Neoplasm MetastasisGCTHCMNCT05939960
Application of a New Type of Whole Blood Coagulation Time Measurement in Evaluating the Hypercoagulable State of Malignant Tumors
An observational study of Neoplasm Metastasis and Blood Coagulation Disorder With Shortened Coagulation Time (Disorder), run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
Malignant tumors are closely related to deep vein thrombosis, Pulmonary embolism and other diseases. Tumor patients usually have a hypercoagulable state (HCS) in their blood, and the proportion of thrombosis caused by HCS is more than 10 times that of non tumor patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastasis, Blood Coagulation Disorder With Shortened Coagulation Time (Disorder), Venous Thromboembolism
- What is being tested?
- CGT test
- How many people
- 354 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 30 Sep 2024
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
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: According to the commonly used Caprini Thrombosis Risk Score and Khrona Thrombosis Risk Score in clinical practice, patients with Caprini score ≥ 5 and Khrona score ≥ 2 have a VTE incidence rate of 8.8% -14.6%; The expected incidence of VTE in patients with shortened whole blood GCT time is 30%; Based on sample size calculation, Class I error α= 0.025, Class II error β= 0.05, bilateral test, loss of follow-up rate of 10%, calculated sample size of 76 cases. It is predicted that patients with shortened GCT time account for 30% of all tumor patients, and 254 patients need to complete GCT testing. Therefore, the overall sample size required for this study is 254 cases.
Who may be able to join
- Voluntarily participate and sign an informed consent form;
- Age ≥ 18 years old
- Expected survival time>6 months;
- Patients diagnosed with malignant tumors for the first time or progressing during treatment;
- Solid malignant tumors with clear pathological diagnosis;
- ECOG physical fitness score ≤ 2 points
Who cannot join
- Patients with known venous thrombosis (including upper and lower limb venous thrombosis, Pulmonary embolism, visceral venous thrombosis, etc.);
- Patients who have received long-term treatment with Warfarin, Rivaroxaban, and low-molecular-weight heparin (except aspirin, hydrogen Clopidogrel, etc.);
- Patients with active infections and sepsis;
- Hematology tumor (except lymphoma);
- Patients who undergo any major surgical treatment within 28 days prior to enrollment;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300170
Qiong Qin, Doctor, 862260814993, qinqiong315@tmu.edu.cn
About this study
Malignant tumors are closely related to deep vein thrombosis, Pulmonary embolism and other diseases. Tumor patients usually have a hypercoagulable state (HCS) in their blood, and the proportion of thrombosis caused by HCS is more than 10 times that of non tumor patients. Conventional clinical testing methods such as coagulation function, blood routine, and thromboelastography are difficult to directly evaluate the hypercoagulable state of tumor patients. In addition, the widely used Khorana score and Caprini score systems in clinical practice need to be improved in accurately reflecting the hypercoagulable state of tumor patients.
Our team has established a complete new coagulation time measurement system, including general clotting time (GCT), platelet rich plasma clotting time (PRP-CT), and platelet poor plasma clotting time (PPP-CT), which may be a new and accurate method for evaluating tumor hypercoagulability.
Read more
The GCT study aims to evaluate: 1. The time of GCT, PRP-CT, and PPP-CT for malignant tumors is shorter than that of normal individuals, and some patients are in a hypercoagulable state; 2. The shortened time of GCT, PRP-CT, and PPP-CT may be associated with future thrombosis; 3. Evaluating the relationship between shortened GCT system time and overall tumor survival
Therefore, the GCT system evaluation may identify patients who are truly in a hypercoagulable state, providing monitoring indicators for subsequent anticoagulation; It can also be evaluated whether GCT time can reflect the prognosis of tumor patients.
- Conditions
- Neoplasm Metastasis, Blood Coagulation Disorder With Shortened Coagulation Time (Disorder), Venous Thromboembolism
- Being tested
- CGT test
- Keywords
- Neoplasm Metastasis, Blood Coagulation Disorder, Venous Thromboembolism
- Medical subject headings
- Neoplasm Metastasis, Venous Thromboembolism, Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGT testDiagnostic test
GCT、PRP-CT、PPP-CT monitor
| Study group | Role | What they receive |
|---|---|---|
| Normal group | GCT time within normal range；Normal coagulation function Receives: Diagnostic Test: CGT test | |
| hypercoagulable group | GCT time reduction； Normal coagulation function, Receives: Diagnostic Test: CGT test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compared with non tumor patients, the GCT time of tumor patients is significantly GCT shortened in neoplames
Compared with non tumor patients, the GCT time of tumor patients is significantly shortened
Measured: July 1,2023 to September 30,2024
Secondary outcomes (1)
theincreased incidence of VTE
In patients with shortened GCT, the incidence of VTE increases.
