Studies of Small DNA Virus Encoded Oncogenes in Viral Carcinogenesis Using Laboratory Model Systems
Primary Purpose
DNA Virus Infections
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HPV oncogenes
Sponsored by
About this trial
This is an interventional basic science trial for DNA Virus Infections
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
cases
control
Arm Description
HPV detection HPV Genotyping HPV Oncogenes and oncoproteins
HPV detection HPV Genotyping HPV Oncogenes and oncoproteins
Outcomes
Primary Outcome Measures
carcinogenesis
developing cancer cervix
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03188315
Brief Title
Studies of Small DNA Virus Encoded Oncogenes in Viral Carcinogenesis Using Laboratory Model Systems
Official Title
Studies of Small DNA Virus Encoded Oncogenes in Viral Carcinogenesis Using Laboratory Model Systems
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Anticipated)
Primary Completion Date
February 28, 2018 (Anticipated)
Study Completion Date
February 28, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Heba Momen kamel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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;
DNA tumor viruses:
Small DNA tumor viruses (Papilloma viruses, Polyoma viruses and adenoviruses).
Complex DNA tumor viruses (Herpes viruses and Hepatitis B viruses).
RNA tumor viruses ( Hepatitis C viruses and human T-cell leukemia virus "HTLV").
There are around 100 types of HPV, with different variations in their genetic and oncogenic potential [5]. Thus, HPV genotypes are divided into 2 groups based on their vulnerability; High risk HPV (HR-HPV) and low risk HPV (LR-HPV).
The HPV genome encodes several oncoproteins [5]. E6 and E7 are the main genes responsible for cell transformation mediated by HR-HPV, and they modulate the activities of cellular proteins that regulate the cell cycle. Thus, the presence of E6/E7 can be a specific marker for diagnosing precancerous lesions by HPV.
Knowledge of the etiology of virus-mediated carcinogenesis, the networking of pathways involved in the transition from infection to cancer and the risk factors associated with each type of cancer, all suggest prophylactic and therapeutic strategies that may reduce the risk of virus-mediated cancer.
Detailed Description
Study subjects:
Inclusion criteria:
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
Exclusion criteria:
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.
Study Groups:
Group 1 (Cases): Patients known to have Cancer cervix with any degree of malignancy (diagnosed by routine screening or any other diagnostic tests)
Group 2 (Controls): Women sharing the same inclusion and exclusion criteria, but not known to have Cancer cervix
Aim of The Study:
Studying the role of HPV as an example of small DNA viruses in cell transformation and carcinogenesis.
Determining the most HPV genotypes associated with high risks of cancer cervix occurrence.
Detection of the HPV oncogenes playing role cell transformation and malignancy.
Studying the role of viral DNA integration in cellular transformation and carcinogenesis.
Study methods:
Samples collection and storing:
• Samples will be obtained from the cervix with the brush or swab\ by following the instructions corresponding to the type of collecting device.
• Collection tubes will be stored at room temperature (15-30 °C).
Samples will be sent to the laboratory in less than 14 days following collection
The tubes can be preserved for 2-3 weeks at room temperature.
HPV detection:
HPV cannot be propagated in tissue culture, and therefore, in most cases its accurate identification relies on molecular biology techniques, such as polymerase chain reaction (PCR).
HPV Genotyping:
• PCR-RFLP shows good discriminatory power by differentiating between HR and LR HPV genotypes, and it is possible to identify single or multiple infections .
• In this technique, the amplified DNA is digested by restriction enzymes, resulting in DNA fragments of various lengths. Each fragment length is characteristic of a certain HPV genotype.
• The commonest restriction enzymes are BamHI, Dd6eI, HaeIII, HinfI, PstI and RsaI.
HPV Oncogenes and oncoproteins:
• The main techniques used to detect mRNA for E6/E7 oncogenes are two commercial assays: PreTectW Proofer and APTIMAW HPV Assay. These techniques are based on transcription-mediated amplification of full-length E6/E7 transcripts using PCR.
Statistical analysis:
• Data will be analyzed by one-way analysis of variance using SPSS software version 24.0. Values will be expressed as mean ± S.D. For comparison between 2 groups, Student's t test will be used to determine whether the cases was significantly different from the control. Differences will be considered statistically significant at P<0.05, while P<0.01 will represent more significant change.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DNA Virus Infections
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cases
Arm Type
Experimental
Arm Description
HPV detection HPV Genotyping HPV Oncogenes and oncoproteins
Arm Title
control
Arm Type
Active Comparator
Arm Description
HPV detection HPV Genotyping HPV Oncogenes and oncoproteins
Intervention Type
Genetic
Intervention Name(s)
HPV oncogenes
Intervention Description
PCR and oncogenes detection
Primary Outcome Measure Information:
Title
carcinogenesis
Description
developing cancer cervix
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Studies of Small DNA Virus Encoded Oncogenes in Viral Carcinogenesis Using Laboratory Model Systems
We'll reach out to this number within 24 hrs