Cancer ChildhoodCluPPFeNNCT05584930
Clusterin, Ptx3 and Pediatric Febrile Neutropenia (CluPPFeN)
A study testing Collection of blood sample in people with Cancer Childhood and Febrile Neutropenia, run by University Hospital, Angers at 1 site in France.
Trial summary
Febrile aplasia is a common occurrence in children/adults treated with chemotherapy for malignant blood diseases or solid cancers. This acquired deficiency of immunity mainly causes susceptibility to bacterial and fungal infections, pathogens normally recognized by specific receptors of innate immunity (Pattern… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cancer Childhood, Febrile Neutropenia
- What is being tested?
- Collection of blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2022to 6 Aug 2024
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Child under 18 years
- Hospitalized for chemotherapy leading to febrile aplasia
- Signature of the informed consent of the parents or holder of parental authority and consent of the patient
Who cannot join
- Expected non aplasing chemotherapy
- Child with less than 5 kg body weight at inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Serum Clusterin and Serum PTX3 Assay During Febrile Aplasia in Children Treated in Pediatric Oncology
Febrile aplasia is a common occurrence in children/adults treated with chemotherapy for malignant blood diseases or solid cancers.
This acquired deficiency of immunity mainly causes susceptibility to bacterial and fungal infections, pathogens normally recognized by specific receptors of innate immunity (Pattern Recognition Receptor, PRR).
Read more
Thus, the febrile episodes in the context of post-chemotherapy neutropenia can be bacterial or fungal etiology, but can also frequently be related to viral infections, toxic phenomena or other etiologies. In the absence of a discriminating marker, treatment for all these children is based on early, broad-spectrum antibiotic therapy in hospital. Septic shock or even death by refractory septic shock remain, even if they are rare, real complications in pediatric oncology, requiring discriminatory markers for effective management, While trying to reduce the number and duration of hospitalizations for children at low risk for severe febrile aplasia.
It is therefore necessary to identify other markers allowing the earliest possible classification of episodes of febrile aplasia.
A previous study, conducted by our team, PTX3 and febrile aplasia, studied pentraxin 3 (PTX3), a soluble PRR of the pentraxin family that plays a key role in immune surveillance against pathogens. Preliminary results obtained from samples from a cohort of patients treated in adult hematology and pediatric onco-hematology support a prognostic character of PTX3 in the severity of aplasia, with higher elevations of serum protein during episodes of severe sepsis or septic shock (ongoing analyses and interpretations for the adult population). The available data to date on the pediatric cohort are insufficient to conclude on the value of using PTX3. The investigators therefore wish to create a new paediatric cohort, in order to evaluate the PTX3 levels for the paediatric population and also to perform the assay of a new marker, clusterin.
Clusterin (CLU) is an extracellular chaperone protein of constitutive expression. The Innate Immunity team of the National Institute of Health and Medical Research (INSERM) "1307-Scientific Research National Center (CNRS) 6075" unit has shown that Clu binds to extracellular histones and inhibits their inflammatory, thrombotic and cytotoxic properties. The investigators also observed (i) that in adults without severe sepsis neutropenics, low serum levels of Clu at intake and lack of normalization of rates are associated with higher mortality and (ii) Clu levels are inversely correlated with circulating histone levels. All these data suggest that Clu would have a protective role for histone-induced lesions during sepsis independently of antibiotic treatment, opening an innovative therapeutic pathway in the management of severe sepsis.
CluPPFeN is based on the hypothesis that, in a pediatric population with episodes of febrile aplasia, serum Clu and serum PTX3 levels would discriminate between febrile episodes caused by bacterial infection and other etiologies and, As a result, would reduce the consumption of antibiotics, which provide resistance, and the length of hospitalization.
Read the detailed description
-Primary objective :
Evaluate serum levels CLU levels during febrile neutropenia in children followed for cancer.
