Laryngeal CarcinomaNCT06836765
The Relationship Between The Differential Expression Of FosB Protein In Laryngeal Cancer Tissues And Clinical Prognosis
An observational study of Laryngeal Carcinoma, run by Yang ji at 1 site in China.
Trial summary
To determine whether there is statisstical difference in FosB (FBJ murine osteosarcoma viral oncogene homolog B) protein expression between laryngeal cancer tissue and adjacent tissue through immunohistochemistry methods. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Laryngeal Carcinoma
- What is being tested?
- the expression negative in laryngeal cancer tissue and the expression positive in laryngeal cancer tissue
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 1 May 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 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Researchers are Collecting 100 to 200 cases of laryngeal cancer patients who have been finally diagnosed and treated in research institution.
Who may be able to join
- laryngeal squamous cell carcinoma was diagnosed ,and biopsy was confirmed by two pathologists;
- Primary tumor of Laryngeal ,and there was no distant metastasis;
- Standard treatment such as surgery and Preliminarily-diagnosed parients;
- full clinical and pathological data information and good follow-up;
- there was no previous fatal diseases such as complicated tumors.
Who cannot join
- Secondary cancer or cancer with distant metastasis;
- Patients who have not seen a doctor for the first time or have received surgery or radiotherapy or chemotherapy in other hospitals;
- Clinical and pathological data were missing and loss to follow-up;
- Patients who abandoned treatment or standard treatment procedures has not been completed;
- The past medical history of other lethal diseases such as complicated 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
Cllinical Laboratory of Chuanbei Medical College
Nanchong, China/SiChuan, 637000
Yang Ji, master, 0086+18283201832, 450638020@qq.com
About this study
Official title: Expression Of FosB Gene In Laryngeal Cancer Tissues And It's Clinical Prognosis Significance
To determine whether there is statisstical difference in FosB (FBJ murine osteosarcoma viral oncogene homolog B) protein expression between laryngeal cancer tissue and adjacent tissue through immunohistochemistry methods.
If there are differences, further the investigators will collect relevant patients information,such as clinical stages, pathological types, clinical prognosis and so on. ultimately analyze whether it is related to the expression of FOsB in laryngeal cancer tissue and adjacent tissues
Read the detailed description
First,the investigators will collect 100 to 200 cases of laryngeal cancer patients who have been finally diagnosed and treated in our institution in the past five years. Laryngeal cancer pathological tissues and adjacent tissues will be selected to make pathological sections. Use immunohistochemistry to confirm the differences in FosB protein between laryngeal cancer tissues and adjacent tissues, and clarify whether there are differences.
secondly,if there are differences, further the investigators will collect relevant patients information,such as clinical stages, pathological types, clinical prognosis and so on. Review the clinical data of corresponding patients, including age, gender, smoking and alcohol history, clinical stages, pathological types and clinical prognosis, etc., and compare whether there are statistical differences.
Finally, clinical prognostic data of relevant patients were collected through outpatient follow-up, online and telephone follow-up, to determine whether there is a correlation between Fosb expression in laryngeal cancer tissue and clinical prognosis.
- Conditions
- Laryngeal Carcinoma
- Being tested
- the expression negative in laryngeal cancer tissue, the expression positive in laryngeal cancer tissue
- Keywords
- Laryngeal cancer, FosB(FBJ murine osteosarcoma viral oncogene homolog B) gene, Immunohistochemistry, Cox regression analysis
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the expression negative in laryngeal cancer tissueOther
Researcher will incorporate the positive expression of FOSB protein in laryngeal cancer tissues into the positive study group and vice versa into the negative study group by immunohistochemical methods!
the expression positive in laryngeal cancer tissueOther
Researcher will incorporate the positive expression of FOSB protein in laryngeal cancer tissues into the positive study group and vice versa into the negative study group by immunohistochemical methods!
