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

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ClinicalTrials.gov Identifier: NCT05969262
Recruitment Status : Recruiting
First Posted : August 1, 2023
Last Update Posted : August 3, 2023
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital, Southern Medical University

Study Description
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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.

Condition or disease Intervention/treatment
Head and Neck Cancer Metabolite Diagnostic Test: Proteomics technology and liquid biopsy

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 3 Years
Official Title: A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites During the Occurrence and Development of Head and Neck Cancer in Southern China
Actual Study Start Date : March 25, 2023
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Achieve the expected number of enrolled cases [ Time Frame: 3 years ]
    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.


Biospecimen Retention:   Samples With DNA
Plasma and Urine

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05969262


Locations
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China, Guangdong
Southern medical university Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Jian Guan, M.D.    86+13632102247    guanjian5461@163.com   
Principal Investigator: Jian Guan, M.D.         
Sponsors and Collaborators
Nanfang Hospital, Southern Medical University
More Information
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Responsible Party: Nanfang Hospital, Southern Medical University
ClinicalTrials.gov Identifier: NCT05969262    
Other Study ID Numbers: NFEC-2023-123
First Posted: August 1, 2023    Key Record Dates
Last Update Posted: August 3, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms