Pleural Mesothelioma MalignantMESORTIBONCT06637345
Identification of Prognostic and Predictive Biomarkers of Toxicity in Patients With Malignant Pleural Mesothelioma and Treated With High Doses of Radiotherapy (MESORTIBO)
An observational study of Pleural Mesothelioma Malignant, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial summary
Malignant pleural mesothelioma (MPM) is a tumour that originates from the pleural layers (visceral and parietal) that envelop the lungs and the inner wall of the thoracic cage. In other tumour contexts, numerous studies have demonstrated a synergistic effect between RT and Immune Checkpoint Inhibitors (ICIs), mainly… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Mesothelioma Malignant
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2024to 15 Mar 2027
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with non-metastatic MPM previously treated with chemotherapy, undergoing a non-radical long-sparing surgical approach and treated with RT with radical intent (retrospective cohort) or eligible for RT with radical intent (prospective cohort)
Who may be able to join
- Over 18 years of age;
- Ability to understand, accept and sign consent informed;
- Histological diagnosis of malignant pleural mesothelioma;
- Previous administration of chemotherapy;
- Previous non-radical surgical approach (diagnostic thoracoscopy or R1-R2 surgery);
- Subject eligible for or already treated with RT on hemithorax for radical purposes (50 Gy in fractions on hemithorax + possible boost 60 Gy on residual PET+)
Who cannot join
- Disease not histologically established
- Progression pattern not amenable to radiation treatment (ipsilateral or metastatic intrathoracic extensive disease);
- Metastatic patient at diagnosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
Aviano, Pordenone, 33081
Alberto Revelant, MD, 0434 659 159, alberto.revelant@cro.it
Alberto Revelant, MD
About this study
Malignant pleural mesothelioma (MPM) is a tumour that originates from the pleural layers (visceral and parietal) that envelop the lungs and the inner wall of the thoracic cage.
In other tumour contexts, numerous studies have demonstrated a synergistic effect between RT and Immune Checkpoint Inhibitors (ICIs), mainly due to immunogenic effects attributed to high doses of RT and ICIs-mediated activation of anti-tumour T lymphocytes.
Read more
Both treatments, RT and immunotherapy, have demonstrated a survival advantage in MPM, but are associated with non-negligible pulmonary toxicity. Therefore, the combination of these 2 therapeutic approaches requires a careful assessment of risk factors for the occurrence of toxicity. The identification of circulating biomarkers capable of predicting the onset of severe toxicity induced by radical radiation treatment is an important clinical need in MPM.
This study aims to monitor circulating biomarkers, such as molecules involved in inflammation and oxidative stress and cellular effectors modulated by radiation treatment and potentially associated with the development of toxicity and/or markers of an immunogenic effect of radiotherapy in the peripheral blood of subjects with malignant pleural mesothelioma for treatment with radical hemithoracic radiotherapy.
Read the detailed description
Malignant pleural mesothelioma (MPM) is a tumour that originates from the pleural layers (visceral and parietal) that envelop the lungs and the inner wall of the thoracic cage.
In other tumour contexts, numerous studies have demonstrated a synergistic effect between RT and Immune Checkpoint Inhibitors (ICIs), mainly due to immunogenic effects attributed to high doses of RT and ICIs-mediated activation of anti-tumour T lymphocytes.
Both treatments, RT and immunotherapy, have demonstrated a survival advantage in MPM, but are associated with non-negligible pulmonary toxicity. Therefore, the combination of these 2 therapeutic approaches requires a careful assessment of risk factors for the occurrence of toxicity. The identification of circulating biomarkers capable of predicting the onset of severe toxicity induced by radical radiation treatment is an important clinical need in MPM.
This study aims to monitor circulating biomarkers, such as molecules involved in inflammation and oxidative stress and cellular effectors modulated by radiation treatment and potentially associated with the development of toxicity and/or markers of an immunogenic effect of radiotherapy in the peripheral blood of subjects with malignant pleural mesothelioma for treatment with radical hemithoracic radiotherapy.
- Conditions
- Pleural Mesothelioma Malignant
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | Patients treated with RT with radical intent from 01 January 2014 to the date of study approval | |
| Prospective cohort | Patients eligible for radical intent radiotherapy treatment radical, from the date of study approval |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between biomarker levels measured at the end of radiation treatment and pulmonary toxicity of grade ≥2 associated with RT developed as an acute (within 6 months) or late (after 6 months) event
Differences in fold change of selected biomarkers, between subjects experiencing or not experiencing acute or late toxicity
Measured: up to 36 months
Secondary outcomes (6)
Relation between the severity of radio-induced toxicity and trend of biomarkers associated with it
Evaluation of linear trend of biomarkers fold change in relation with toxicity severity
Measured: up to 36 months
Identifying biomarkers associated with lung toxicity potentially predictive of pulmonary fibrosis
Difference in frequencies of selected biomarkers between subgroups of patients with or without pulmonary fibrosis
Measured: up to 36 months
Identifying signs of radio-induced immunomodulation among significant changes induced by hemithoracic radical radiotherapy in analysed biomarkers
difference in median values of selected biomarkers before and after treatment
Measured: up to 36 months
Association between the levels of biomarkers measured at the end of treatment radiation and overall survival (OS) at 24 months
Relation between overall survival and levels of biomarkers fold change using Cox regression. OS will be defined as time from beginning of the therapy until death from any cause or end of follow-up, whichever comes first.
Measured: 24 moths after end of treatment
To assess the prognostic potential of basal levels of analysed biomarkers
Relation between OS and pretreatment levels of selected biomarkers. Levels of biomarkers will be dichotomized based on pretreatment median value. Kaplan-Meier method and log rank test will be used. OS will be defined as time from beginning of the therapy until death from any cause or end of follow-up, whichever comes first.
