Study on AUNIP as a Novel Tumor Marker for Cervical Cancer

November 6, 2023 updated by: Lin Yuan
To detect the expression of AUNIP in cervical cancer serum, and to clarify its diagnostic and prognostic value.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Exclusion criteria of the study group:

  • There are other lesions in the uterus and uterine adnexa

Exclusion criteria of healthy control group:

  • Pregnant, lactating or menarche women
  • Women who are undergoing human papillomavirus (HPV) vaccination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
study group
Women aged 20-60; There is a definite pathological diagnosis of cervical cancer
Diagnostic test: Detection of serum AUNIP expression
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 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lin Yuan

Investigators

  • Principal Investigator: Lin Yuan, Ph.D., Qianfoshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

October 31, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yl20231001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The plan will be shared after the clinial trial is completed and the patent protection is obtained.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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