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

NCT ID: NCT07329725

Last Updated: 2026-01-09

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

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-14

Study Completion Date

2026-12-14

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Visceral Venous Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

Doppler ultrasonography

Intervention Type OTHER

Radiological intervention Basic laboratory investigations, and 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.

Doppler ultrasonography

Intervention Type OTHER

Radiological intervention Basic laboratory investigations, and Thrombophilia diagnosis

Interventions

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Doppler ultrasonography

Radiological intervention Basic laboratory investigations, and Thrombophilia diagnosis

Intervention Type OTHER

Other Intervention Names

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

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Fatma mohamed Ahmed Anwer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud I Yousef, Associate Prof.

Role: STUDY_CHAIR

Sohag University

Locations

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Sohag University

Sohag, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 38592411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34116580 (View on PubMed)

Other Identifiers

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Visceral Venous Thrombosis

Identifier Type: -

Identifier Source: org_study_id

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