-Secondary objective :
- Evaluate serum levels of CLU at the beginning of non-febrile aplasia and during a possible 2nd febrile peak
- Evaluate serum PTX3 levels during febrile neutropenia in children followed for cancer
- Explore the association between CLU, PTX3 and the severity of the aplasia episode
- Evaluate the association between CLU and PTX3 levels and the type of pathogen found during febrile aplasia
- Exploration of the diagnostic contribution of CLU and PTX3 in relation to other known parameters of inflammation (including C reactive protein (CRP), procalcitonin (PCT), fibrinogen, interleukin 1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-α), CXCL8, IL17)
- Exploration of genetic polymorphisms predisposing to bacterial and fungal infections (including PTX3 and CLU gene polymorphisms) in the context of febrile aplasia
- Conditions
- Cancer Childhood, Febrile Neutropenia
- Being tested
- Collection of blood sample
- Medical subject headings
- Neoplasms, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of blood sampleOther
- Visit 1 : At inclusion (day 1 of chemotherapy treatment)
- Visit 2 : Onset of aplasia
- Visit 3a : day 1 of the 1st febrile aplasia
- Visit 3b : day 3 of the 1st febrile episode
- Visit 3c : day 8 of the 1st febrile episode
- Visit 4a : second febrile episode (after 7 days)
- Visit 4b : day 3 of the second febrile episode (after 7 days)
| Study group | Role | What they receive |
|---|---|---|
| Cancer patient | Other | Collection of blood sample Receives: Other: Collection of blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate serum CLU levels during febrile neutropenia in children followed for cancer
Serum CLU levels will be estimated at day 1, day 3 and day 8 of febrile aplasia (PNN < 500/mm3). These assessments will also be performed at day 1 of the aplasing chemotherapy course (prior to chemotherapy administration, this value will be considered the reference value). The unit of analysis will be the number of CLU samples included in each scheduled visit.
Measured: At inclusion
Evaluate serum CLU levels during febrile neutropenia in children followed for cancer
Serum CLU levels will be estimated at day 1, day 3 and day 8 of febrile aplasia (PNN < 500/mm3). These assessments will also be performed at day 1 of the aplasing chemotherapy course (prior to chemotherapy administration, this value will be considered the reference value). The unit of analysis will be the number of CLU samples included in each scheduled visit.
Measured: up to 2 months
Secondary outcomes (2)
Evaluate serum levels of CLU at the beginning of non-febrile aplasia and during a possible 2nd febrile peak.
An estimate of CLU levels at the beginning of non-febrile aplasia (PNN < 500/mm3) as well as after a second episode of fever (2nd febrile peak) beyond day 7 will be made. An estimate of serum CLU levels will also be made at day 3 of the 2nd febrile peak
Measured: up to 2 months
Evaluate serum PTX3 levels during febrile neutropenia in children followed for cancer
Serum levels of PTX3 will be evaluated using the same pattern and assessment methods previously described for CLU.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start10 Oct 2022
- Primary completion13 Jun 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ChildhoodStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Coralie MALLEBRANCHE, Dr, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584930
- Sponsor's protocol ID
- 2022-A01750-43
- Acronym
- CluPPFeN
- Status last verified
- Dec 2024
- First submitted
- 10 Oct 2022
- Last updated
- 30 Dec 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 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Clusterin and Serum PTX3 Assay During Febrile Aplasia in Children Treated in Pediatric Oncology
- ClinicalTrials.gov ID
- NCT05584930
- Acronym / sponsor ID
- CluPPFeN / 2022-A01750-43
- Conditions
- Cancer Childhood, Febrile Neutropenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 18 Oct 2022 (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.
Febrile aplasia is a common occurrence in children/adults treated with chemotherapy for malignant blood diseases or solid cancers.
This acquired deficiency of immunity mainly causes susceptibility to bacterial and fungal infections, pathogens normally recognized by specific receptors of innate immunity (Pattern Recognition Receptor, PRR).
Thus, the febrile episodes in the context of post-chemotherapy neutropenia can be bacterial or fungal etiology, but can also frequently be related to viral infections, toxic phenomena or other etiologies. In the absence of a discriminating marker, treatment for all these children is based on early, broad-spectrum antibiotic therapy in hospital. Septic shock or even death by refractory septic shock remain, even if they are rare, real complications in pediatric oncology, requiring discriminatory markers for effective management, While trying to reduce the number and duration of hospitalizations for children at low risk for severe febrile aplasia.
It is therefore necessary to identify other markers allowing the earliest possible classification of episodes of febrile aplasia.
A previous study, conducted by our team, PTX3 and febrile aplasia, studied pentraxin 3 (PTX3), a soluble PRR of the pentraxin family that plays a key role in immune surveillance against pathogens. Preliminary results obtained from samples from a cohort of patients treated in adult hematology and pediatric onco-hematology support a prognostic character of PTX3 in the severity of aplasia, with higher elevations of serum protein during episodes of severe sepsis or septic shock (ongoing analyses and interpretations for the adult population). The available data to date on the pediatric cohort are insufficient to conclude on the value of using PTX3. The investigators therefore wish to create a new paediatric cohort, in order to evaluate the PTX3 levels for the paediatric population and also to perform the assay of a new marker, clusterin.
