NeoplasmsTRANSPROUSTNCT06826066
Involvement of the Immune System in Intrinsic Radiosensitivity
A study testing Blood samples in people with Neoplasms, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Radiotherapy is one of the major treatments for cancer. It may be indicated in more than two-thirds of patients, regardless of cancer location or disease stage. The mechanisms of radiotherapy action are numerous: halting tumor proliferation, inducing tumor cell death, triggering anti-tumor immune responses, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 12 May 2025to 12 May 2027
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years
- Patients who have been treated with radiotherapy
- Absence of toxicity grade 2 or higher
- Patients without psychiatric, sociological, family, or geographical difficulties that could interfere with patient compliance to the protocol or follow-up
- Information and signed informed consent
- Affiliated with social security
Who cannot join
- Inability to obtain patient consent
- Patient refusing blood sample collection
- Patient deprived of liberty or under legal protection (under guardianship, under curatorship)
- Patients who have experienced radiation-induced toxicity of grade 2 or higher
- Disease progression, relapse
- Patient under State Medical Aid
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Henri Mondor, 1 rue Gustave Eiffel,
Créteil, Île-de-France Region, 94000
About this study
Radiotherapy is one of the major treatments for cancer. It may be indicated in more than two-thirds of patients, regardless of cancer location or disease stage. The mechanisms of radiotherapy action are numerous: halting tumor proliferation, inducing tumor cell death, triggering anti-tumor immune responses, and ensuring both local and systemic tumor control. As a result, current treatments are highly effective, providing, for instance, a 5-year overall survival rate of about 90%-95% for localized breast and prostate cancers.
Read the detailed description
In everyday clinical practice, the indications for radiotherapy are based on the benefit-to-risk ratio concerning toxicity. In most cases, radiotherapy causes mild to moderate acute or late side effects, depending on the patient and the volumes irradiated. However, in 1% to 5% of treated patients, these side effects can be severe, unexpected, and often unexplained. The cause of this toxicity remains poorly understood and largely unexplored, especially concerning the intrinsic radiosensitivity of patients.
The PROUST study (French Registry for Review of Morbidity and Mortality; RMM) was initiated in France to prospectively collect clinical, dosimetric, and biological data on individual radiosensitivity in patients who experience severe radiation-induced toxicity. The goal of this study is to better characterize patients with severe radiation-induced toxicities and identify the cellular factors involved in this toxicity.
Although the aim is to identify the cellular and molecular immune factors involved in severe radiation-induced toxicity, we currently cannot determine whether the immune monitoring observed in radiosensitive patients is a consequence of the toxicity itself or of radiotherapy. To answer this question, we have decided to create a control cohort, called TRANSPROUST, which includes patients treated with radiotherapy but who did not experience severe radiation-induced toxicity. After obtaining consent from patients who were treated with radiotherapy but did not develop severe toxicity, we will collect blood samples similar to those taken from the severe toxicity cohort.
These samples will undergo flow cytometry analysis, and the results will be compared with those of patients included in the PROUST cohort.
- Conditions
- Neoplasms
- Being tested
- Blood samples
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
We propose to include patients who have been treated with radiotherapy and did not experience severe radiation-induced toxicity, after obtaining their informed consent. A blood sample will then be collected by the nursing staff from the Oncology-Radiotherapy department at Henri Mondor University Hospital. After the patient signs the consent form, each patient will have their clinical information recorded and a blood sample taken. The blood samples will be immediately transported, at room temperature, to the INSERM U955 i-Biot unit at Henri Mondor (serum, plasma, and PBMC). All samples will be frozen at -80°C for later analysis.
| Study group | Role | What they receive |
|---|---|---|
| TRANSPROUST is a prospective, single-center cohort. | Experimental | Not described Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify immunological markers predictive of intrinsic radiosensitivity.
