ClinicalTrials.gg
Not yet recruitingNCT07788131Updated Aug 26, 2026

Inflammatory Biomarkers and Disease Activity in Inflammatory Bowel Disease

An observational study in Inflammatory Bowel Diseases, Crohn Disease and Ulcerative Colitis (UC), sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 45 studies in Inflammatory Bowel Diseases by Assiut University — 20 open to participants now, 20 under way, none of them phase 3. Inflammatory Bowel Diseases · Assiut University.

Planned enrollment
8th of 41
120 · median 100
Started
2026
with 11 others
Observational
41 of 45
19 open now
Primary completion
2027-09
later than 11 of 19 live
Registered
39th of 45
by date

Among the 45 studies in Inflammatory Bowel Diseases by Assiut University, this one is the 8th largest by planned enrollment of the 41 observational ones that give a count, is one of 12 that started in 2026, is one of 41 observational ones, reaches primary completion later than 11 of the 19 other live ones, and was the 39th registered.

Inflammatory Bowel Diseases

1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 425 are open to participants now.

Browse Inflammatory Bowel Diseases studies →

Open to participants now

20 of the 45 studies in Inflammatory Bowel Diseases by Assiut University are open now, in 1 country. Recruiting first, the newest first:

14 more — sign in →

By country, each count listing its studies:

All 20 open studies →

Where they have run

Who these studies take

Of the 277 Inflammatory Bowel Diseases studies recruiting now, 133 (48%) set no upper age limit and 117 (42%) stop at 75 or younger; 76 take children under 18; 61 take healthy volunteers.

This study: 18 Years and older · all sexes.

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02

Study summary

This study aims to evaluate the diagnostic accuracy and clinical utility of routine blood-derived inflammatory biomarker ratios in assessing disease activity among adult patients with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis.

Endoscopy is the standard method for evaluating mucosal inflammation in IBD, but it is invasive, costly, and inconvenient for frequent disease monitoring. Non-invasive, inexpensive laboratory markers derived from standard routine blood tests, specifically the C-reactive protein-to-albumin ratio (CAR), platelet-to-albumin ratio (PAR), neutrophil-to-lymphocyte ratio (NLR), fibrinogen-to-albumin ratio (FAR), and hemoglobin-to-CRP ratio (Hb/CRP), have shown potential in reflecting systemic and intestinal inflammation.

Participants enrolled in this cross-sectional study will undergo routine clinical disease activity evaluations and standard blood tests. For patients undergoing routine colonoscopy, endoscopic disease activity scores will also be recorded. The primary goal is to determine how accurately these blood-based ratios can differentiate active IBD from disease remission, providing a simple, cost-effective tool for regular patient monitoring.

Read the detailed description

Inflammatory bowel disease (IBD), encompassing Crohn's disease and ulcerative colitis, is a chronic relapsing condition requiring regular evaluation of disease activity to guide clinical decision-making and therapeutic management. While endoscopic assessment is the gold standard for mucosal evaluation, its routine application is limited by invasiveness, procedure risks, and high healthcare costs.

This cross-sectional study investigates the diagnostic accuracy and clinical utility of non-invasive, blood-based inflammatory ratios: C-reactive protein-to-albumin ratio (CAR), platelet-to-albumin ratio (PAR), neutrophil-to-lymphocyte ratio (NLR), fibrinogen-to-albumin ratio (FAR), and hemoglobin-to-C-reactive protein ratio (Hb/CRP).

Participants are recruited from the Clinical Pathology and Gastroenterology and Hepatology departments at Assiut University Hospital. Clinical disease activity is assessed using standardized clinical scores: the Mayo Clinic Score or Partial Mayo Score for ulcerative colitis, and the Crohn's Disease Activity Index (CDAI) or Harvey-Bradshaw Index (HBI) for Crohn's disease. In participants with available routine colonoscopy data within the study window, endoscopic disease activity is recorded using the Mayo Endoscopic Score (MES) or Ulcerative Colitis Endoscopic Index of Severity (UCEIS) for ulcerative colitis, and the Simple Endoscopic Score for Crohn's Disease (SES-CD) for Crohn's disease.

Venous blood samples are analyzed for complete blood count (CBC), serum albumin, C-reactive protein (CRP), and fibrinogen using automated laboratory analyzers (Advia and Atellica platforms) to calculate the corresponding inflammatory ratios and assess their discriminatory capacity.

03

Conditions studied

  • Inflammatory Bowel Diseases
  • Crohn Disease
  • Ulcerative Colitis (UC)

Keywords

  • C-reactive protein-to-albumin ratio
  • Platelet-to-albumin ratio
  • Neutrophil-to-lymphocyte ratio
  • Fibrinogen-to-albumin ratio
  • Hemoglobin-to-CRP ratio
  • Disease Activity
  • Endoscopy
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Adult patients with an established diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis) presenting to the Department of Gastroenterology and Hepatology and the Department of Clinical Pathology at Assiut University Hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 years or older
  • Established diagnosis of Crohn's disease or ulcerative colitis
  • Availability of adequate clinical information for disease activity assessment
  • For the endoscopic subgroup: colonoscopy performed as part of routine clinical care within the study window with an available endoscopic report and corresponding disease activity score

Exclusion criteria

Exclusion Criteria:

  • Acute systemic infection at the time of assessment
  • Active
  • Other active systemic inflammatory or diseases likely to significantly influence inflammatory biomarkers
  • Significant hematological disease affecting , leukocyte, neutrophil, lymphocyte, or counts
  • Severe renal or hepatic dysfunction likely to substantially influence albumin or inflammatory markers
  • Recent major surgery
  • Pregnancy
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • IBD Patients

    Adult patients aged 18 years or older with an established diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis) undergoing clinical and/or endoscopic disease activity evaluation along with routine laboratory investigations.

06

What researchers measure

Primary outcomes

  1. Area Under the Receiver Operating Characteristic Curve (AUC) of the C-Reactive Protein-to-Albumin Ratio (CAR)

    AUC will be calculated using receiver operating characteristic (ROC) analysis to determine the diagnostic accuracy of the C-reactive protein-to-albumin ratio (CAR) in discriminating active disease from remission in patients with inflammatory bowel disease, defined by clinical disease activity scores (Mayo Clinic Score/Partial Mayo Score for ulcerative colitis and CDAI/HBI for Crohn's disease). Values range from 0.5 (no discrimination) to 1.0 (perfect discrimination).

    Time frame: Day 1

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2026
First posted
Aug 26, 2026
StartEst.
Sep 2026
Primary completionEst.
Sep 2027
CompletionEst.
Oct 2027
Last update
Aug 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07788131
Lead sponsor
Assiut University
Responsible party
Amera Ali Mohamed Yousef (Resident of Clinical Pathology, Assiut University) — Principal investigator
First posted
Aug 26, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Aug 26, 2026
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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