NCT04520672

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
49mo left

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Oct 2020Aug 2030

First Submitted

Initial submission to the registry

August 5, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2030

Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

9.8 years

First QC Date

August 5, 2020

Last Update Submit

March 10, 2025

Conditions

Keywords

circulating tumor cells (CTCs)CTC clustersMolecular analysis of CTCsCTC cultureoverall survival (OS)progression free survival (PFS)

Outcome Measures

Primary Outcomes (2)

  • 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)

  • Change in total number of isolated CTCs

    Change in total number of isolated CTCs

    Through study completion, an average of 20 years

Secondary Outcomes (1)

  • Progression free survival (PFS)

    Through study completion, an average of 20 years

Other Outcomes (1)

  • Change in circulating tumor DNA (ctDNA) from blood samples

    Through study completion, an average of 20 years

Interventions

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.

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult patients (\> 18 years) with a cancer diagnosis

You may qualify if:

  • 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.

You may not qualify if:

  • No written informed consent.
  • No proved diagnosis of malignancy by pathology report.
  • Patients with the diagnosis of blood cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Department Oncology, Haematology & Immuntherapy, Kantonsspital Baselland

Liestal, 4410, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

CTC cultures stored in the refrigerator. A "Biobank Reglement" is enclosed to this protocol.

MeSH Terms

Conditions

NeoplasmsNeoplastic Cells, Circulating

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Marcus Vetter, PD Dr. med.

    Kantonsspital Baselland, Liestal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcus Vetter, PD Dr. med.

CONTACT

Nicola Aceto, Prof. Dr. med.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 20, 2020

Study Start

October 1, 2020

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2030

Last Updated

March 12, 2025

Record last verified: 2025-03

Locations