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Trial Title:
A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites of Head and Neck Cancer
NCT ID:
NCT05969262
Condition:
Head and Neck Cancer
Metabolite
Conditions: Official terms:
Head and Neck Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Proteomics technology and liquid biopsy
Description:
using proteomics technology and liquid biopsy to investigate the changes of plasma and
urine metabolites in different liver diseases during the development of liver cancer by
collecting residual blood and urine from routine diagnosis and treatment or physical
examination
Arm group label:
Head and neck cancer patients
Arm group label:
Healthy people
Summary:
Dynamic changes in the internal environment of the body are important clues for early
detection, diagnosis and even cure of head and neck tumors. This project uses the
combination of proteomics technology and liquid biopsy to provide more primary prevention
strategies for early intervention, secondary prevention strategies for early detection
and treatment, and clues for the study of the mechanism of dynamic evolution of head and
neck tumors.
Detailed description:
Head and neck cancer is the seventh most common malignant tumor in the world, and China
is a country with a high incidence of head and neck cancer. Dynamic changes in the
internal environment of the body are important clues for early detection, diagnosis and
even cure of head and neck tumors. The occurrence and development of head and neck cancer
is complex, so it is particularly important to explore the changes of internal
environment in its clinical pathway. Therefore, we conducted this study to investigate
the changes of plasma and urine metabolites during the development of head and neck
cancer.
(1) Retrospective cohort: 250 patients were recruited, including 125 patients with Head
and neck cancer and 125 healthy people.,(2) Prospective cohort: 250 patients were
recruited, including 125 head and neck cancer patients and 125 healthy people. During the
course of the study, the subjects will not be given or provided with any randomized or
any treatment driven by the study protocol. If it is clinically applicable, the treatment
physician shall make the treatment decision and choose the treatment plan at his
discretion.
Criteria for eligibility:
Study pop:
Subjects who met the diagnosis and criteria of head and neck cancer and were hospitalized
in Southern Hospital of Southern Medical University.Subjects agreed to participate in the
study and signed the informed consent form.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Head and neck cancer patients
- Age 18-75 years old;
- Male or non-pregnant female;
- Patients who were normatively diagnosed as head and neck tumors according to
the WHO standards of 2017;
- The general situation is good: KPS score ≥70;
- No other malignant tumors.
2. Healthy people
- Age 18-75 years old;
- Male or non-pregnant female;
- No history of head and neck related diseases or other diseases known to affect
blood lipid/protein metabolism.
Exclusion Criteria:
- Previous history of non-research related head and neck conditions or other known
effects on blood metabolism (except for controlled type 2 diabetes);
- With a history of other malignancies (except cell carcinoma and cervical carcinoma
in situ);
- Diseases that require long-term use of immunosuppressive drugs (including steroids),
including but not limited to congenital or acquired immunodeficiency disorders or
active central nervous system rotations, metastatic cancer, active infection, or
uncontrolled heart disease;
- Concurrent with other uncontrolled serious medical conditions, such as unstable
heart disease that requires treatment Disease, poorly controlled diabetes (fasting
blood glucose > 1.5× the upper limit of normal), mental illness and a history of
severe allergies.
- BMI less than 18 or greater than 25.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Locations:
Facility:
Name:
Southern medical university
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Guan, M.D.
Phone:
86+13632102247
Email:
guanjian5461@163.com
Investigator:
Last name:
Jian Guan, M.D.
Email:
Principal Investigator
Start date:
March 25, 2023
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05969262
