DNA Virus InfectionsNCT03188315
Studies of Small DNA Virus Encoded Oncogenes in Viral Carcinogenesis Using Laboratory Model Systems
A study testing HPV oncogenes in people with DNA Virus Infections, run by Heba Momen kamel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- DNA Virus Infections
- What is being tested?
- HPV oncogenes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2017to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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;
Read more
- 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.
Read the 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.
- Conditions
- DNA Virus Infections
- Being tested
- HPV oncogenes
- Medical subject headings
- DNA Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV oncogenesGenetic
PCR and oncogenes detection
| Study group | Role | What they receive |
|---|---|---|
| cases | Experimental | HPV detection HPV Genotyping HPV Oncogenes and oncoproteins Receives: Genetic: HPV oncogenes |
| control | Active comparator | HPV detection HPV Genotyping HPV Oncogenes and oncoproteins Receives: Genetic: HPV oncogenes |
What is being measured
The primary outcome is the main question the study is designed to answer.
carcinogenesis
developing cancer cervix
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start1 Sep 2017 (estimated)
- Primary completion28 Feb 2018 (estimated)
- Study completion28 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DNA Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heba Momen kamel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heba Momen kamel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188315
- Sponsor's protocol ID
- 17200086
- Status last verified
- Jun 2017
- First submitted
- 13 Jun 2017
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Small DNA Virus Encoded Oncogenes in Viral Carcinogenesis Using Laboratory Model Systems
- ClinicalTrials.gov ID
- NCT03188315
- Acronym / sponsor ID
- 17200086
- Conditions
- DNA Virus Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Heba Momen kamelUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 28 Feb 2018 (estimated)
- Study completion
- 28 Feb 2018 (estimated)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | Experimental | Genetic: HPV oncogenesHPV detection HPV Genotyping HPV Oncogenes and oncoproteins |
| control | Active comparator | Genetic: HPV oncogenesHPV detection HPV Genotyping HPV Oncogenes and oncoproteins |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV oncogenesPCR and oncogenes detection | Genetic | cases, control |
Primary outcome
carcinogenesis
Time frame: 6 months
developing cancer cervix
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing HPV oncogenes in people with DNA Virus Infections, run by Heba Momen kamel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
carcinogenesis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2017.