.
Marcus Vetter, PD Dr. med. principal investigator
Kantonsspital Baselland, Liestal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcus Vetter, PD Dr. med. (+41 61 925 27 15, marcus.vetter@ksbl.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) in heterogeneous cancer population (time frame: Screening (Visit 1) until the date of death (assessed up to 240 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2025.