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

January 6, 2026 updated by: Fatma mohamed Ahmed Anwer, Sohag University

Impact of Genetic Drivers, Acquired 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

  1. 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.

  2. 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.

Study Type

Observational

Enrollment (Estimated)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt, 82511
        • Sohag University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Radiological intervention Basic laboratory investigations, and Thrombophilia diagnosis
Other Names:
  • Electrocardiogram (ECG)
  • Chest-X ray
  • Echocardiography if indicated.
  • CT angiography
  • MR venography
  • Doppler of the limbs
  • Basic laboratory investigations
  • Thrombophilia diagnosis
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
Radiological intervention Basic laboratory investigations, and Thrombophilia diagnosis
Other Names:
  • Electrocardiogram (ECG)
  • Chest-X ray
  • Echocardiography if indicated.
  • CT angiography
  • MR venography
  • Doppler of the limbs
  • Basic laboratory investigations
  • Thrombophilia diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Study Chair: Mahmoud I Yousef, Associate Prof., Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2025

Primary Completion (Estimated)

December 14, 2026

Study Completion (Estimated)

December 14, 2026

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Visceral Venous Thrombosis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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