Tumor Cells, CirculatingNCT06672250
The Correlation Between Circulatory Tumor Cells and Venous Thrombosis
An observational study of Tumor Cells, Circulating and Venous Thrombosis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tumor Cells, Circulating, Venous Thrombosis
- What is being tested?
- CTCs/CTMs culture
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 May 2024to 30 Apr 2027
- How long will I take part?
- 1 Day
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients who underwent catheter-based thrombectomy
Who may be able to join
- age≧18
- participants (1)participants without cancer: without cancer in five years (2)participants with cancer:pathology reveal have malignant tumor
- patients who underwent catheter-based thrombectomy
- agree do the thrombectomy
Who cannot join
- participants without cancer (1).shock (2).severe sepsis (3).with cancer in five years
- participants with cancer (1).shock (2).severe sepsis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
New Taipei City TuCheng Hospital
New Taipei City
Hsin-Fu Lee, PhD
About this study
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.
Read the 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.
- Conditions
- Tumor Cells, Circulating, Venous Thrombosis
- Being tested
- CTCs/CTMs culture
- Keywords
- Cancer, Thrombosis, Venous thromboembolism, Circulating tumor cells, Endovascular therapy
- Medical subject headings
- Neoplastic Cells, Circulating, Venous Thrombosis, Neoplasms, Thrombosis, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTCs/CTMs cultureProcedure or surgery
Collect the thrombosis from participants underwent catheter-based thrombectomy.To characterized by cancer-specific surface markers successfully and identify within the culture
| Study group | Role | What they receive |
|---|---|---|
| cancer for CTC culture | a thrombosis patient with cancer . Receives: Procedure: CTCs/CTMs culture | |
| health for CTC culture | a thrombosis patient without cancer Receives: Procedure: CTCs/CTMs culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
cell culture
cancer-specific surface markers
Measured: baseline
RNA-seq
DNA/RNA extraction of sorted cells as instruments' maneuvers and do the RNA-seq
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start28 May 2024
- Primary completion27 May 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tumor Cells, CirculatingStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsin-Fu Lee, Chang Gung Memorial Hospital
- Investigators
- Hsin-Fu Lee, PhD, Study director, New Taipei City TuCheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672250
- Sponsor's protocol ID
- 202400562B0
- Status last verified
- Sep 2025
- First submitted
- 31 Oct 2024
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Falanga A, Russo L. Epidemiology, risk and outcomes of venous thromboembolism in cancer. Hamostaseologie. 2012;32(2):115-25. doi: 10.5482/ha-1170. Epub 2011 Oct 5.
PubMed 21971578
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Circulatory Tumor Cells and Venous Thrombosis
- ClinicalTrials.gov ID
- NCT06672250
- Acronym / sponsor ID
- 202400562B0
- Conditions
- Tumor Cells, Circulating, Venous Thrombosis
- Keywords
- Cancer, Thrombosis, Venous thromboembolism, Circulating tumor cells, Endovascular therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 28 May 2024 (actual)
- Primary completion
- 27 May 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 4 Nov 2024 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cancer for CTC culture | – | Procedure: CTCs/CTMs culturea thrombosis patient with cancer . |
| health for CTC culture | – | Procedure: CTCs/CTMs culturea thrombosis patient without cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent catheter-based thrombectomy
Key inclusion criteria (4 listed)
- age≧18
- participants (1)participants without cancer: without cancer in five years (2)participants with cancer:pathology reveal have malignant tumor
- patients who underwent catheter-based thrombectomy
- agree do the thrombectomy
Key exclusion criteria (2 listed)
- participants without cancer (1).shock (2).severe sepsis (3).with cancer in five years
- participants with cancer (1).shock (2).severe sepsis
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 |
|---|---|---|
| CTCs/CTMs cultureCollect the thrombosis from participants underwent catheter-based thrombectomy.To characterized by cancer-specific surface markers successfully and identify within the culture | Procedure or surgery | cancer for CTC culture, health for CTC culture |
Primary outcome
cell culture
Time frame: baseline
cancer-specific surface markers
RNA-seq
Time frame: baseline
DNA/RNA extraction of sorted cells as instruments' maneuvers and do the RNA-seq
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 24 Sep 2025.
- Results publication: PubMed 21971578Falanga A, Russo L. Epidemiology, risk and outcomes of venous thromboembolism in cancer. Hamostaseologie. 2012;32(2):115-25. doi: 10.5482/ha-1170. Epub 2011 Oct 5.
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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.
Hsin-Fu Lee, PhD study director
New Taipei City TuCheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor Cells, Circulating and Venous Thrombosis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 2 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 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 Hsin-Fu Lee, PhD (0975366105, 8805033@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cell culture (time frame: baseline). 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?
On the ClinicalTrials.gov record for NCT06672250, which also lists 1 linked publication.
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 24 Sep 2025.