Clinical, Radiological, Tissue and Biological Phenotyping for the Analysis of the Transition From Physiology to Pathology in Pulmonary Diseases With Pulmonary Hypertension

NCT ID: NCT07184671

Last Updated: 2025-09-22

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

NOT_YET_RECRUITING

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-09-30

Brief Summary

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This is a monocentric, case-control, comparative study aiming at investigating the transition from physiological to pathological pulmonary circulation in patients with pulmonary hypertension (PH) and chronic lung diseases. The study will include 105 adults participants undergoing lung surgery, divided into three groups, Group A (patients with chronic lung disease and PH undergoing lung transplantation), Group B (patients with chronic lung disease without PH), and Group C (patients without chronic lung disease nor PH). The primary objective is to identify the association between vascular remodeling and PH by measuring the medial thickness of pulmonary arteries. Secondary objectives include multimodal phenotyping (clinical, radiological, tissue, and biological) to explore mechanisms of PH development. Blood, broncho-alveolar lavage, and lung tissue samples will be collected during routine care. The study aims to improve understanding of PH pathophysiology and identify potential biomarkers and therapeutic targets.

Detailed Description

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Conditions

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Pulmonary Hypertension Chronic Pulmonary Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with chronic pulmonary disease and pulmonary hypertension

Patients on the lung transplant list with chronic pulmonary disease and pulmonary hypertension

blood sampling

Intervention Type BIOLOGICAL

22mL peripheral blood will be collected

broncho-alveolar lavage sampling

Intervention Type BIOLOGICAL

Collected on resected tissue

lung parenchyma sampling

Intervention Type BIOLOGICAL

Collected on resected tissue

Control patients with chronic pulmonary disease without pulmonary hypertension

Control patients with chronic pulmonary disease without pulmonary hypertension on the lung transplant list or with an indication for lung resection surgery for diagnostic or therapeutic purposes.

blood sampling

Intervention Type BIOLOGICAL

22mL peripheral blood will be collected

broncho-alveolar lavage sampling

Intervention Type BIOLOGICAL

Collected on resected tissue

lung parenchyma sampling

Intervention Type BIOLOGICAL

Collected on resected tissue

Control patients without chronic pulmonary disease or pulmonary hypertension

Control patients without chronic pulmonary disease or pulmonary hypertension with an indication for lung resection.

blood sampling

Intervention Type BIOLOGICAL

22mL peripheral blood will be collected

broncho-alveolar lavage sampling

Intervention Type BIOLOGICAL

Collected on resected tissue

lung parenchyma sampling

Intervention Type BIOLOGICAL

Collected on resected tissue

Interventions

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blood sampling

22mL peripheral blood will be collected

Intervention Type BIOLOGICAL

broncho-alveolar lavage sampling

Collected on resected tissue

Intervention Type BIOLOGICAL

lung parenchyma sampling

Collected on resected tissue

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Male or female over 18 years of age
2. Patient who has received information about the study and has not expressed any objection
3. Patient who is a beneficiary or entitled person under a social security scheme
4. Patient requiring thoracic surgery for an acute or chronic acquired pathology with planned resection of lung parenchyma.
5. Group A: patients on the lung transplant list with chronic lung disease and pulmonary hypertension\*.

Group B: control patients with chronic lung disease without pulmonary hypertension on the lung transplant list or with an indication for lung resection surgery for diagnostic or therapeutic purposes.

Group C: control patients without chronic lung disease or pulmonary hypertension with an indication for lung resection.

\*Pulmonary hypertension is defined by a mean resting pulmonary arterial pressure of 20 mmHg and pulmonary vascular resistances \> 2UW and an occlusion pulmonary arterial pressure ≤ 15 mmHg.

Exclusion Criteria

1. Person in exclusion period from another research protocol at the time the no-objection is collected
2. Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship or trusteeship, patients deprived of their liberty, pregnant or breast-feeding women).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2025-A00420-49

Identifier Type: -

Identifier Source: org_study_id

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