Cervical CancerNCT06118463
Study on AUNIP as a Novel Tumor Marker for Cervical Cancer
An observational study of Cervical Cancer, run by Lin Yuan.
Trial summary
To detect the expression of AUNIP in cervical cancer serum, and to clarify its diagnostic and prognostic value. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Detection of serum AUNIP expression
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Jan 2029
- 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 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: In this study, 150 patients with cervical cancer in the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital) are selected as the study group. 150 healthy women are taken as control group during the same period.
Who may be able to join
- Study group inclusion criteria:
- Women aged 20-60
- There is a definite pathological diagnosis of cervical cancer
- Healthy control group:
- Women aged 20-60
- No tumors in the uterus or other parts of the body
- No inflammatory disease
- Blood routine and blood biochemical tests are normal
Who cannot join
- There are other lesions in the uterus and uterine adnexa
- Pregnant, lactating or menarche women
- Women who are undergoing human papillomavirus (HPV) vaccination
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To detect the expression of AUNIP in cervical cancer serum, and to clarify its diagnostic and prognostic value.
Read the detailed description
Blood of all study participants of cervical cancer patients are collected to detect the expression of AUNIP, analyze the statistical correlation between the expression of cervical cancer AUNIP and clinicopathological parameters of patients, and preliminarily understand the expression of AUNIP in cervical cancer tumor tissues and its clinical diagnostic and progniostic value.
- Conditions
- Cervical Cancer
- Being tested
- Detection of serum AUNIP expression
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of serum AUNIP expressionDiagnostic test
The experiment is carried out according to the ELISA kit instructions, and the absorbance optic density (OD) value of the enzyme labeler at 450 nm is read. The protein concentration of AUNIP in the serum sample is calculated according to the standard curve.
| Study group | Role | What they receive |
|---|---|---|
| study group | Women aged 20-60; There is a definite pathological diagnosis of cervical cancer Receives: Diagnostic Test: Detection of serum AUNIP expression | |
| Healthy control group | Women aged 20-60; No tumors in the uterus or other parts of the body; No inflammatory disease; Blood routine and blood biochemical tests are normal. Receives: Diagnostic Test: Detection of serum AUNIP expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUNIP expression in serum
Serum AUNIP expression is detected by ELISA kit. The results will be recorded seperately.
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lin Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lin Yuan, Qianfoshan Hospital
- Investigators
- Lin Yuan, Ph.D., Principal investigator, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118463
- Sponsor's protocol ID
- yl20231001
- Status last verified
- Nov 2023
- First submitted
- 31 Oct 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan will be shared after the clinial trial is completed and the patent protection is obtained.
Publications
Yang Z, Liang X, Fu Y, Liu Y, Zheng L, Liu F, Li T, Yin X, Qiao X, Xu X. Identification of AUNIP as a candidate diagnostic and prognostic biomarker for oral squamous cell carcinoma. EBioMedicine. 2019 Sep;47:44-57. doi: 10.1016/j.ebiom.2019.08.013. Epub 2019 Aug 10.
PubMed 31409573Ma C, Kang W, Yu L, Yang Z, Ding T. AUNIP Expression Is Correlated With Immune Infiltration and Is a Candidate Diagnostic and Prognostic Biomarker for Hepatocellular Carcinoma and Lung Adenocarcinoma. Front Oncol. 2020 Dec 9;10:590006. doi: 10.3389/fonc.2020.590006. eCollection 2020.
PubMed 33363020
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on AUNIP as a Novel Tumor Marker for Cervical Cancer
- ClinicalTrials.gov ID
- NCT06118463
- Acronym / sponsor ID
- yl20231001
- Conditions
- Cervical Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Lin YuanUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 7 Nov 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.
To detect the expression of AUNIP in cervical cancer serum, and to clarify its diagnostic and prognostic value.
Detailed description
Blood of all study participants of cervical cancer patients are collected to detect the expression of AUNIP, analyze the statistical correlation between the expression of cervical cancer AUNIP and clinicopathological parameters of patients, and preliminarily understand the expression of AUNIP in cervical cancer tumor tissues and its clinical diagnostic and progniostic value.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: Detection of serum AUNIP expressionWomen aged 20-60; There is a definite pathological diagnosis of cervical cancer |
| Healthy control group | – | Diagnostic Test: Detection of serum AUNIP expressionWomen aged 20-60; No tumors in the uterus or other parts of the body; No inflammatory disease; Blood routine and blood biochemical tests are normal. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- In this study, 150 patients with cervical cancer in the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital) are selected as the study group. 150 healthy women are taken as control group during the same period.
Key inclusion criteria (8 listed)
- Women aged 20-60
- There is a definite pathological diagnosis of cervical cancer
- Women aged 20-60
- No tumors in the uterus or other parts of the body
- No inflammatory disease
Key exclusion criteria (3 listed)
- There are other lesions in the uterus and uterine adnexa
- Pregnant, lactating or menarche women
- Women who are undergoing human papillomavirus (HPV) vaccination
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 |
|---|---|---|
| Detection of serum AUNIP expressionThe experiment is carried out according to the ELISA kit instructions, and the absorbance optic density (OD) value of the enzyme labeler at 450 nm is read. The protein concentration of AUNIP in the serum sample is calculated according to the standard curve. | Diagnostic test | Healthy control group, study group |
Primary outcome
AUNIP expression in serum
Time frame: through study completion, an average of 3 year
Serum AUNIP expression is detected by ELISA kit. The results will be recorded seperately.
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 9 Nov 2023.
- Background: PubMed 31409573Yang Z, Liang X, Fu Y, Liu Y, Zheng L, Liu F, Li T, Yin X, Qiao X, Xu X. Identification of AUNIP as a candidate diagnostic and prognostic biomarker for oral squamous cell carcinoma. EBioMedicine. 2019 Sep;47:44-57. doi: 10.1016/j.ebiom.2019.08.013. Epub 2019 Aug 10.
- Background: PubMed 33363020Ma C, Kang W, Yu L, Yang Z, Ding T. AUNIP Expression Is Correlated With Immune Infiltration and Is a Candidate Diagnostic and Prognostic Biomarker for Hepatocellular Carcinoma and Lung Adenocarcinoma. Front Oncol. 2020 Dec 9;10:590006. doi: 10.3389/fonc.2020.590006. eCollection 2020.
- Individual participant dataSharing planned: Undecided. The plan will be shared after the clinial trial is completed and the patent protection is obtained.
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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.
Lin Yuan, Ph.D. principal investigator
Qianfoshan Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by Lin Yuan.
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 8 inclusion and 3 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 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Lin Yuan, Ph.D. (0531-89269678, yuanl@sdfmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUNIP expression in serum (time frame: through study completion, an average of 3 year). 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 NCT06118463, which also lists 2 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 9 Nov 2023.