Acute Abdominal PainBIOMABNCT02399150
Biomarkers in Acute Abdomen
An observational study of Acute Abdominal Pain, run by Pitié-Salpêtrière Hospital at 1 site in France.
Trial summary
Background: In the emergency setting, acute abdominal pain is a diagnostic challenge, as pain is a subjective measure, and serious causes needing surgical intervention do not always meet the clinical picture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Abdominal Pain
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Sep 2016
- 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: patients presenting to the ED with acute abdomen
Who may be able to join
- Presentation at ED with acute abdominal pain, aged at least 18 years
Who cannot join
- No informed consent, pregnancy, homeless, no social assurance
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Accueil des Urgences, CHU Pitié-Salpêtrière
Paris, 75013
About this study
Official title: Biomarkers in Acute Abdomen (BIOMAB)
Background: In the emergency setting, acute abdominal pain is a diagnostic challenge, as pain is a subjective measure, and serious causes needing surgical intervention do not always meet the clinical picture. Biomarkers measuring the individual stress or pain level may aid in identifying surgical emergencies, but there are many influencing factors that have to be taken into account.
Objective: To evaluate defined stress biomarkers for their diagnostic and prognostic utility in measuring pain, and to evaluate potential influencing or confounding factors.
Read more
Design: Prospective observational study in 200 patients presenting to the emergency department with acute abdominal pain.
Estimated duration: May 2015 - May 2016 Location Setting: Emergency Department (ED) of the Hôpital Universitaire Pitié-Salpétrière, Paris, France.
Study population: 200 patients presenting to the ED with acute abdomen
Eligibility criteria:
- Inclusion criteria: Presentation at ED with acute abdominal pain, aged at least 18 years
- Exclusion criteria: no informed consent, pregnancy, homeless, no social assurance
Procedure:
Patients presenting to the ED with acute abdominal pain will be included after informed consent is given. Blood and saliva samples will be drawn initially and after 4 hours, and baseline data assessed. All diagnostic procedures results and diagnosis made by the treating physicians as well as initiated treatment will be recorded Final diagnosis and outcome will be assessed by 2-week-telephone interview.
Measurement of candidate biomarkers will be performed in collected material. Copeptin and SAA will be measured as potential biomarkers, as a control value, cortisol will be obtained. Other biomarkers will be in consideration, depending upon availability and financial aspects.
Safety evaluations: All recommendations outlined in the ICH Guidelines for Good Clinical Practice will be adhered to throughout this trial.
Sample size considerations: The number of patients of this pilote study is based on the estimate of 25 % or 50 of acute abdomen patients to have a surgical emergency.
Significance of the study: If a biomarker is found that safely discriminates between surgical urgency and harmless abdominal pain, this will spare radiologic exposure in often young patients and will aid in optimized allocation of health care resources.
- Conditions
- Acute Abdominal Pain
- Being tested
- No intervention as observational study
- Keywords
- acute abdomen, Pain, stress biomarker
- Medical subject headings
- Abdomen, Acute, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention as observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| Acute Abdominal Pain | patients presenting to the ED with acute abdomen Receives: Other: No intervention as observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic value of biomarkers for discriminating between self-limiting abdominal pain and acute surgical emergency
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2016
- Study completionSep 2016
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 Acute Abdominal PainStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pitié-Salpêtrière Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation
- Responsible party
- Principal investigator, Hausfater Pierre, Groupe Hospitalier Pitie-Salpetriere
- Investigators
- Pierre Hausfater, MD, Pr, Principal investigator, Service d'Accueil des Urgences, CHU Pitié-Salpêtrière, AP-HP et Université Pierre et Marie Curie Paris 06, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399150
- Sponsor's protocol ID
- BIOMAB
- Acronym
- BIOMAB
- Status last verified
- May 2017
- First submitted
- 23 Mar 2015
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Blum CA, Faron M, Paquet AL, Velly L, Brochet C, Tresallet C, Hausfater P. Biomarkers for Detecting Surgical Emergency in Acute Abdomen-A Prospective Observational Study. J Appl Lab Med. 2025 Nov 4;10(6):1537-1551. doi: 10.1093/jalm/jfaf137.
