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NCT Number: NCT06658587

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510220, China

Location contact

Honghua Zhang, PhD

CONTACT

[email protected]

020-34078840

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

No Interventions

Diagnostic Test

No interventions

Primary outcomes

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

    Time frame: 4 weeks

    The pathological examination results of each enrolled patient will be recorded

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

    Time frame: 2 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Liu, PhD

CONTACT

[email protected]

+86 18922182850

Honghua Zhang, PhD

CONTACT

[email protected]

020-34078840

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Clinical Study on the Accuracy of Novel Serological Risk Model in Early Diagnosis of Cholangiocarcinoma Patients

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 26, 2024
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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