CholangiocarcinomaNCT06658587
A Novel Serological Risk Model for Early Non-invasive Diagnosis of Cholangiocarcinoma
An observational study of Cholangiocarcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholangiocarcinoma
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 30 Oct 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who had suspected cholangiocarcinoma and completed the blood collection before surgery
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510220
Honghua Zhang, PhD, 020-34078840, zhanghh68@mail.sysu.edu.cn
About this study
Official title: Clinical Study on the Accuracy of Novel Serological Risk Model in Early Diagnosis of Cholangiocarcinoma Patients
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.
- Conditions
- Cholangiocarcinoma
- Being tested
- No interventions
- Keywords
- Hilar Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, Early Diagnosis, Non-invasive Diagnosis, Serological, Prognosis, Chemotherapeutic Benefits
- Medical subject headings
- Cholangiocarcinoma, Klatskin Tumor, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsDiagnostic test
No interventions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malignant/Benign status of enrolled suspected cholangiocarcinoma patients by pathological examination
The pathological examination results of each enrolled patient will be recorded
Measured: 4 weeks
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chao Liu, PhD, Principal investigator, Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658587
- Sponsor's protocol ID
- SYSKY-2024-352-01
- Status last verified
- Oct 2024
- First submitted
- 11 Sep 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Accuracy of Novel Serological Risk Model in Early Diagnosis of Cholangiocarcinoma Patients
- ClinicalTrials.gov ID
- NCT06658587
- Acronym / sponsor ID
- SYSKY-2024-352-01
- Conditions
- Cholangiocarcinoma
- Keywords
- Hilar Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, Early Diagnosis, Non-invasive Diagnosis, Serological, Prognosis, Chemotherapeutic Benefits
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-sen University | – | Diagnostic Test: No interventionsThe cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is the exploration cohort. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had suspected cholangiocarcinoma and completed the blood collection before surgery
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionsNo interventions | Diagnostic test | Sun Yat-Sen Memorial Hospital of Sun Yat-sen University |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Liu, PhD principal investigator
Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiocarcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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 5 inclusion and 3 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 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Honghua Zhang, PhD (020-34078840, zhanghh68@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malignant/Benign status of enrolled suspected cholangiocarcinoma patients by pathological examination (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2024.