NCT06118463

Brief Summary

To detect the expression of AUNIP in cervical cancer serum, and to clarify its diagnostic and prognostic value.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2024

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jan 2024Jan 2029

First Submitted

Initial submission to the registry

October 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

3.8 years

First QC Date

October 31, 2023

Last Update Submit

November 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • AUNIP expression in serum

    Serum AUNIP expression is detected by ELISA kit. The results will be recorded seperately.

    through study completion, an average of 3 year

Study Arms (2)

study group

Women aged 20-60; There is a definite pathological diagnosis of cervical cancer

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.

Diagnostic Test: Detection of serum AUNIP expression

Interventions

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.

Healthy control groupstudy group

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • There are other lesions in the uterus and uterine adnexa
  • Pregnant, lactating or menarche women
  • Women who are undergoing human papillomavirus (HPV) vaccination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 31409573BACKGROUND
  • Ma 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.

    PMID: 33363020BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Lin Yuan, Ph.D.

    Qianfoshan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Yuan, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 7, 2023

Study Start

January 1, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

January 1, 2029

Last Updated

November 9, 2023

Record last verified: 2023-11