Hypercoagulation Screening in Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

16000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

There is a complex, mutual relationship between cancer and thrombosis. Indeed, the tumor has the capacity to activate the hemostatic system and this leads to an increased thrombotic risk in cancer patients. Even in the absence of clinical manifestations, cancer patients are commonly characterized by hemostatic abnormalities, recognized only by laboratory testing, which define the 'hypercoagulable state'. Of interest, hypercoagulation has been repeatedly reported to be associated with tumor progression and poor prognosis in various carcinomas. On the other hand, thrombotic event can represent the first signal of the presence of an occult tumor. These findings suggest that the coagulant pathway might play a role in the preclinical phase of cancer. The investigators hypothesize that a persistent, subclinical activation of the hemostatic system in an otherwise healthy subject, may predispose not only to thrombosis, but also to tumor formation and spreading. A major problem in primary cancer prevention is the lack of effective predictive markers of the disease. The HYPERCAN is an ongoing prospective Italian multicenter study organized around two tightly-interconnected research programs aiming to: 1\_the assessment of thrombotic markers as a tool for cancer risk prediction in two large populations of healthy subjects, i.e. a group of healthy blood donors of Bergamo and Milano Provinces and a subgroup of Moli-sani subjects of the Molise region; and 2\_ the evaluation whether thrombotic markers and/or the occurrence of overt thrombosis (or disseminated intravascular coagulation) may be prognostic of cancer disease outcomes (i.e. overall survival, progression free survival in metastatic cancer, disease free survival in limited disease) in cancer patients with different types of solid tumors (i.e. breast, lung and gastrointestinal cancers).

Therefore, the assessment of cancer risk occurrence in healthy individuals might be useful for anticipation of cancer diagnosis. In addition, the results of this study might help to evaluate whether thrombotic markers may be prognostic of cancer outcomes independently of the disease extension.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Thrombin Generation and Prediction of Thromboembolic Events in Oncology Patients At Risk

NCT06051214

Solid Carcinoma

RECRUITING NA

Detecting Abnormal Blood Clotting in Patients With Metastatic Cancer Undergoing Surgery

NCT00096590

Thromboembolism Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED

Hypercoagulability and Thromboembolic Risk in Patients With Malignant Disease, Evaluated by Thrombelastograph (TEG®)

NCT00400504

Cancer

UNKNOWN

Evaluation of Fibrin Structure Marker in Cancer Patients Treated and Not Treated With LMWH

NCT02552381

Malignant Tumor

COMPLETED

Analysis of Circulating Tumor Markers in Blood

NCT04025541

Cancer Breast Cancer Sarcoma +3 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Blood Donors Moli-sani Subjects Cancer Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy blood donors

10,000 highly controlled blood donors in the age range 30-70 years

No interventions assigned to this group

Moli-sani subjects

A sample of 1,000 tumor cases have been identified so far and samples from these participants will be analyzed compared to 1,000 controls from randomly extracted from the Moli-sani cohort (parent cohort).

No interventions assigned to this group

Cancer patients

4,000 Patients with breast, lung, and gastrointestinal tumors.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* good health
* signed informed consent.

* with life expectation higher than 3 months;
* patients with breast, lung or gastrointestinal tumors candidated for chemotherapy regimen;
* ECOG PS 0-2;
* adeguate bone marrow and renal function;
* signed informed consent.

Exclusion Criteria

* inflammations/infections/fever;
* recent vaccinations;
* recent surgery;
* anticoagulant therapy.

Cancer patients\_

* acute medical illness;
* terminal conditions or life expectancy less than 3 months;
* under low molecular weight heparin at therapeutic dosage.

Eligible Sex

ALL

Accepts Healthy Volunteers

No