Genetic Drivers,Risk Factors and Management Strategies on Survival and Clinical Outcomes in Visceral Venous "Thrombosis"

NCT07329725 | Active Not Recruiting

• 1 other identifier: Visceral Venous Thrombosis
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the impact of genetic drivers (somatic and inherited thrombophilias), acquired risk factors, and management strategies on survival and clinical outcomes in patients with VVT using a hybrid prospective-retrospective cohort design.

Conditions

Visceral Venous Thrombosis

Outcome Measures

Primary Outcomes (1)

• Patients diagnosed with visceral venous thrombosis

  To evaluate the impact of genetic drivers (somatic and inherited thrombophilias), acquired risk factors, and management strategies on survival and clinical outcomes in patients with VVT using a hybrid prospective-retrospective cohort design.

  The retrospective component will include eligible patients diagnosed within the preceding ten years, whereas the prospective component will enroll newly diagnosed patients and follow them for one year.

Secondary Outcomes (1)

• Frequency and distribution

  The retrospective component will include eligible patients diagnosed within the preceding ten years, whereas the prospective component will enroll newly diagnosed patients and follow them for one year.

Study Arms (2)

Retrospective Cohort Analysis

Review of medical records to analyze demographic, clinical, and molecular data. Assessment of treatment regimens and outcomes, including thrombotic events, disease progression, and survival rates.

Other: Doppler ultrasonography

Prospective Cohort Analysis

Consecutive patients will be diagnosed with VVT from \[date of ethical approval\] forward, enrolled at diagnosis and followed prospectively with standardized baseline testing (including comprehensive genetic panel) and predefined follow-up visits.

Other: Doppler ultrasonography

Interventions

Doppler ultrasonography OTHER

Radiological intervention Basic laboratory investigations, and Thrombophilia diagnosis

Also known as: Chest-X ray, Electrocardiogram (ECG), Echocardiography if indicated., CT angiography, MR venography, Doppler of the limbs, Basic laboratory investigations, Thrombophilia diagnosis

Prospective Cohort Analysis; Retrospective Cohort Analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with visceral venous thrombosis, including portal, mesenteric, splenic, renal and hepatic vein thrombosis in Department of Internal Medicine, Sohag University Hospital.

You may qualify if:

• Adult patients (≥ 18 years) with radiologically confirmed visceral venous thrombosis.
• Availability of complete clinical, laboratory, and imaging data at diagnosis.
• Patients who consent to participate and provide blood samples for genetic testing.

You may not qualify if:

• Isolated lower-limb deep-vein thrombosis or pulmonary embolism without visceral involvement.
• Patients with incomplete records precluding outcome assessment.
• Refusal or inability to provide informed consent
• Patients lost to follow-up within the first three months of diagnosis.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, 82511, Egypt

Location

Related Publications (2)

• Boccatonda A, Gentilini S, Zanata E, Simion C, Serra C, Simioni P, Piscaglia F, Campello E, Ageno W. Portal Vein Thrombosis: State-of-the-Art Review. J Clin Med. 2024 Mar 6;13(5):1517. doi: 10.3390/jcm13051517.

  PMID: 38592411 BACKGROUND

• Cohen O, Caiano LM, Tufano A, Ageno W. Cancer-Associated Splanchnic Vein Thrombosis. Semin Thromb Hemost. 2021 Nov;47(8):931-941. doi: 10.1055/s-0040-1722607. Epub 2021 Jun 11.

  PMID: 34116580 BACKGROUND

MeSH Terms

Interventions

Ultrasonography, Doppler, Transcranial; X-Rays

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Mahmoud I Yousef, Associate Prof.

  Sohag University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 9, 2026
• Study Start: December 14, 2025
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): December 14, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

EG (1)