| Study group | Role | What they receive |
|---|---|---|
| The expression of FosB positive group | Researcher will incorporate the positive expression of FosB protein in laryngeal cancer tissues into the positive study group by immunohistochemical methods! Receives: Other: the expression positive in laryngeal cancer tissue | |
| The expression of FosB negative group | Researcher will incorporate the positive expression of FOSB protein in laryngeal cancer tissues into the positive study group and vice versa into the negative study group by immunohistochemical methods! Receives: Other: the expression negative in laryngeal cancer tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of fosb gene positive expression cases in laryngeal carcinoma cells and adjacent tissues was determined.
the number of fosb gene positive expression cases in laryngeal carcinoma cells and adjacent tissues was determined by immunohistochemical test of pathological sections.
Measured: one month
Secondary outcomes (1)
_Experimental result of western blot and PCR._Correlation analysis data between clinical information and experimental results..
Researcher will verify the effection of FosB gene on the proliferation and migration of Hep-2 laryngeal cancer cells through a series of basic experiments,such as Immunohistochemistry,western blot,PCR,and so on.clinical prognoostic information of patients was collected and the relationship with fosb gene expression was analyzed.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Laryngeal CarcinomaStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yang ji
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yang ji, Neijiang No.2 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836765
- Sponsor's protocol ID
- NeijiangPH2
- Status last verified
- Feb 2025
- First submitted
- 17 Aug 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu S, Luan J, Ding Y. miR-144-3p Targets FosB Proto-oncogene, AP-1 Transcription Factor Subunit (FOSB) to Suppress Proliferation, Migration, and Invasion of PANC-1 Pancreatic Cancer Cells. Oncol Res. 2018 Jun 11;26(5):683-690. doi: 10.3727/096504017X14982585511252. Epub 2017 Jun 24.
PubMed 28653602Hung YP, Fletcher CD, Hornick JL. FOSB is a Useful Diagnostic Marker for Pseudomyogenic Hemangioendothelioma. Am J Surg Pathol. 2017 May;41(5):596-606. doi: 10.1097/PAS.0000000000000795.
PubMed 28009608Eferl R, Wagner EF. AP-1: a double-edged sword in tumorigenesis. Nat Rev Cancer. 2003 Nov;3(11):859-68. doi: 10.1038/nrc1209. No abstract available.
PubMed 14668816
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression Of FosB Gene In Laryngeal Cancer Tissues And It's Clinical Prognosis Significance
- ClinicalTrials.gov ID
- NCT06836765
- Acronym / sponsor ID
- NeijiangPH2
- Conditions
- Laryngeal Carcinoma
- Keywords
- Laryngeal cancer, FosB(FBJ murine osteosarcoma viral oncogene homolog B) gene, Immunohistochemistry, Cox regression analysis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yang jiUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 20 Feb 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.
To determine whether there is statisstical difference in FosB (FBJ murine osteosarcoma viral oncogene homolog B) protein expression between laryngeal cancer tissue and adjacent tissue through immunohistochemistry methods.
If there are differences, further the investigators will collect relevant patients information,such as clinical stages, pathological types, clinical prognosis and so on. ultimately analyze whether it is related to the expression of FOsB in laryngeal cancer tissue and adjacent tissues
Detailed description
First,the investigators will collect 100 to 200 cases of laryngeal cancer patients who have been finally diagnosed and treated in our institution in the past five years. Laryngeal cancer pathological tissues and adjacent tissues will be selected to make pathological sections. Use immunohistochemistry to confirm the differences in FosB protein between laryngeal cancer tissues and adjacent tissues, and clarify whether there are differences.
secondly,if there are differences, further the investigators will collect relevant patients information,such as clinical stages, pathological types, clinical prognosis and so on. Review the clinical data of corresponding patients, including age, gender, smoking and alcohol history, clinical stages, pathological types and clinical prognosis, etc., and compare whether there are statistical differences.
