A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites of Head and Neck Cancer

NCT05969262 | Unknown

• 1 other identifier: NFEC-2023-123
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer; Metabolite

Outcome Measures

Primary Outcomes (1)

• Achieve the expected number of enrolled cases

  1. Retrospective cohort: 250 patients were recruited, including 125 patients with head and neck cancer, 125 healthy people. 2. Prospective cohort: 250 patients were recruited, including 125 head and neck cancer patients and 125 healthy people.

  3 years

Study Arms (2)

Head and neck cancer patients

Patients who meet the diagnostic criteria of the Guidelines for Diagnosis and Treatment of Head and Neck Cancer

Diagnostic Test: Proteomics technology and liquid biopsy

Healthy people

Healthy people without liver related medical history or other diseases known to affect blood lipid/protein metabolism.

Diagnostic Test: Proteomics technology and liquid biopsy

Interventions

Proteomics technology and liquid biopsy DIAGNOSTIC_TEST

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

Head and neck cancer patients; Healthy people

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Southern medical university

Guangzhou, Guangdong, 510515, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and Urine

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: March 25, 2023
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

CN (1)