Early Warning Model of Susceptibility and High-risk Population of Cervical Cancer Related to HPV

Study on Early Warning Model of Susceptibility and High-risk Population of Cervical Cancer Related to HPV

Most uterine cervical high-risk human papillomavirus (HPV) infections are transient, with only a small fraction developing into cervical cancer. Family aggregation studies and heritability estimates suggest a significant inherited genetic component. Candidate gene studies and previous genome-wide association studies (GWASs) report associations between the HLA region and cervical cancer. Adopting a genome-wide approach, we aimed to establish an early warning model for a high-risk population of cervical cancer.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer; Uterine Cervical Cancer; Uterine Cervical Neoplasm

• Study Type: Observational
• Enrollment (Anticipated): 20000

Contacts and Locations

• Study Contact: Name: Ding Ma, MD, PhD; Phone Number: 0086-27-836268; Email: dma@tjh.tjmu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Tongji Hospital
      • Contact: Ding Ma, MD; Phone Number: 0086-27-8362681; Email: dma@tjh.tjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Chinese population

Description

Inclusion Criteria:

• (1) Case group a) Aged 25-75 years. b) Han nationality. c) Patients with cervical cancer or cervical precancerous lesions above CIN2 diagnosed by biopsy or postoperative pathological diagnosis.
• (2) Control group: a) Aged 25-75 years. b) Han nationality. c) No family history of cervical cancer or precancerous lesions. d) The results of TCT examination showed no abnormality.

Exclusion Criteria:

• (1) suffering from other neoplastic diseases.
• (2) pregnant women.
• (3) those with a history of bone marrow transplantation.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Significant loci of genetic variation	The impact of genetic variance on predisposition to cervical cancer	2

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Collaborators: Qilu Hospital of Shandong University; Third Military Medical University; Women's Hospital School Of Medicine Zhejiang University; Shenzhen Second People's Hospital; Obstetrics & Gynecology Hospital of Fudan University; Wuhan Central Hospital; Xiangyang Central Hospital
• Investigators: Study Chair: Ding Ma, MD, PhD, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: S160

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No