Measured: up to 36 months
Association between the levels of biomarkers variation (between baseline and treatment end) and Progression Free Survival (PFS) at 12 months
Relation between PFS and levels of biomarkers fold change compared to pre-treatment value. PFS will be defined as time from beginning of the therapy until objective PD, death or end of follow-up, whichever comes first.
Measured: 12 months after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Mar 2024
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural Mesothelioma MalignantStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alberto Revelant, MD, Principal investigator, Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637345
- Sponsor's protocol ID
- CRO-2023-63
- Acronym
- MESORTIBO
- Status last verified
- Sep 2024
- First submitted
- 3 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Prognostic and Predictive Biomarkers of Toxicity in Patients With Malignant Pleural Mesothelioma and Treated With High Doses of Radiotherapy (MESORTIBO)
- ClinicalTrials.gov ID
- NCT06637345
- Acronym / sponsor ID
- MESORTIBO / CRO-2023-63
- Conditions
- Pleural Mesothelioma Malignant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 15 Oct 2024 (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.
Malignant pleural mesothelioma (MPM) is a tumour that originates from the pleural layers (visceral and parietal) that envelop the lungs and the inner wall of the thoracic cage.
In other tumour contexts, numerous studies have demonstrated a synergistic effect between RT and Immune Checkpoint Inhibitors (ICIs), mainly due to immunogenic effects attributed to high doses of RT and ICIs-mediated activation of anti-tumour T lymphocytes.
Both treatments, RT and immunotherapy, have demonstrated a survival advantage in MPM, but are associated with non-negligible pulmonary toxicity. Therefore, the combination of these 2 therapeutic approaches requires a careful assessment of risk factors for the occurrence of toxicity. The identification of circulating biomarkers capable of predicting the onset of severe toxicity induced by radical radiation treatment is an important clinical need in MPM.
This study aims to monitor circulating biomarkers, such as molecules involved in inflammation and oxidative stress and cellular effectors modulated by radiation treatment and potentially associated with the development of toxicity and/or markers of an immunogenic effect of radiotherapy in the peripheral blood of subjects with malignant pleural mesothelioma for treatment with radical hemithoracic radiotherapy.
Detailed description
Malignant pleural mesothelioma (MPM) is a tumour that originates from the pleural layers (visceral and parietal) that envelop the lungs and the inner wall of the thoracic cage.
In other tumour contexts, numerous studies have demonstrated a synergistic effect between RT and Immune Checkpoint Inhibitors (ICIs), mainly due to immunogenic effects attributed to high doses of RT and ICIs-mediated activation of anti-tumour T lymphocytes.
Both treatments, RT and immunotherapy, have demonstrated a survival advantage in MPM, but are associated with non-negligible pulmonary toxicity. Therefore, the combination of these 2 therapeutic approaches requires a careful assessment of risk factors for the occurrence of toxicity. The identification of circulating biomarkers capable of predicting the onset of severe toxicity induced by radical radiation treatment is an important clinical need in MPM.
This study aims to monitor circulating biomarkers, such as molecules involved in inflammation and oxidative stress and cellular effectors modulated by radiation treatment and potentially associated with the development of toxicity and/or markers of an immunogenic effect of radiotherapy in the peripheral blood of subjects with malignant pleural mesothelioma for treatment with radical hemithoracic radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | –Patients treated with RT with radical intent from 01 January 2014 to the date of study approval |
| Prospective cohort | – | –Patients eligible for radical intent radiotherapy treatment radical, from the date of study approval |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with non-metastatic MPM previously treated with chemotherapy, undergoing a non-radical long-sparing surgical approach and treated with RT with radical intent (retrospective cohort) or eligible for RT with radical intent (prospective cohort)
Key inclusion criteria (6 listed)
- Over 18 years of age;
- Ability to understand, accept and sign consent informed;
- Histological diagnosis of malignant pleural mesothelioma;
- Previous administration of chemotherapy;
- Previous non-radical surgical approach (diagnostic thoracoscopy or R1-R2 surgery);
Key exclusion criteria (3 listed)
- Disease not histologically established
- Progression pattern not amenable to radiation treatment (ipsilateral or metastatic intrathoracic extensive disease);
- Metastatic patient at diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between biomarker levels measured at the end of radiation treatment and pulmonary toxicity of grade ≥2 associated with RT developed as an acute (within 6 months) or late (after 6 months) event
Time frame: up to 36 months
Differences in fold change of selected biomarkers, between subjects experiencing or not experiencing acute or late toxicity
6 secondary outcomes
Relation between the severity of radio-induced toxicity and trend of biomarkers associated with it
Time frame: up to 36 months
Identifying biomarkers associated with lung toxicity potentially predictive of pulmonary fibrosis
Time frame: up to 36 months
Identifying signs of radio-induced immunomodulation among significant changes induced by hemithoracic radical radiotherapy in analysed biomarkers
Time frame: up to 36 months
Association between the levels of biomarkers measured at the end of treatment radiation and overall survival (OS) at 24 months
Time frame: 24 moths after end of treatment
To assess the prognostic potential of basal levels of analysed biomarkers
Time frame: up to 36 months
Association between the levels of biomarkers variation (between baseline and treatment end) and Progression Free Survival (PFS) at 12 months
Time frame: 12 months after end of treatment
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 15 Oct 2024.
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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.
Alberto Revelant, MD principal investigator
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
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 Pleural Mesothelioma Malignant, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 15 Oct 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 Italy. 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?
Contact Alberto Revelant, MD (0434 659 159, alberto.revelant@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between biomarker levels measured at the end of radiation treatment and pulmonary toxicity of grade ≥2 associated with RT developed as an acute (within 6 months) or late (after 6 months) event (time frame: up to 36 months). 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 15 Oct 2024.