Visceral Venous ThrombosisThrombosisNCT07329725
Genetic Drivers,Risk Factors and Management Strategies on Survival and Clinical Outcomes in Visceral Venous "Thrombosis"
An observational study of Visceral Venous Thrombosis, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Visceral Venous Thrombosis
- What is being tested?
- Doppler ultrasonography
- How many people
- 101 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Dec 2025to 14 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- 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.
- Conditions
- Visceral Venous Thrombosis
- Being tested
- Doppler ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasonographyOther
Also called Chest-X ray, Electrocardiogram (ECG), Echocardiography if indicated., CT angiography
Radiological intervention Basic laboratory investigations, and Thrombophilia diagnosis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Doppler ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start14 Dec 2025
- Primary completion14 Dec 2026 (estimated)
- Study completion14 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Visceral Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 101 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma mohamed Ahmed Anwer, Sohag University
- Investigators
- Mahmoud I Yousef, Associate Prof., Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329725
- Sponsor's protocol ID
- Visceral Venous Thrombosis
- Acronym
- Thrombosis
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38592411Cohen 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.
PubMed 34116580
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Genetic Drivers, Acquired Risk Factors, and Management Strategies on Survival and Clinical Outcomes in Visceral Venous Thrombosis
- ClinicalTrials.gov ID
- NCT07329725
- Acronym / sponsor ID
- Thrombosis / Visceral Venous Thrombosis
- Conditions
- Visceral Venous Thrombosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 14 Dec 2025 (actual)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 14 Dec 2026 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort Analysis | – | Other: Doppler ultrasonographyReview 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 | – | Other: Doppler ultrasonographyConsecutive 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doppler ultrasonographyAlso: Chest-X ray, Electrocardiogram (ECG), Echocardiography if indicated., CT angiographyRadiological intervention Basic laboratory investigations, and Thrombophilia diagnosis | Other | Prospective Cohort Analysis, Retrospective Cohort Analysis |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Background: PubMed 38592411Boccatonda 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.
- Background: PubMed 34116580Cohen 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud I Yousef, Associate Prof. study chair
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visceral Venous Thrombosis, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07329725, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.