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Not yet recruitingNCT06658587Updated Oct 26, 2024

A Novel Serological Risk Model for Early Non-invasive Diagnosis of Cholangiocarcinoma

An observational study in Cholangiocarcinoma, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-26.

Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 75 Years
Sex
All
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Study summary

This is a prospective, observational and exploratory clinical study. The object of this study is to evaluate the accuracy of a novel serological risk model on blood samples in early diagnosis of cholangiocarcinoma patients.

Read the detailed description

A reliable and accurate preoperative tool capable of early diagnosing malignant cholangiocarcinoma is lacking and urgently needed for clinical practice. This study proposes to establish and evaluate a novel serological risk model on blood samples for non-invasively diagnosing cholangiocarcinoma. The study includes the construction of capable novel serological risk model and the validation of the diagnosis model.

02

Conditions studied

  • Cholangiocarcinoma

Keywords

  • Hilar Cholangiocarcinoma
  • Intrahepatic Cholangiocarcinoma
  • Extrahepatic Cholangiocarcinoma
  • Early Diagnosis
  • Non-invasive Diagnosis
  • Serological
  • Prognosis
  • Chemotherapeutic Benefits
03

In context

Cholangiocarcinoma

930 studies on the registry are indexed under Cholangiocarcinoma; 292 are open to participants now.

This study's planned enrollment of 60 is below the median of 176 across 180 observational studies indexed under Cholangiocarcinoma.

Browse Cholangiocarcinoma studies →

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 477 studies on the registry; 278 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients who had suspected cholangiocarcinoma and completed the blood collection before surgery

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

  • 1. The patient must sign an informed consent form;
  • 2. Age 18-75 years old, both male and female;
  • 3. ECOG performance status score (PS score) 0-2;
  • 4. Cholangiocarcinoma with resectable tumor lesions;
  • 5. Complete the blood collection before treatment;

Exclusion criteria

Exclusion Criteria:

  • 1. Accompanied with other primary malignant tumors;
  • 2. Patients who have neoadjuvant chemotherapy or other tumor-targeted therapies;
  • 3. Incomplete serological examinations or medical history data.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Sun Yat-Sen Memorial Hospital of Sun Yat-sen University

    The cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is the exploration cohort.

    Diagnostic Test: No interventions

Interventions

  • Diagnostic testNo interventions

    No interventions

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What researchers measure

Primary outcomes

  1. Malignant/Benign status of enrolled suspected cholangiocarcinoma patients by pathological examination

    The pathological examination results of each enrolled patient will be recorded

    Time frame: 4 weeks

  2. Malignant/Benign status of enrolled suspected cholangiocarcinoma patients evaluated by the novel serological risk model

    The novel serological risk model will be constructed for differential malignant/benign diagnosis

    Time frame: 2 weeks

07

Study locations

1 site
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510220, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06658587
Responsible party
Sponsor
First posted
Oct 26, 2024
Start date
Nov 1, 2024 (estimated)
Primary completion
Oct 30, 2026 (estimated)
Completion
Oct 30, 2027 (estimated)
Last update
Oct 26, 2024

Study contacts

Honghua Zhang, PhD
Contact
zhanghh68@mail.sysu.edu.cn
020-34078840
Chao Liu, PhD
Contact
liuchao3@mail.sysu.edu.cn
+86 18922182850
Chao Liu, PhD
principal investigator · Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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