The Correlation Between Circulatory Tumor Cells and Venous Thrombosis

September 19, 2025 updated by: Hsin-Fu Lee, Chang Gung Memorial Hospital

Research indicates a strong correlation between cancer and thrombosis, with approximately 20% of blood clots in the U.S. being cancer-related, according to CDC data. Cancer patients face a 4-7 times higher risk of thrombosis compared to non-cancer individuals. Certain cancer treatments, such as chemotherapy and targeted therapy, elevate the likelihood of venous thromboembolism (VTE). Cancer patients with VTE exhibit a significantly higher hazard ratio (H.R.) of 3.4 compared to those without VTE.

This study aims to explore three main topics: (1) Comparing the differences and similarities of leukocyte populations between cancer-associated thrombosis (CAT) and venous thromboembolism (VTE). (2) Characterizing the factors contributing to increased incidence of cancer-associated thrombosis (CAT), with the hypothesis that circulating tumor microemboli (CTM) may express more thrombosis-related proteins than CTCs. (3) Understanding the effects of aspirin or NOACs on cancer-associated thrombosis and CTM formation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Research indicates a strong correlation between cancer and thrombosis, with approximately 20% of blood clots in the U.S. being cancer-related, according to CDC data. Cancer patients face a 4-7 times higher risk of thrombosis compared to non-cancer individuals. Certain cancer treatments, such as chemotherapy and targeted therapy, elevate the likelihood of venous thromboembolism (VTE). Cancer patients with VTE exhibit a significantly higher hazard ratio (H.R.) of 3.4 compared to those without VTE.

The mechanisms underlying cancer-related thrombosis are intricate. Cancer cells can directly activate coagulation and platelets through various factors, including tissue factor (T.F.), particularly prevalent in specific cancers like pancreatic and ovarian, correlating with a heightened VTE risk and poorer prognosis. Additionally, factors such as podoplanin (PDPN), plasminogen activation inhibitor-1 (PAI-1), and cancer procoagulant (C.P.) further promote coagulation. Inflammatory cytokines originating from tumor cells and cancer-derived factors stimulate neutrophil extracellular traps, contributing to thrombosis.

Metastatic tumors facilitate cancer cell dissemination and entry into blood vessels, leading to thrombosis in certain instances. Analyzing circulating tumor cells (CTCs) from biopsies aids in comprehending cancer metastasis and identifying treatment targets. However, isolating these rare CTCs from blood presents a challenge. Endovascular therapy has made strides in thrombosis treatment, with endovascular thrombectomy showing promise in severe thrombosis cases. It is proposed that aspirating thrombi during this procedure could yield CTCs for further examination regarding the impact of cancer cells on thrombogenesis.

This study aims to explore three main topics: (1) Comparing the differences and similarities of leukocyte populations between cancer-associated thrombosis (CAT) and venous thromboembolism (VTE). (2) Characterizing the factors contributing to increased incidence of cancer-associated thrombosis (CAT), with the hypothesis that circulating tumor microemboli (CTM) may express more thrombosis-related proteins than CTCs. (3) Understanding the effects of aspirin or NOACs on cancer-associated thrombosis and CTM formation.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • New Taipei City, Taiwan
        • Recruiting
        • New Taipei City TuCheng Hospital
        • Contact:
          • Hsin-Fu Lee, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

patients who underwent catheter-based thrombectomy

Description

Inclusion Criteria:

  1. age≧18
  2. participants (1)participants without cancer: without cancer in five years (2)participants with cancer:pathology reveal have malignant tumor
  3. patients who underwent catheter-based thrombectomy
  4. agree do the thrombectomy

Exclusion Criteria:

  1. participants without cancer (1).shock (2).severe sepsis (3).with cancer in five years
  2. participants with cancer (1).shock (2).severe sepsis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cancer for CTC culture
a thrombosis patient with cancer .
Procedure: CTCs/CTMs culture
Collect the thrombosis from participants underwent catheter-based thrombectomy.To characterized by cancer-specific surface markers successfully and identify within the culture
health for CTC culture
a thrombosis patient without cancer
Procedure: CTCs/CTMs culture
Collect the thrombosis from participants underwent catheter-based thrombectomy.To characterized by cancer-specific surface markers successfully and identify within the culture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cell culture
Time Frame: baseline
cancer-specific surface markers
baseline
RNA-seq
Time Frame: baseline
DNA/RNA extraction of sorted cells as instruments' maneuvers and do the RNA-seq
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Director: Hsin-Fu Lee, PhD, New Taipei City TuCheng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2024

Primary Completion (Estimated)

May 27, 2026

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

October 31, 2024

First Submitted That Met QC Criteria

October 31, 2024

First Posted (Actual)

November 4, 2024

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202400562B0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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