Neutropenic EnterocolitisPROFANENCT04438278
Profile Fecal Analysis of Neutropenic Enterocolitis
An observational study of Neutropenic Enterocolitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
A prospective, single-center, cohort study to allow collecting observations of patients receiving induction chemotherapy for primary Acute Myeloid Leukemia (AML), collecting biological samples(including fecal samples for microbiota analyses, and metagenomic profiling in blood samples) and clinical outcomes (notably… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neutropenic Enterocolitis
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2020to Jul 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients receiving induction chemotherapy for primary Acute Myeloid Leukemia (AML)
Who may be able to join
- patient>= 18 years old;
- cytological diagnosis of de novo Acute Myeloid Leukemia (AML) (>20% myeloid blasts);
- eligible for intensive chemotherapy (no severe co-morbidity);
- not having received any prior chemotherapy;
- affiliation to the national social security system.
Who cannot join
- acute promyelocytic leukemia (AML 3);
- inability to understand the nature of investigations or to give informed non-opposition;
- person subject to a legal protection measure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neutropenic Enterocolitis in Critically Ill Hematological Patients: Taxonomic and Functional Analysis of Gut Microbiota
A prospective, single-center, cohort study to allow collecting observations of patients receiving induction chemotherapy for primary Acute Myeloid Leukemia (AML), collecting biological samples(including fecal samples for microbiota analyses, and metagenomic profiling in blood samples) and clinical outcomes (notably the occurrence of neutropenic enterocolitis), with a nested case-control analysis comparing patients with or without neutropenic enterocolitis
- Conditions
- Neutropenic Enterocolitis
- Medical subject headings
- Enterocolitis, Neutropenic
What is being measured
The primary outcome is the main question the study is designed to answer.
Shannon index of α-diversity
Shannon index of α-diversity assessed by shotgun metagenomic analysis of the stool
Measured: At day 1, before chemotherapy initiation
Secondary outcomes (9)
Fecal microbiota's profile
Taxonomic identification in shotgun metagenomic
Measured: At day 14
Intensive Care Unit (ICU) - mortality
Death while hospitalized in the intensive care unit
Measured: 60 days
Hospital - mortality
Death while hospitalized
Measured: 60 days
1-year mortality
Death within 1 year of inclusion
Measured: 1 year
Occurrence of any local neutropenic enterocolitis complications
Local neutropenic enterocolitis complications defined as perforation or digestive hemorrhage or abscess
Measured: 60 days
Occurrence of microbiologically documented infections in patients with severe neutropenic enterocolitis
Microbiologically documented infections defined as pneumonia, invasive device infections, urinary tract infections, digestive or neuro-meningitis infections
Measured: 60 days
Occurrence of malnutrition in patients with severe neutropenic enterocolitis
Malnutrition defined by the European Society of Clinical nutrition and Metabolism
Measured: 60 days
Biodiversity in microbiota
Analysis of alpha and beta-diversity in fecal samples from day 0 to day 60
Measured: Day 1, day 14, day 28, day 42
Whole-blood metatranscriptomic profile evolution
Identification of clusters of gene expression
Measured: Day 1, day 14, day 28, day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start8 Jul 2020
- Primary completion8 Jul 2022 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neutropenic EnterocolitisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 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
- NCT04438278
- Sponsor's protocol ID
- APHP190826
- Acronym
- PROFANE
- Status last verified
- Jun 2021
- First submitted
- 26 May 2020
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kapandji N, Salmona M, Lemoine A, Ulmann G, Calderaro J, Roche B, Kapel N, Biard L, Lengline E, Goff JL, Rodriguez C, Thomas M, Zafrani L. Unravelling neutropenic enterocolitis: insights from gut microbiota, and intestinal barrier analyses. Exp Hematol Oncol. 2025 May 16;14(1):74. doi: 10.1186/s40164-025-00661-4.
PubMed 40380332
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutropenic Enterocolitis in Critically Ill Hematological Patients: Taxonomic and Functional Analysis of Gut Microbiota
- ClinicalTrials.gov ID
- NCT04438278
- Acronym / sponsor ID
- PROFANE / APHP190826
- Conditions
- Neutropenic Enterocolitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 8 Jul 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 18 Jun 2020 (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.
A prospective, single-center, cohort study to allow collecting observations of patients receiving induction chemotherapy for primary Acute Myeloid Leukemia (AML), collecting biological samples(including fecal samples for microbiota analyses, and metagenomic profiling in blood samples) and clinical outcomes (notably the occurrence of neutropenic enterocolitis), with a nested case-control analysis comparing patients with or without neutropenic enterocolitis
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients receiving induction chemotherapy for primary Acute Myeloid Leukemia (AML)
Key inclusion criteria (5 listed)
- patient>= 18 years old;
- cytological diagnosis of de novo Acute Myeloid Leukemia (AML) (>20% myeloid blasts);
- eligible for intensive chemotherapy (no severe co-morbidity);
- not having received any prior chemotherapy;
- affiliation to the national social security system.
Key exclusion criteria (3 listed)
- acute promyelocytic leukemia (AML 3);
- inability to understand the nature of investigations or to give informed non-opposition;
- person subject to a legal protection measure.
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
Shannon index of α-diversity
Time frame: At day 1, before chemotherapy initiation
Shannon index of α-diversity assessed by shotgun metagenomic analysis of the stool
9 secondary outcomes
Fecal microbiota's profile
Time frame: At day 14
Intensive Care Unit (ICU) - mortality
Time frame: 60 days
Hospital - mortality
Time frame: 60 days
1-year mortality
Time frame: 1 year
Occurrence of any local neutropenic enterocolitis complications
Time frame: 60 days
Occurrence of microbiologically documented infections in patients with severe neutropenic enterocolitis
Time frame: 60 days
Occurrence of malnutrition in patients with severe neutropenic enterocolitis
Time frame: 60 days
Biodiversity in microbiota
Time frame: Day 1, day 14, day 28, day 42
Whole-blood metatranscriptomic profile evolution
Time frame: Day 1, day 14, day 28, day 42
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Derived from this study: PubMed 40380332Kapandji N, Salmona M, Lemoine A, Ulmann G, Calderaro J, Roche B, Kapel N, Biard L, Lengline E, Goff JL, Rodriguez C, Thomas M, Zafrani L. Unravelling neutropenic enterocolitis: insights from gut microbiota, and intestinal barrier analyses. Exp Hematol Oncol. 2025 May 16;14(1):74. doi: 10.1186/s40164-025-00661-4.
- Individual participant dataSharing planned: No
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.
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 Neutropenic Enterocolitis, 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 5 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: status not confirmed, as of the sponsor's last update on 22 Jun 2021. 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 Lara Zafrani, MD PhD (+33 1 42 49 49 49, lara.zafrani@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shannon index of α-diversity (time frame: At day 1, before chemotherapy initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04438278, which also lists 1 linked publication.
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 22 Jun 2021.