CholangiocarcinomaNCT05721963
Study on the Accuracy of Proteomics in Evaluating Lymph Node Metastasis Status in Cholangiocarcinoma Patients
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 single-center, prospective, observational and exploratory clinical study. The object of this study is to evaluate the accuracy of proteomics approaches on resected lymph node samples in evaluating lymph node metastasis status in cholangiocarcinoma patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangiocarcinoma
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Histologically confirmed cholangiocarcinoma patients who underwent radical resection and lymphadenectomy
Who may be able to join
- The patient must sign an informed consent form;
- Age 18-75 years old, both male and female;
- ECOG performance status score (PS score) 0-2;
- Child-Pugh score A period;
- Have not received any systemic treatment within 6 months;
- The functional indicators of important organs meet the following requirements (1)Neutrophils≥1.5*109/L; platelets≥100*109/L; hemoglobin≥9g/dl; serum albumin≥3g/dl; (2)Thyroid-stimulating hormone (TSH) ≤ 2 times the upper limit of normal, and T3 and T4 are in the normal range; (3)Bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST ≤ 3 times the upper limit of normal; (4)Serum creatinine ≤ 1.5 times the upper limit of normal, and creatinine clearance ≥ 60ml/min (calculated by Cockcroft-Gault formula);
- For women who are not breastfeeding or pregnant, use contraception during treatment or 12 months after the end of treatment.
Who cannot join
- Unresectable cholangiocarcinoma patients or postoperative diagnosis of cholangiocarcinoma recurrence and metastasis;
- Past or simultaneous suffering from other malignant tumors;
- Have used gemcitabine-based chemotherapy or radiotherapy within 6 months;
- Severe cardiopulmonary and renal dysfunction;
- Hypertension that is difficult to control with drugs (systolic blood pressure (BP) ≥140 mmHg and/or diastolic blood pressure ≥90mmHg) (based on the average of ≥3 BP readings obtained by ≥2 measurements);
- Abnormal coagulation function (PT>14s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy;
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- After antiviral treatment, HBV DNA>2000 copies/ml, HCV RNA>1000;
- A history of esophageal and gastric varices, significant clinically significant bleeding symptoms or a clear tendency to appear within 3 months before enrollment;
- Active infections requiring systemic treatment; patients with active tuberculosis infection within 1 year before enrollment; a history of active tuberculosis infection more than 1 year before enrollment, and no formal anti-tuberculosis treatment or tuberculosis Still in the active period;
- Human immunodeficiency virus (HIV, HIV1/2 antibody) positive;
- A history of psychotropic drug abuse, alcohol or drug abuse;
- Other factors judged by the investigator may affect the safety of the subjects or the compliance of the trial. Such as serious diseases (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
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 Proteomics in Evaluating Lymph Node Metastasis Status and Comparation With Pathological Examination in Cholangiocarcinoma Patients
This is a single-center, prospective, observational and exploratory clinical study. The object of this study is to evaluate the accuracy of proteomics approaches on resected lymph node samples in evaluating lymph node metastasis status in cholangiocarcinoma patients.
Read the detailed description
The current gold standard for the diagnosis of lymph node metastasis is pathological examination of surgically resected lymph node specimens. However, lymph node metastases are different from the primary lesions, and the distribution of tumor cells is heterogeneous and more dispersed. Therefore, a single thin pathological section is difficult to obtain complete information, which may be misdiagnosed due to the failure to examine on the section containing tumor cells or the presence of micro-metastases.
The application of proteomics can obtain the overall information of the samples, including the remodeling of the microenvironment by the tumor metastases and the acclimation even before the metastasis, resulting in significant changes in the protein expression profiles of the lymph nodes, which are difficult to be completely presented in conventional pathological sections. This study aims to evaluate the accuracy of proteomics approaches on resected lymph node samples in evaluating lymph node metastasis status in cholangiocarcinoma patients, assisting in guiding precision medicine and making therapeutic decisions.
Positive controls of lymph node metastases and negative controls of normal lymph nodes were previously profiled using proteomic approaches. Machine-learning clustering method will be used to classify the newly examined lymph nodes.
- Conditions
- Cholangiocarcinoma
- Being tested
- No interventions.