Finally, clinical prognostic data of relevant patients were collected through outpatient follow-up, online and telephone follow-up, to determine whether there is a correlation between Fosb expression in laryngeal cancer tissue and clinical prognosis.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The expression of FosB positive group | – | Other: the expression positive in laryngeal cancer tissueResearcher will incorporate the positive expression of FosB protein in laryngeal cancer tissues into the positive study group by immunohistochemical methods! |
| The expression of FosB negative group | – | Other: the expression negative in laryngeal cancer tissueResearcher will incorporate the positive expression of FOSB protein in laryngeal cancer tissues into the positive study group and vice versa into the negative study group by immunohistochemical methods! |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Researchers are Collecting 100 to 200 cases of laryngeal cancer patients who have been finally diagnosed and treated in research institution.
Key inclusion criteria (5 listed)
- laryngeal squamous cell carcinoma was diagnosed ,and biopsy was confirmed by two pathologists;
- Primary tumor of Laryngeal ,and there was no distant metastasis;
- Standard treatment such as surgery and Preliminarily-diagnosed parients;
- full clinical and pathological data information and good follow-up;
- there was no previous fatal diseases such as complicated tumors.
Key exclusion criteria (5 listed)
- Secondary cancer or cancer with distant metastasis;
- Patients who have not seen a doctor for the first time or have received surgery or radiotherapy or chemotherapy in other hospitals;
- Clinical and pathological data were missing and loss to follow-up;
- Patients who abandoned treatment or standard treatment procedures has not been completed;
- The past medical history of other lethal diseases such as complicated tumors.
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 |
|---|---|---|
| the expression negative in laryngeal cancer tissueResearcher will incorporate the positive expression of FOSB protein in laryngeal cancer tissues into the positive study group and vice versa into the negative study group by immunohistochemical methods! | Other | The expression of FosB negative group |
| the expression positive in laryngeal cancer tissueResearcher will incorporate the positive expression of FOSB protein in laryngeal cancer tissues into the positive study group and vice versa into the negative study group by immunohistochemical methods! | Other | The expression of FosB positive group |
Primary outcome
the number of fosb gene positive expression cases in laryngeal carcinoma cells and adjacent tissues was determined.
Time frame: one month
the number of fosb gene positive expression cases in laryngeal carcinoma cells and adjacent tissues was determined by immunohistochemical test of pathological sections.
1 secondary outcome
_Experimental result of western blot and PCR._Correlation analysis data between clinical information and experimental results..
Time frame: three months
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 20 Feb 2025.
- Background: PubMed 28653602Liu S, Luan J, Ding Y. miR-144-3p Targets FosB Proto-oncogene, AP-1 Transcription Factor Subunit (FOSB) to Suppress Proliferation, Migration, and Invasion of PANC-1 Pancreatic Cancer Cells. Oncol Res. 2018 Jun 11;26(5):683-690. doi: 10.3727/096504017X14982585511252. Epub 2017 Jun 24.
- Background: PubMed 28009608Hung YP, Fletcher CD, Hornick JL. FOSB is a Useful Diagnostic Marker for Pseudomyogenic Hemangioendothelioma. Am J Surg Pathol. 2017 May;41(5):596-606. doi: 10.1097/PAS.0000000000000795.
- Results publication: PubMed 14668816Eferl R, Wagner EF. AP-1: a double-edged sword in tumorigenesis. Nat Rev Cancer. 2003 Nov;3(11):859-68. doi: 10.1038/nrc1209. No abstract available.
- Individual participant dataSharing planned: No
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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 Laryngeal Carcinoma, run by Yang ji 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 5 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: opening soon, as of the sponsor's last update on 20 Feb 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 Yang Ji (+86 18283201832, 450638020@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of fosb gene positive expression cases in laryngeal carcinoma cells and adjacent tissues was determined. (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06836765, which also lists 3 linked publications.
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 20 Feb 2025.