Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07329725

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag University

Sohag, 82511, Egypt

About this study

Observational study (hybrid study comprising a retrospective and prospective cohort analysis):

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.

Data will be collected from the Department of Internal Medicine/hematology unit at Sohag University hospital and clinical databases.

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.

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Doppler ultrasonography

Other

Radiological intervention Basic laboratory investigations, and Thrombophilia diagnosis

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

Primary outcomes

  1. Patients diagnosed with visceral venous thrombosis

    Time frame: 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.

    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.

Secondary outcomes

  1. Frequency and distribution

    Time frame: 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.

    To estimate the frequency of somatic mutations and inherited thrombophilias and describe their distribution across anatomical sites of VVT (portal, mesenteric, renal, splenic, hepatic) and underlying etiologies (autoimmune, inflammation, cirrhosis, malignancy, post-surgery, idiopathic).

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Acronym: Thrombosis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.