NCT05789628

Brief Summary

The percentages of participants in clinical studies haven't always been perfectly representative of a particular group. This research examines the variables that affect a patient's choice to enroll in, discontinue participation in, or resume participation in a clinical trial for cervical cancer. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future cervical cancer studies.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

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

First Submitted

Initial submission to the registry

March 16, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

March 16, 2023

Last Update Submit

March 16, 2023

Conditions

Keywords

Cervical Cancer

Outcome Measures

Primary Outcomes (2)

  • Rate of patients who decide to enroll in a cervical cancer clinical study.

    3 months

  • Number of cervical cancer study participants who remain in clinical trial until completion.

    12 months

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who are actively considering involvement in an observational cervical cancer clinical trial, but have not yet completed enrollment and registration.

You may qualify if:

  • Aged ≥ 18 years old
  • Ability to understand and the willingness to sign a written informed consent document.
  • Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

You may not qualify if:

  • Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
  • Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
  • Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Hu L, Bell D, Antani S, Xue Z, Yu K, Horning MP, Gachuhi N, Wilson B, Jaiswal MS, Befano B, Long LR, Herrero R, Einstein MH, Burk RD, Demarco M, Gage JC, Rodriguez AC, Wentzensen N, Schiffman M. An Observational Study of Deep Learning and Automated Evaluation of Cervical Images for Cancer Screening. J Natl Cancer Inst. 2019 Sep 1;111(9):923-932. doi: 10.1093/jnci/djy225.

    PMID: 30629194BACKGROUND
  • Peirson L, Fitzpatrick-Lewis D, Ciliska D, Warren R. Screening for cervical cancer: a systematic review and meta-analysis. Syst Rev. 2013 May 24;2:35. doi: 10.1186/2046-4053-2-35.

    PMID: 23706117BACKGROUND
  • Saei Ghare Naz M, Kariman N, Ebadi A, Ozgoli G, Ghasemi V, Rashidi Fakari F. Educational Interventions for Cervical Cancer Screening Behavior of Women: A Systematic Review. Asian Pac J Cancer Prev. 2018 Apr 25;19(4):875-884. doi: 10.22034/APJCP.2018.19.4.875.

    PMID: 29693331BACKGROUND

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

  • Michael B Gill

    Power Life Sciences Inc.

    STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2023

First Posted

March 29, 2023

Study Start

April 1, 2024

Primary Completion

April 1, 2025

Study Completion

April 1, 2026

Last Updated

March 29, 2023

Record last verified: 2023-03