Measured: July 1,2023 to September 30,2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Jul 2023
- Primary completion28 Feb 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MetastasisStudies 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
- 354 participants (estimated)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiong Qin, Tianjin Medical University General Hospital
- Investigators
- Zhang Jianning, Doctor, Principal investigator, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939960
- Sponsor's protocol ID
- IRB2023-RTFL-134
- Acronym
- GCTHCM
- Status last verified
- Jul 2023
- First submitted
- 1 Jul 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After completing the research thoroughly, apply for and obtain the consent of PI to access the data
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a New Type of Whole Blood Coagulation Time Measurement in Evaluating the Hypercoagulable State of Malignant Tumors
- ClinicalTrials.gov ID
- NCT05939960
- Acronym / sponsor ID
- GCTHCM / IRB2023-RTFL-134
- Conditions
- Neoplasm Metastasis, Blood Coagulation Disorder With Shortened Coagulation Time (Disorder), Venous Thromboembolism
- Keywords
- Neoplasm Metastasis, Blood Coagulation Disorder, Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 11 Jul 2023 (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.
Malignant tumors are closely related to deep vein thrombosis, Pulmonary embolism and other diseases. Tumor patients usually have a hypercoagulable state (HCS) in their blood, and the proportion of thrombosis caused by HCS is more than 10 times that of non tumor patients. Conventional clinical testing methods such as coagulation function, blood routine, and thromboelastography are difficult to directly evaluate the hypercoagulable state of tumor patients. In addition, the widely used Khorana score and Caprini score systems in clinical practice need to be improved in accurately reflecting the hypercoagulable state of tumor patients.
Our team has established a complete new coagulation time measurement system, including general clotting time (GCT), platelet rich plasma clotting time (PRP-CT), and platelet poor plasma clotting time (PPP-CT), which may be a new and accurate method for evaluating tumor hypercoagulability.
The GCT study aims to evaluate: 1. The time of GCT, PRP-CT, and PPP-CT for malignant tumors is shorter than that of normal individuals, and some patients are in a hypercoagulable state; 2. The shortened time of GCT, PRP-CT, and PPP-CT may be associated with future thrombosis; 3. Evaluating the relationship between shortened GCT system time and overall tumor survival
Therefore, the GCT system evaluation may identify patients who are truly in a hypercoagulable state, providing monitoring indicators for subsequent anticoagulation; It can also be evaluated whether GCT time can reflect the prognosis of tumor patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal group | – | Diagnostic Test: CGT testGCT time within normal range；Normal coagulation function |
| hypercoagulable group | – | Diagnostic Test: CGT testGCT time reduction； Normal coagulation function, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- According to the commonly used Caprini Thrombosis Risk Score and Khrona Thrombosis Risk Score in clinical practice, patients with Caprini score ≥ 5 and Khrona score ≥ 2 have a VTE incidence rate of 8.8% -14.6%; The expected incidence of VTE in patients with shortened whole blood GCT time is 30%; Based on sample size calculation, Class I error α= 0.025, Class II error β= 0.05, bilateral test, loss of follow-up rate of 10%, calculated sample size of 76 cases. It is predicted that patients with shortened GCT time account for 30% of all tumor patients, and 254 patients need to complete GCT testing. Therefore, the overall sample size required for this study is 254 cases.
Key inclusion criteria (6 listed)
- Voluntarily participate and sign an informed consent form;
- Age ≥ 18 years old
- Expected survival time>6 months;
- Patients diagnosed with malignant tumors for the first time or progressing during treatment;
- Solid malignant tumors with clear pathological diagnosis;
Key exclusion criteria (5 listed)
- Patients with known venous thrombosis (including upper and lower limb venous thrombosis, Pulmonary embolism, visceral venous thrombosis, etc.);
- Patients who have received long-term treatment with Warfarin, Rivaroxaban, and low-molecular-weight heparin (except aspirin, hydrogen Clopidogrel, etc.);
- Patients with active infections and sepsis;
- Hematology tumor (except lymphoma);
- Patients who undergo any major surgical treatment within 28 days prior to enrollment;
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 |
|---|---|---|
| CGT testGCT、PRP-CT、PPP-CT monitor | Diagnostic test | Normal group, hypercoagulable group |
Primary outcome
Compared with non tumor patients, the GCT time of tumor patients is significantly GCT shortened in neoplames
Time frame: July 1,2023 to September 30,2024
Compared with non tumor patients, the GCT time of tumor patients is significantly shortened
1 secondary outcome
theincreased incidence of VTE
Time frame: July 1,2023 to September 30,2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: No. After completing the research thoroughly, apply for and obtain the consent of PI to access the data
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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. This study is not recruiting at the moment.
Zhang Jianning, Doctor principal investigator
Tianjin Medical University General 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 Neoplasm Metastasis and Blood Coagulation Disorder With Shortened Coagulation Time (Disorder), run by Tianjin Medical University General Hospital at 1 site in China.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Jul 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact donglai Jin, Doctor (862260363203, zyyjgb_ll@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compared with non tumor patients, the GCT time of tumor patients is significantly GCT shortened in neoplames (time frame: July 1,2023 to September 30,2024). 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 11 Jul 2023.