Mediastinal DiseasesMED-HEMNCT05694806
Clinical Impact of Thoracic Scanographic Characteristics of Hematologic Malignancy Patients
An observational study of Mediastinal Diseases, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The mediastinum can be the site of benign or malignant tumors, including 10 to 20% of hematological malignancies. Mediastinal mass syndrome (MMS) includes symptoms due to irritation, invasion or compression of the organs of the mediastinum. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Mediastinal Diseases
- What is being tested?
- analysis of thoracic scans
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with eligibility criteria hospitalised during the study period 01/01/2014 - 31/12/2021
Who may be able to join
- Hematologic malignancy at diagnosis or relapse
- Symptomatic mediastinal mass syndrome
- Admission to the ICU, Continuous Medical Surveillance (CMS) or Intensive Care (IC) for symptomatology related to MMS
- Chest CT (after maximum 48 hours of corticosteroid therapy (1mg/kg/ Prednisone equivalent), maximum 15 days before and 5 days after admission to ICU)
- Maximum administration of corticosteroid therapy 48 hours before admission to the ICU (maximum 1mg/kg/ Prednisone equivalent)
- No prior pleural or pericardial drainage
- Study period: 01/01/2014 - 31/12/2021 (8 years)
Who cannot join
- No diagnosis of hematologic malignancy
- Diagnosis of solid benign or malignant tumor
- No mediastinal mass syndrome
- No admission to ICU/CMS
- No chest CT scan meeting inclusion criteria
- Administration of corticosteroids for more than 48 hours prior to admission to the ICU and/or prior to chest CT
- Lack of social security affiliation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Impact of Thoracic Scanographic Characteristics of Hematologic Malignancy Patients with Mediastinal Mass Syndrome Admitted to the Intensive Care Unit
The mediastinum can be the site of benign or malignant tumors, including 10 to 20% of hematological malignancies.
Mediastinal mass syndrome (MMS) includes symptoms due to irritation, invasion or compression of the organs of the mediastinum. This syndrome includes respiratory manifestations that may be secondary to compression of the tracheobronchial tree, venous vascular manifestations with the superior vena cava syndrome or arterial manifestations, cardiac manifestations, digestive or nervous manifestations.
Read more
The management of a mediastinal syndrome is a diagnostic and therapeutic emergency requiring the collaboration of several disciplines in order to achieve the most effective but least deleterious way possible to diagnostic imaging, etiological biopsy, and the possible implementation of life-saving symptomatic measures before the initiation of etiological treatment.
Diagnostic thoracic imaging relies primarily on thoracic computed tomography (CT) to determine the size and nature of the mediastinal mass, the presence and extent of tracheobronchial or great vessel compression, the presence of pleural and/or pericardial effusion, pulmonary embolism, parenchymal lesions, and possibly subdiaphragmatic lesions.
However, the potential severity of MMS is often under-diagnosed in adult patients, particularly in the context of hematologic malignancy. Indeed, we have very little literature on the initial management of these patients at risk.
The present study propose to conduct the first multicenter study to analyze the characteristics (clinical, scanographic, echocardiographic, hematological and resuscitation) of the initial management of patients with symptomatic MMS at diagnosis or at relapse of a patient with MH admitted to the Intensive Care Unit (ICU).
- Conditions
- Mediastinal Diseases
- Being tested
- analysis of thoracic scans
- Keywords
- Mediastinal mass syndrome
- Medical subject headings
- Mediastinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analysis of thoracic scansOther
analysis of thoracic scans realised in standard care
| Study group | Role | What they receive |
|---|---|---|
| patients with symptomatic Mediastinal mass syndrome | patients with symptomatic Mediastinal mass syndrome at diagnosis or at relapse of a patient with haematological malignancy admitted to the Intensive Care unit Receives: Other: analysis of thoracic scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify prognostic thoracic scan factors of severe mediastinal mass syndrome
To identify prognostic thoracic scan factors of severe mediastinal mass syndrome defined by the occurrence of severe respiratory, hemodynamics and/or neurological failures.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start1 Jun 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Retrospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muriel Picard, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694806
- Sponsor's protocol ID
- RC31/22/0237
- Acronym
- MED-HEM
- Status last verified
- Sep 2024
- First submitted
- 12 Jan 2023
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Thoracic Scanographic Characteristics of Hematologic Malignancy Patients with Mediastinal Mass Syndrome Admitted to the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05694806
- Acronym / sponsor ID
- MED-HEM / RC31/22/0237
- Conditions
- Mediastinal Diseases
- Keywords
- Mediastinal mass syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 23 Jan 2023 (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.
