Application of a New Type of Whole Blood Coagulation Time Measurement in Evaluating the Hypercoagulable State of Malignant Tumors (GCTHCM)

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 Overview

• Status: Recruiting
• Conditions: Neoplasm Metastasis; Venous Thromboembolism; Blood Coagulation Disorder With Shortened Coagulation Time (Disorder)
• Intervention / Treatment: Diagnostic test: CGT test

• Study Type: Observational
• Enrollment (Estimated): 354

Contacts and Locations

• Study Contact: Name: donglai Jin, Doctor; Phone Number: 862260363203; Email: zyyjgb_ll@163.com
• Study Contact Backup: Name: Yi Wang, Doctor; Phone Number: 862260361044; Email: zyyjgb_ms@163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300170
      • Recruiting
      • Tianjin Medical University General Hospital
      • Contact: Qiong Qin, Doctor; Phone Number: 862260814993; Email: qinqiong315@tmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

1. Voluntarily participate and sign an informed consent form;
2. Age ≥ 18 years old
3. Expected survival time>6 months;
4. Patients diagnosed with malignant tumors for the first time or progressing during treatment;
5. Solid malignant tumors with clear pathological diagnosis;
6. ECOG physical fitness score ≤ 2 points

Exclusion Criteria:

1. Patients with known venous thrombosis (including upper and lower limb venous thrombosis, Pulmonary embolism, visceral venous thrombosis, etc.);
2. Patients who have received long-term treatment with Warfarin, Rivaroxaban, and low-molecular-weight heparin (except aspirin, hydrogen Clopidogrel, etc.);
3. Patients with active infections and sepsis;
4. Hematology tumor (except lymphoma);
5. Patients who undergo any major surgical treatment within 28 days prior to enrollment;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal group; GCT time within normal range；Normal coagulation function	Diagnostic test: CGT test; GCT、PRP-CT、PPP-CT monitor
hypercoagulable group; GCT time reduction； Normal coagulation function,	Diagnostic test: CGT test; GCT、PRP-CT、PPP-CT monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	July 1,2023 to September 30,2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
theincreased incidence of VTE	In patients with shortened GCT, the incidence of VTE increases.	July 1,2023 to September 30,2024

Collaborators and Investigators

• Sponsor: Tianjin Medical University General Hospital
• Investigators: Principal Investigator: Zhang Jianning, Doctor, Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: July 1, 2023
• First Submitted That Met QC Criteria: July 1, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 1, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Venous Thromboembolism; Neoplasm Metastasis; Blood Coagulation Disorder
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Embolism and Thrombosis; Neoplastic Processes; Neoplasms; Hemostatic Disorders; Blood Coagulation Disorders; Neoplasm Metastasis; Thromboembolism; Venous Thromboembolism; Thrombophilia
• Other Study ID Numbers: IRB2023-RTFL-134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: After completing the research thoroughly, apply for and obtain the consent of PI to access the data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No