PubMed 41189107
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Acute Abdomen (BIOMAB)
- ClinicalTrials.gov ID
- NCT02399150
- Acronym / sponsor ID
- BIOMAB / BIOMAB
- Conditions
- Acute Abdominal Pain
- Keywords
- acute abdomen, Pain, stress biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Pitié-Salpêtrière HospitalUniversity, hospital or other
- Collaborators
- Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation
- Study start
- May 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 26 Mar 2015 (estimated)
- 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.
Background: In the emergency setting, acute abdominal pain is a diagnostic challenge, as pain is a subjective measure, and serious causes needing surgical intervention do not always meet the clinical picture. Biomarkers measuring the individual stress or pain level may aid in identifying surgical emergencies, but there are many influencing factors that have to be taken into account.
Objective: To evaluate defined stress biomarkers for their diagnostic and prognostic utility in measuring pain, and to evaluate potential influencing or confounding factors.
Design: Prospective observational study in 200 patients presenting to the emergency department with acute abdominal pain.
Estimated duration: May 2015 - May 2016 Location Setting: Emergency Department (ED) of the Hôpital Universitaire Pitié-Salpétrière, Paris, France.
Study population: 200 patients presenting to the ED with acute abdomen
Eligibility criteria:
- Inclusion criteria: Presentation at ED with acute abdominal pain, aged at least 18 years
- Exclusion criteria: no informed consent, pregnancy, homeless, no social assurance
Procedure:
Patients presenting to the ED with acute abdominal pain will be included after informed consent is given. Blood and saliva samples will be drawn initially and after 4 hours, and baseline data assessed. All diagnostic procedures results and diagnosis made by the treating physicians as well as initiated treatment will be recorded Final diagnosis and outcome will be assessed by 2-week-telephone interview.
Measurement of candidate biomarkers will be performed in collected material. Copeptin and SAA will be measured as potential biomarkers, as a control value, cortisol will be obtained. Other biomarkers will be in consideration, depending upon availability and financial aspects.
Safety evaluations: All recommendations outlined in the ICH Guidelines for Good Clinical Practice will be adhered to throughout this trial.
Sample size considerations: The number of patients of this pilote study is based on the estimate of 25 % or 50 of acute abdomen patients to have a surgical emergency.
Significance of the study: If a biomarker is found that safely discriminates between surgical urgency and harmless abdominal pain, this will spare radiologic exposure in often young patients and will aid in optimized allocation of health care resources.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Abdominal Pain | – | Other: No intervention as observational studypatients presenting to the ED with acute abdomen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients presenting to the ED with acute abdomen
Key inclusion criteria (1 listed)
- Presentation at ED with acute abdominal pain, aged at least 18 years
Key exclusion criteria (1 listed)
- No informed consent, pregnancy, homeless, no social assurance
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 |
|---|---|---|
| No intervention as observational study | Other | Acute Abdominal Pain |
Primary outcome
diagnostic value of biomarkers for discriminating between self-limiting abdominal pain and acute surgical emergency
Time frame: 15 days
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 9 May 2017.
- Derived from this study: PubMed 41189107Blum CA, Faron M, Paquet AL, Velly L, Brochet C, Tresallet C, Hausfater P. Biomarkers for Detecting Surgical Emergency in Acute Abdomen-A Prospective Observational Study. J Appl Lab Med. 2025 Nov 4;10(6):1537-1551. doi: 10.1093/jalm/jfaf137.
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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.
Pierre Hausfater, MD, Pr principal investigator
Service d'Accueil des Urgences, CHU Pitié-Salpêtrière, AP-HP et Université Pierre et Marie Curie Paris 06, Paris
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 Acute Abdominal Pain, run by Pitié-Salpêtrière Hospital 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 1 inclusion and 1 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 9 May 2017. 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?
diagnostic value of biomarkers for discriminating between self-limiting abdominal pain and acute surgical emergency (time frame: 15 days). 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 NCT02399150, 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 9 May 2017.