The mediastinum can be the site of benign or malignant tumors, including 10 to 20% of hematological malignancies.
Mediastinal mass syndrome (MMS) includes symptoms due to irritation, invasion or compression of the organs of the mediastinum. This syndrome includes respiratory manifestations that may be secondary to compression of the tracheobronchial tree, venous vascular manifestations with the superior vena cava syndrome or arterial manifestations, cardiac manifestations, digestive or nervous manifestations.
The management of a mediastinal syndrome is a diagnostic and therapeutic emergency requiring the collaboration of several disciplines in order to achieve the most effective but least deleterious way possible to diagnostic imaging, etiological biopsy, and the possible implementation of life-saving symptomatic measures before the initiation of etiological treatment.
Diagnostic thoracic imaging relies primarily on thoracic computed tomography (CT) to determine the size and nature of the mediastinal mass, the presence and extent of tracheobronchial or great vessel compression, the presence of pleural and/or pericardial effusion, pulmonary embolism, parenchymal lesions, and possibly subdiaphragmatic lesions.
However, the potential severity of MMS is often under-diagnosed in adult patients, particularly in the context of hematologic malignancy. Indeed, we have very little literature on the initial management of these patients at risk.
The present study propose to conduct the first multicenter study to analyze the characteristics (clinical, scanographic, echocardiographic, hematological and resuscitation) of the initial management of patients with symptomatic MMS at diagnosis or at relapse of a patient with MH admitted to the Intensive Care Unit (ICU).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with symptomatic Mediastinal mass syndrome | – | Other: analysis of thoracic scanspatients with symptomatic Mediastinal mass syndrome at diagnosis or at relapse of a patient with haematological malignancy admitted to the Intensive Care unit |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with eligibility criteria hospitalised during the study period 01/01/2014 - 31/12/2021
Key inclusion criteria (7 listed)
- Hematologic malignancy at diagnosis or relapse
- Symptomatic mediastinal mass syndrome
- Admission to the ICU, Continuous Medical Surveillance (CMS) or Intensive Care (IC) for symptomatology related to MMS
- Chest CT (after maximum 48 hours of corticosteroid therapy (1mg/kg/ Prednisone equivalent), maximum 15 days before and 5 days after admission to ICU)
- Maximum administration of corticosteroid therapy 48 hours before admission to the ICU (maximum 1mg/kg/ Prednisone equivalent)
Key exclusion criteria (7 listed)
- No diagnosis of hematologic malignancy
- Diagnosis of solid benign or malignant tumor
- No mediastinal mass syndrome
- No admission to ICU/CMS
- No chest CT scan meeting inclusion criteria
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 |
|---|---|---|
| analysis of thoracic scansanalysis of thoracic scans realised in standard care | Other | patients with symptomatic Mediastinal mass syndrome |
Primary outcome
To identify prognostic thoracic scan factors of severe mediastinal mass syndrome
Time frame: 1 week
To identify prognostic thoracic scan factors of severe mediastinal mass syndrome defined by the occurrence of severe respiratory, hemodynamics and/or neurological failures.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Muriel Picard, MD principal investigator
University Hospital, Toulouse
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 Mediastinal Diseases, run by University Hospital, Toulouse at 1 site in France.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Sep 2024. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muriel Picard, MD (0561756105 ext. +33, picard.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify prognostic thoracic scan factors of severe mediastinal mass syndrome (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2024.