NCT04974424

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

2.9 years

First QC Date

June 24, 2021

Last Update Submit

July 13, 2021

Conditions

Uterine Cervical NeoplasmUterine Cervical CancerCervical Cancer

Outcome Measures

Primary Outcomes (1)

  • Significant loci of genetic variation

    The impact of genetic variance on predisposition to cervical cancer

    2

Eligibility Criteria

Age25 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chinese population

You may qualify if:

  • (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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430000, China

RECRUITING

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

  • Ding Ma, MD, PhD

    Huazhong University of Science and Technology

    STUDY CHAIR

Central Study Contacts

Ding Ma, MD, PhD

CONTACT

0086-27-836268dma@tjh.tjmu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College

Study Record Dates

First Submitted

June 24, 2021

First Posted

July 23, 2021

Study Start

January 1, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

July 23, 2021

Record last verified: 2021-07

Locations

CN(1)