NCT07236333

Brief Summary

The aim of this study is to demonstrate the type and amount of retention in the colon during ulcerative colitis activation, as well as the relationship between C-reactive protein (CRP), albumin and the calculated CALLY index. The investigators also aim to establish whether this ratio can be used to indicate activation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

4.6 years

First QC Date

September 24, 2025

Last Update Submit

November 14, 2025

Conditions

Ulcerative Colitis (UC)

Keywords

Ulcerative ColitisCALLYHAALP

Outcome Measures

Primary Outcomes (2)

  • Change in Patients' HALP Score

    Ulcerative colitis patients will be evaluated by evaluating the Change in HALP Score and its effect on prognosis.

    through study completion, an average of 1 year

  • Change in Patients' CALLY Index Score

    Ulcerative colitis patients will be evaluated by evaluating the Change in CALLY Index Score and its effect on prognosis.

    through study completion, an average of 1 year

Interventions

CALLYDIAGNOSTIC_TEST

The CALLY index, integrating C-reactive protein (CRP), albumin, and lymphocyte count, has been identified as a promising prognostic biomarker.

HALPDIAGNOSTIC_TEST

The HALP score is calculated as HALP Score = \[hemoglobin (g/L) × albumin (g/L) × lymphocytes (/L)\]/platelets (/L). It is a definitive biomarker.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Ulserative colitis patients

You may qualify if:

  • under 18

You may not qualify if:

  • no UC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Antalya, 07030, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 24, 2025

First Posted

November 19, 2025

Study Start

June 1, 2020

Primary Completion

December 31, 2024

Study Completion

March 31, 2025

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations

TU(1)