Head and Neck CancerNCT07027280
Noninvasive Intratumor Heterogeneity Evaluation in HNSCC
An observational study of Head and Neck Cancer, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This study focuses on tumor heterogeneity, a core challenge in the field of oncology, and innovatively utilizes patient imaging data to deeply mine and analyze intratumoral heterogeneity. Read more about this study
- Who is it for?
- Ages 15 to 89 years
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2025to 15 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with pathologically confirmed HNSCC were collected from the Department of Otolaryngology, the First Affiliated Hospital of Chongqing Medical University.
Who may be able to join
- Pathologically confirmed head and neck squamous cell carcinoma (HNSCC). Complete clinical, imaging, and pathological data. Available complete follow-up information.
Who cannot join
- Patients who received chemotherapy or radiotherapy before surgery. Poor image quality. Tumors too small to be easily identified. History of other concurrent malignant tumors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
xinwei chen, 15178870590, cxw9977@163.com
About this study
Official title: Noninvasive Intratumor Heterogeneity Evaluation in HNSCC With Multi-omics Insights and Therapeutic Targets
This study focuses on tumor heterogeneity, a core challenge in the field of oncology, and innovatively utilizes patient imaging data to deeply mine and analyze intratumoral heterogeneity. By constructing an imaging analysis model for tumor heterogeneity and associating this model with clinical, pathological, transcriptomic, and metabolomic data of patients, a multi-omics decoding of tumor heterogeneity is achieved. The main questions it aims to address are:
Can the ITH model stratify patients' treatment efficacy and prognosis assessment? Can pathological and multi-omics sequencing map the mechanisms behind the ITH model?
- Conditions
- Head and Neck Cancer
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Training set | Not described | |
| Test set | Not described | |
| Pathological set | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Measured: through study completion, an average of 1 year
C-index
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start27 Feb 2025
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Aug 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
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xinwei Chen, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027280
- Sponsor's protocol ID
- xChen
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to the high emphasis on patient privacy protection, there is currently no information about public availability of the dataset in this study. After the relevant articles of this study are officially published, peers can apply to obtain the research data from the corresponding author for legitimate scientific research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Intratumor Heterogeneity Evaluation in HNSCC With Multi-omics Insights and Therapeutic Targets
- ClinicalTrials.gov ID
- NCT07027280
- Acronym / sponsor ID
- xChen
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 18 Jun 2025 (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.
This study focuses on tumor heterogeneity, a core challenge in the field of oncology, and innovatively utilizes patient imaging data to deeply mine and analyze intratumoral heterogeneity. By constructing an imaging analysis model for tumor heterogeneity and associating this model with clinical, pathological, transcriptomic, and metabolomic data of patients, a multi-omics decoding of tumor heterogeneity is achieved. The main questions it aims to address are:
Can the ITH model stratify patients' treatment efficacy and prognosis assessment? Can pathological and multi-omics sequencing map the mechanisms behind the ITH model?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training set | – | – |
| Test set | – | – |
| Pathological set | – | – |
Who may qualify
- Ages
- 15 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pathologically confirmed HNSCC were collected from the Department of Otolaryngology, the First Affiliated Hospital of Chongqing Medical University.
Key inclusion criteria (1 listed)
- Pathologically confirmed head and neck squamous cell carcinoma (HNSCC). Complete clinical, imaging, and pathological data. Available complete follow-up information.
Key exclusion criteria (1 listed)
- Patients who received chemotherapy or radiotherapy before surgery. Poor image quality. Tumors too small to be easily identified. History of other concurrent malignant tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AUC
Time frame: through study completion, an average of 1 year
C-index
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: Undecided. Due to the high emphasis on patient privacy protection, there is currently no information about public availability of the dataset in this study. After the relevant articles of this study are officially published, peers can apply to obtain the research data from the corresponding author for legitimate scientific research purposes.
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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.
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, run by First Affiliated Hospital of Chongqing 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 18 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xinwei Chen (+8615178870590, cxw9977@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 18 Jun 2025.