Identification of immunological markers predictive of intrinsic radiosensitivity using flow cytometry analysis
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start12 May 2025
- Primary completion12 May 2027 (estimated)
- Study completion12 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826066
- Sponsor's protocol ID
- APHP240671
- Acronym
- TRANSPROUST
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATA IS OWNED BY ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of the Immune System in Intrinsic Radiosensitivity
- ClinicalTrials.gov ID
- NCT06826066
- Acronym / sponsor ID
- TRANSPROUST / APHP240671
- Conditions
- Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 12 May 2027 (estimated)
- Study completion
- 12 May 2027 (estimated)
- First posted
- 13 Feb 2025 (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.
Radiotherapy is one of the major treatments for cancer. It may be indicated in more than two-thirds of patients, regardless of cancer location or disease stage. The mechanisms of radiotherapy action are numerous: halting tumor proliferation, inducing tumor cell death, triggering anti-tumor immune responses, and ensuring both local and systemic tumor control. As a result, current treatments are highly effective, providing, for instance, a 5-year overall survival rate of about 90%-95% for localized breast and prostate cancers.
Detailed description
In everyday clinical practice, the indications for radiotherapy are based on the benefit-to-risk ratio concerning toxicity. In most cases, radiotherapy causes mild to moderate acute or late side effects, depending on the patient and the volumes irradiated. However, in 1% to 5% of treated patients, these side effects can be severe, unexpected, and often unexplained. The cause of this toxicity remains poorly understood and largely unexplored, especially concerning the intrinsic radiosensitivity of patients.
The PROUST study (French Registry for Review of Morbidity and Mortality; RMM) was initiated in France to prospectively collect clinical, dosimetric, and biological data on individual radiosensitivity in patients who experience severe radiation-induced toxicity. The goal of this study is to better characterize patients with severe radiation-induced toxicities and identify the cellular factors involved in this toxicity.
Although the aim is to identify the cellular and molecular immune factors involved in severe radiation-induced toxicity, we currently cannot determine whether the immune monitoring observed in radiosensitive patients is a consequence of the toxicity itself or of radiotherapy. To answer this question, we have decided to create a control cohort, called TRANSPROUST, which includes patients treated with radiotherapy but who did not experience severe radiation-induced toxicity. After obtaining consent from patients who were treated with radiotherapy but did not develop severe toxicity, we will collect blood samples similar to those taken from the severe toxicity cohort.
These samples will undergo flow cytometry analysis, and the results will be compared with those of patients included in the PROUST cohort.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRANSPROUST is a prospective, single-center cohort. | Experimental | Other: Blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Patients who have been treated with radiotherapy
- Absence of toxicity grade 2 or higher
- Patients without psychiatric, sociological, family, or geographical difficulties that could interfere with patient compliance to the protocol or follow-up
- Information and signed informed consent
Key exclusion criteria (6 listed)
- Inability to obtain patient consent
- Patient refusing blood sample collection
- Patient deprived of liberty or under legal protection (under guardianship, under curatorship)
- Patients who have experienced radiation-induced toxicity of grade 2 or higher
- Disease progression, relapse
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 |
|---|---|---|
| Blood samplesWe propose to include patients who have been treated with radiotherapy and did not experience severe radiation-induced toxicity, after obtaining their informed consent. A blood sample will then be collected by the nursing staff from the Oncology-Radiotherapy department at Henri Mondor University Hospital. After the patient signs the consent form, each patient will have their clinical information recorded and a blood sample taken. The blood samples will be immediately transported, at room temperature, to the INSERM U955 i-Biot unit at Henri Mondor (serum, plasma, and PBMC). All samples will be frozen at -80°C for later analysis. | Other | TRANSPROUST is a prospective, single-center cohort. |
Primary outcome
Identify immunological markers predictive of intrinsic radiosensitivity.
Time frame: 48 hours
Identification of immunological markers predictive of intrinsic radiosensitivity using flow cytometry analysis
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 Jan 2026.
- Individual participant dataSharing planned: No. DATA IS OWNED BY ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Neoplasms, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 6 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 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 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?
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 BELKACIMI Mr Yazid, PhD (01 49 81 45 22 ext. + 33, yazid.belkacemi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify immunological markers predictive of intrinsic radiosensitivity. (time frame: 48 hours). 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 Jan 2026.