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Ulcerative Colitis (UC)DETECT-UCANNCT07742410

The Fecal Immunoassay Occult Blood Test Combined With Calprotectin Sequential Linkage Imaging Endoscopy Screening Strategy for Monitoring Tumor Changes Associated With Long-duration Ulcerative Colitis

An observational study of Ulcerative Colitis (UC), run by Qilu Hospital of Shandong University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Ulcerative colitis (UC) is a chronic inflammatory bowel disease associated with an increased risk of colorectal cancer, known as UC-associated neoplasia (UCAN). Current guidelines recommend regular colonoscopy surveillance for long-standing UC patients, but this strategy faces challenges including poor adherence and… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis (UC)
How many people
250 participants
Where
No sites listed yet
Study dates
23 Jul 2026to 31 Dec 2029
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with long-standing ulcerative colitis at high risk for UCAN, including those with disease duration >10 years (E1/E2) or >8 years (E3), those with primary sclerosing cholangitis (PSC), those with a first-degree family history of colorectal cancer, or those with a history of colorectal neoplasia resected.

Who may be able to join

  • Age 18-75 years, any gender.
  • Definite diagnosis of ulcerative colitis by clinical, endoscopic, and pathological criteria.
  • Meeting at least one of the following high-risk criteria (with first onset of mucopurulent bloody stool as the starting time): E1/E2 disease duration >10 years; E3 disease duration >8 years; with primary sclerosing cholangitis (PSC); first-degree family history of colorectal cancer; history of colorectal neoplasia resected.
  • Discontinued any form of glucocorticoids for at least 4 weeks prior to enrollment.
  • In clinical remission at enrollment (stool frequency score <3, rectal bleeding score = 0).
  • Able to understand the study, voluntarily participate, and sign written informed consent.

Who cannot join

  • Presence of other gastrointestinal diseases or tumors.
  • Severe comorbidities (e.g., cardiopulmonary insufficiency, hepatic or renal failure) that may affect study results or preclude tolerance of endoscopy.
  • Currently taking antiplatelet or anticoagulant medications (aspirin, warfarin, rivaroxaban, etc.).
  • Pregnant or breastfeeding women.
  • History of total or subtotal colectomy.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

yan zhang contact

8618769783511

yuyanbo2000@126.com

About this study

Official title: Diagnostic Performance of Fecal Immunochemical Test Combined With Fecal Calprotectin Sequential Linked Color Imaging Endoscopy for Surveillance of Colitis-Associated Neoplasia in Long-standing Ulcerative Colitis: A Multicenter, Prospective Cohort Study

Ulcerative colitis (UC) is a chronic inflammatory bowel disease associated with an increased risk of colorectal cancer, known as UC-associated neoplasia (UCAN). Current guidelines recommend regular colonoscopy surveillance for long-standing UC patients, but this strategy faces challenges including poor adherence and low neoplasia detection rates. This study aims to evaluate the diagnostic performance of a non-invasive pre-screening strategy combining fecal immunochemical test (FIT) and fecal calprotectin (FC), followed by linked color imaging (LCI) colonoscopy, for detecting UCAN in patients with long-standing UC.

This is a multicenter, prospective, diagnostic cohort study. Eligible patients with long-standing UC (disease duration >8 years for extensive colitis or >10 years for left-sided colitis, or with PSC) will undergo FIT and FC testing, followed by LCI colonoscopy within 4 weeks regardless of stool test results. The primary outcome is the diagnostic performance (sensitivity, specificity, PPV, NPV) of combined FIT+FC testing for UCAN, using LCI colonoscopy with histopathology as the reference standard. A total of 250 participants will be enrolled from 6 centers in China. Secondary outcomes include UCAN detection rate, feasibility indicators, patient adherence and acceptability, optimal cut-off values for FIT and FC, and 12-month miss rate.

Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07742410
Study groupRoleWhat they receive
Long-standing Ulcerative Colitis High-risk CohortParticipants with long-standing UC meeting high-risk criteria (disease duration >8/10 years, PSC, family history, or prior neoplasia). All participants undergo a unified surveillance protocol: baseline data collection → fecal sample collection for FIT and FC testing → LCI colonoscopy within 4 weeks regardless of stool test results.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic Performance of Combined FIT+FC for UCAN

    Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-) of combined FIT+FC testing (either positive defined as positive) for detecting UCAN, using LCI colonoscopy with histopathology as the reference standard.

    Measured: At time of colonoscopy (within 4 weeks after stool sample collection)

Secondary outcomes (6)

  1. UCAN Detection Rate

    Proportion of patients with pathologically confirmed UCAN (LGD, HGD, or CRC) among all patients who complete LCI colonoscopy

    Measured: At time of colonoscopy

  2. Comprehensive completion rate of the joint screening process

    Unit of measurement: Percentage (%) Detailed description

    To evaluate the overall implementation quality of the "FIT+FC sequential LCI" screening strategy, this indicator was set as a composite endpoint. Summary rule (mathematical definition) : Subjects who simultaneously meet all of the following five conditions are defined as "fully compliant process participants" :

    • Fecal sample collection was successful;
    • The sample quality is qualified;
    • Both the FIT and FC laboratory tests have been completed. ④ Complete the LCI colonoscopy within 4 weeks; ⑤ The Boston Quality of Bowel Preparation Scale (BBPS) score is ≥ 6 points. The reported value of this result measurement item = (the number of fully compliant process participants/the total number of participants in the group) × 100%. (Note: The completion rates of each individual link will be presented as baseline characteristics or descriptive data in the attached materials, and will not be separately used as result measurement items for

    Measured: Week 4 LCI colonoscopy

  3. Patient Adherence

    Proportion of patients completing colonoscopy within the 4-week time window

    Measured: Within 4 weeks after stool collection

  4. Patient Acceptability

    Patient acceptance scores for stool testing and colonoscopy, discomfort scores, willingness to repeat, assessed by standardized questionnaire.

    1. Fecal Test Acceptability Questionnaire, score range: 6 to 30 points. The meaning of the score: A higher score = better results (higher acceptance).
    2. Colonoscopy Experience Scale Score range: • Acceptance dimension (Items 1-3) : 3-15 points
    • Comfort/Discomfort dimension (Items 4-6) : 3-15 points (Note direction) Overall experience dimension (Items 7-9) : 3-15 points
    • Total score: 9-45 points Score meaning: A higher score = a better outcome (higher acceptance, less discomfort, and a better overall experience)
    1. Willingness for Repeat Examination Score range: 4 to 20 points Score meaning: A higher score = a better outcome (stronger willingness to accept again)

    Measured: At 4-week follow-up

  5. Optimal Cut-off Values

    Optimal cut-off values for FIT and FC alone and in combination for predicting UCAN, determined by ROC curve analysis

    Measured: Week 52

  6. 12-Month Miss Rate

    Proportion of new UCAN cases detected during 12-month follow-up among patients with negative baseline colonoscopy

    Measured: 12 months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2026
  2. Study start23 Jul 2026 (estimated)
  3. Primary completion31 Aug 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

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
250 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07742410
Sponsor's protocol ID
DETECT-UCAN-2026-07
Acronym
DETECT-UCAN
Status last verified
Jul 2026
First submitted
24 Jul 2026
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis (UC), run by Qilu Hospital of Shandong University.

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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact yan zhang (8618769783511, yuyanbo2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic Performance of Combined FIT+FC for UCAN (time frame: At time of colonoscopy (within 4 weeks after stool sample collection)). 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 NCT07742410.

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 3 Aug 2026.

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