- Keywords
- Cholangiocarcinoma, Lymph Node Metastasis, Proteomics
- Medical subject headings
- Cholangiocarcinoma, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions.Diagnostic 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.
Lymph node metastasis status of each examined lymph nodes by pathological tests
The pathological examination results of each resected lymph nodes will be recorded
Measured: 1 month
Lymph node metastasis status of each lymph nodes evaluated by proteomic approaches
Machine-learning clustering will be applied to classify the lymph node metastasis status of each lymph nodes based on proteomic profiles
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Feb 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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
- 30 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
- NCT05721963
- Sponsor's protocol ID
- SYSKY-2023-087-01
- Status last verified
- Jan 2023
- First submitted
- 1 Feb 2023
- Last updated
- 10 Feb 2023
- 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 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Accuracy of Proteomics in Evaluating Lymph Node Metastasis Status and Comparation With Pathological Examination in Cholangiocarcinoma Patients
- ClinicalTrials.gov ID
- NCT05721963
- Acronym / sponsor ID
- SYSKY-2023-087-01
- Conditions
- Cholangiocarcinoma
- Keywords
- Cholangiocarcinoma, Lymph Node Metastasis, Proteomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Feb 2023 (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 single-center, prospective, observational and exploratory clinical study. The object of this study is to evaluate the accuracy of proteomics approaches on resected lymph node samples in evaluating lymph node metastasis status in cholangiocarcinoma patients.
Detailed description
The current gold standard for the diagnosis of lymph node metastasis is pathological examination of surgically resected lymph node specimens. However, lymph node metastases are different from the primary lesions, and the distribution of tumor cells is heterogeneous and more dispersed. Therefore, a single thin pathological section is difficult to obtain complete information, which may be misdiagnosed due to the failure to examine on the section containing tumor cells or the presence of micro-metastases.
The application of proteomics can obtain the overall information of the samples, including the remodeling of the microenvironment by the tumor metastases and the acclimation even before the metastasis, resulting in significant changes in the protein expression profiles of the lymph nodes, which are difficult to be completely presented in conventional pathological sections. This study aims to evaluate the accuracy of proteomics approaches on resected lymph node samples in evaluating lymph node metastasis status in cholangiocarcinoma patients, assisting in guiding precision medicine and making therapeutic decisions.
Positive controls of lymph node metastases and negative controls of normal lymph nodes were previously profiled using proteomic approaches. Machine-learning clustering method will be used to classify the newly examined lymph nodes.
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 interventions.The 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
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically confirmed cholangiocarcinoma patients who underwent radical resection and lymphadenectomy
Key inclusion criteria (7 listed)
- The patient must sign an informed consent form;
- Age 18-75 years old, both male and female;
- ECOG performance status score (PS score) 0-2;
- Child-Pugh score A period;
- Have not received any systemic treatment within 6 months;
Key exclusion criteria (12 listed)
- Unresectable cholangiocarcinoma patients or postoperative diagnosis of cholangiocarcinoma recurrence and metastasis;
- Past or simultaneous suffering from other malignant tumors;
- Have used gemcitabine-based chemotherapy or radiotherapy within 6 months;
- Severe cardiopulmonary and renal dysfunction;
- Hypertension that is difficult to control with drugs (systolic blood pressure (BP) ≥140 mmHg and/or diastolic blood pressure ≥90mmHg) (based on the average of ≥3 BP readings obtained by ≥2 measurements);
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 interventions.No interventions. | Diagnostic test | Sun Yat-Sen Memorial Hospital of Sun Yat-sen University |
Primary outcome
Lymph node metastasis status of each examined lymph nodes by pathological tests
Time frame: 1 month
The pathological examination results of each resected lymph nodes will be recorded
Lymph node metastasis status of each lymph nodes evaluated by proteomic approaches
Time frame: 2 month
Machine-learning clustering will be applied to classify the lymph node metastasis status of each lymph nodes based on proteomic profiles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- 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. This study is not recruiting at the moment.
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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 10 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Honghua Zhang, Dr (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?
Lymph node metastasis status of each examined lymph nodes by pathological tests (time frame: 1 month). 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 10 Feb 2023.