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Trial Title:
Study on the Accuracy of Proteomics in Evaluating Lymph Node Metastasis Status in Cholangiocarcinoma Patients
NCT ID:
NCT05721963
Condition:
Cholangiocarcinoma
Conditions: Official terms:
Neoplasm Metastasis
Cholangiocarcinoma
Lymphatic Metastasis
Conditions: Keywords:
Cholangiocarcinoma
Lymph Node Metastasis
Proteomics
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
No interventions.
Description:
No interventions.
Arm group label:
Sun Yat-Sen Memorial Hospital of Sun Yat-sen University
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.
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.
Criteria for eligibility:
Study pop:
Histologically confirmed cholangiocarcinoma patients who underwent radical resection and
lymphadenectomy
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510220
Country:
China
Status:
Recruiting
Contact:
Last name:
Honghua Zhang, PhD
Phone:
020-34078840
Email:
zhanghh68@mail.sysu.edu.cn
Start date:
February 1, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05721963
