Head and Neck CancerNCT05969262
A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites of Head and Neck Cancer
An observational study of Head and Neck Cancer and Metabolite, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancer, Metabolite
- What is being tested?
- Proteomics technology and liquid biopsy
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2023to 1 Jun 2025
- How long will I take part?
- 3 Years
- 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
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southern medical university
Guangzhou, Guangdong, 510515
Jian Guan, M.D., 86+13632102247, guanjian5461@163.com
Jian Guan, M.D.
About this study
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
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.
Read the 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.
- Conditions
- Head and Neck Cancer, Metabolite
- Being tested
- Proteomics technology and liquid biopsy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proteomics technology and liquid biopsyDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Head and neck cancer patients | Patients who meet the diagnostic criteria of the Guidelines for Diagnosis and Treatment of Head and Neck Cancer Receives: 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. Receives: Diagnostic Test: Proteomics technology and liquid biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieve the expected number of enrolled cases
- Retrospective cohort: 250 patients were recruited, including 125 patients with head and neck cancer, 125 healthy people.
- Prospective cohort: 250 patients were recruited, including 125 head and neck cancer patients and 125 healthy people.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start25 Mar 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969262
- Sponsor's protocol ID
- NFEC-2023-123
- Status last verified
- Aug 2023
- First submitted
- 24 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05969262
- Acronym / sponsor ID
- NFEC-2023-123
- Conditions
- Head and Neck Cancer, Metabolite
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 25 Mar 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 1 Aug 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head and neck cancer patients | – | Diagnostic Test: Proteomics technology and liquid biopsyPatients who meet the diagnostic criteria of the Guidelines for Diagnosis and Treatment of Head and Neck Cancer |
| Healthy people | – | Diagnostic Test: Proteomics technology and liquid biopsyHealthy people without liver related medical history or other diseases known to affect blood lipid/protein metabolism. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- Head and neck cancer patients
- Healthy people
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Proteomics technology and liquid biopsyusing 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 | Diagnostic test | Head and neck cancer patients, Healthy people |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
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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.
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 Head and Neck Cancer and Metabolite, run by Nanfang Hospital, Southern Medical 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 10 inclusion and 5 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 3 Aug 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieve the expected number of enrolled cases (time frame: 3 years). 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 3 Aug 2023.