Clusterin (CLU) is an extracellular chaperone protein of constitutive expression. The Innate Immunity team of the National Institute of Health and Medical Research (INSERM) "1307-Scientific Research National Center (CNRS) 6075" unit has shown that Clu binds to extracellular histones and inhibits their inflammatory, thrombotic and cytotoxic properties. The investigators also observed (i) that in adults without severe sepsis neutropenics, low serum levels of Clu at intake and lack of normalization of rates are associated with higher mortality and (ii) Clu levels are inversely correlated with circulating histone levels. All these data suggest that Clu would have a protective role for histone-induced lesions during sepsis independently of antibiotic treatment, opening an innovative therapeutic pathway in the management of severe sepsis.
CluPPFeN is based on the hypothesis that, in a pediatric population with episodes of febrile aplasia, serum Clu and serum PTX3 levels would discriminate between febrile episodes caused by bacterial infection and other etiologies and, As a result, would reduce the consumption of antibiotics, which provide resistance, and the length of hospitalization.
Detailed description
-Primary objective :
Evaluate serum levels CLU levels during febrile neutropenia in children followed for cancer.
-Secondary objective :
- Evaluate serum levels of CLU at the beginning of non-febrile aplasia and during a possible 2nd febrile peak
- Evaluate serum PTX3 levels during febrile neutropenia in children followed for cancer
- Explore the association between CLU, PTX3 and the severity of the aplasia episode
- Evaluate the association between CLU and PTX3 levels and the type of pathogen found during febrile aplasia
- Exploration of the diagnostic contribution of CLU and PTX3 in relation to other known parameters of inflammation (including C reactive protein (CRP), procalcitonin (PCT), fibrinogen, interleukin 1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-α), CXCL8, IL17)
- Exploration of genetic polymorphisms predisposing to bacterial and fungal infections (including PTX3 and CLU gene polymorphisms) in the context of febrile aplasia
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patient | Other | Other: Collection of blood sampleCollection of blood sample |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Child under 18 years
- Hospitalized for chemotherapy leading to febrile aplasia
- Signature of the informed consent of the parents or holder of parental authority and consent of the patient
Key exclusion criteria (2 listed)
- Expected non aplasing chemotherapy
- Child with less than 5 kg body weight at inclusion
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 |
|---|---|---|
| Collection of blood sample* Visit 1 : At inclusion (day 1 of chemotherapy treatment) * Visit 2 : Onset of aplasia * Visit 3a : day 1 of the 1st febrile aplasia * Visit 3b : day 3 of the 1st febrile episode * Visit 3c : day 8 of the 1st febrile episode * Visit 4a : second febrile episode (after 7 days) * Visit 4b : day 3 of the second febrile episode (after 7 days) | Other | Cancer patient |
Primary outcome
Evaluate serum CLU levels during febrile neutropenia in children followed for cancer
Time frame: At inclusion
Serum CLU levels will be estimated at day 1, day 3 and day 8 of febrile aplasia (PNN < 500/mm3). These assessments will also be performed at day 1 of the aplasing chemotherapy course (prior to chemotherapy administration, this value will be considered the reference value). The unit of analysis will be the number of CLU samples included in each scheduled visit.
Evaluate serum CLU levels during febrile neutropenia in children followed for cancer
Time frame: up to 2 months
Serum CLU levels will be estimated at day 1, day 3 and day 8 of febrile aplasia (PNN < 500/mm3). These assessments will also be performed at day 1 of the aplasing chemotherapy course (prior to chemotherapy administration, this value will be considered the reference value). The unit of analysis will be the number of CLU samples included in each scheduled visit.
2 secondary outcomes
Evaluate serum levels of CLU at the beginning of non-febrile aplasia and during a possible 2nd febrile peak.
Time frame: up to 2 months
Evaluate serum PTX3 levels during febrile neutropenia in children followed for cancer
Time frame: up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 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. This study is not recruiting at the moment.
Coralie MALLEBRANCHE, Dr principal investigator
UH Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of blood sample in people with Cancer Childhood and Febrile Neutropenia, run by University Hospital, Angers 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 30 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate serum CLU levels during febrile neutropenia in children followed for cancer (time frame: At inclusion). The study lists 2 primary outcomes in all. 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 30 Dec 2024.