NCT03188315

Brief Summary

Cancer is a devastating disease, presenting an immense disease burden to affected individuals and their families as well as health care systems with 10.9 million new cases and 6.7 million deaths per year. Approximately 12% of human cancers worldwide are caused by oncoviruses infection with more than 80% of cases occurring in the developing world. Tumor viruses can be classified into two groups based on their genetic material;

  1. 1.DNA tumor viruses:
  2. 2.Small DNA tumor viruses (Papilloma viruses, Polyoma viruses and adenoviruses).
  3. 3.Complex DNA tumor viruses (Herpes viruses and Hepatitis B viruses).
  4. 4.RNA tumor viruses ( Hepatitis C viruses and human T-cell leukemia virus "HTLV").

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Status
unknown

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

June 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

June 15, 2017

Status Verified

June 1, 2017

Enrollment Period

6 months

First QC Date

June 13, 2017

Last Update Submit

June 14, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • carcinogenesis

    developing cancer cervix

    6 months

Study Arms (2)

cases

EXPERIMENTAL

HPV detection HPV Genotyping HPV Oncogenes and oncoproteins

Genetic: HPV oncogenes

control

ACTIVE COMPARATOR

HPV detection HPV Genotyping HPV Oncogenes and oncoproteins

Genetic: HPV oncogenes

Interventions

PCR and oncogenes detection

casescontrol

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 - 65 years old.
  • Women who are positive for HPV diagnosed by routine screening.
  • Women willing to participate in the study and sign an informed consent

You may not qualify if:

  • Age extremes (less than 18 years old or more than 65 years old).
  • Immuno-comprised patients, patients under steroid therapy or chemotherapy, or patients with serious medical illness that could affect their immune system.
  • Unknown medical history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DNA Virus Infections

Condition Hierarchy (Ancestors)

Virus DiseasesInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 15, 2017

Study Start

September 1, 2017

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

June 15, 2017

Record last verified: 2017-06