HPVNCT03082950
HPV Infections, Cancer of the Vulva and Therapeutical Success
An observational study of HPV and Human Papilloma Virus, run by University of Luebeck at 1 site in Germany.
Trial summary
HPV infections may be responsible for different types of cancer in females. Primary Goal of the study was to identify the prevalence of an hpv affiliation in retrospective-prospective analysed cohort of patients who suffer from vulvar cancer and their preinvasive lesions. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- HPV, Human Papilloma Virus
- What is being tested?
- polymerase chain reaction
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to May 2018
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: pts. who suffer from vulvar cancer and their preinvasive lesions who were treated in luebeck University medical Center over a 15 year period
Who may be able to join
- pts. who suffer from vulvar cancer and their preinvasive lesions
- positive informed consent
- complete set of data
- Treatment in luebeck university
Who cannot join
- opposite of above
Trial locations and contacts
1 site in 1 country.
Germany1 site
Luebeck University, Department for obstetrics and gynecology
Lübeck, Schleswig-Holstein, D-23538
About this study
Official title: Influence of Hpv Infections on Therapeutical Outcome of Patients Suffering From Vulvar Cancer and Ist Preinvasive Lesions
HPV infections may be responsible for different types of cancer in females. Primary Goal of the study was to identify the prevalence of an hpv affiliation in retrospective-prospective analysed cohort of patients who suffer from vulvar cancer and their preinvasive lesions.
Read the detailed description
HPV infections may be responsible for different types of cancer in females. Primary Goal of the study was to identify the prevalence of an hpv affiliation in retrospective-prospective analysed cohort of patients who suffer from vulvar cancer and their preinvasive lesions.
After having retrospectively identified patients with vulvar cancer incl. their preinvasive lesions in the clinical registry the hpv status of the samples is prospectively analyzed using a new multiplex pcr Array. Two Groups are build: patients with hpv associated vulvar cancer and patients with non-hpv associated vulvar cancer.
Then, the rate of patients who respond to radiotherapy within the Groups is analyzed by building Kaplan meier plots according to the patients survival and recurrence rate.
- Conditions
- HPV, Human Papilloma Virus
- Being tested
- polymerase chain reaction
- Keywords
- hpv prevalence, recurrence rate, survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polymerase chain reactionDiagnostic test
Also called EUROARRAY
PCR is performed with all patients. The result (hpv positive or negative) will define the patiens Group Affiliation.
| Study group | Role | What they receive |
|---|---|---|
| 1 | human papilloma Virus (hpv) associated vulvar cancer incl. preinvasive lesions Receives: Diagnostic Test: polymerase chain reaction | |
| 2 | non-human papilloma Virus (hpv) associated vulvar cancer incl. preinvasive lesions Receives: Diagnostic Test: polymerase chain reaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of hpv infections among pations suffering from vulvar cancer and preinvasive lesions
Measured: 15yrs
Secondary outcomes (1)
disease free survival among the groups
Measured: 15yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study startOct 2015
- Primary completionDec 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HPVStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Collaborators
- EUROIMMUN Medizinische Labordiagnostika AG
- Responsible party
- Principal investigator, Daniel Alexander Beyer, University of Luebeck
- Investigators
- Daniel Beyer, MD, Principal investigator, Westpfalz-Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082950
- Sponsor's protocol ID
- HL-15-220
- Status last verified
- May 2018
- First submitted
- 12 Mar 2017
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Massad LS, Jeronimo J, Katki HA, Schiffman M; National Institutes of Health/American Society for Colposcopy and Cervical Pathology Research Group. The accuracy of colposcopic grading for detection of high-grade cervical intraepithelial neoplasia. J Low Genit Tract Dis. 2009 Jul;13(3):137-44. doi: 10.1097/LGT.0b013e31819308d4.
PubMed 19550210Sri T, Merideth MA, Pulanic TK, Childs R, Stratton P. Human papillomavirus reactivation following treatment of genital graft-versus-host disease. Transpl Infect Dis. 2013 Aug;15(4):E148-51. doi: 10.1111/tid.12098. Epub 2013 May 28.
PubMed 23710698Nocon M, Mittendorf T, Roll S, Greiner W, Willich SN, von der Schulenburg JM. Review on the medical and health economic evidence for an inclusion of colposcopy in primary screening programs for cervical cancer. GMS Health Technol Assess. 2007 Aug 10;3:Doc07.
PubMed 21289941
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Hpv Infections on Therapeutical Outcome of Patients Suffering From Vulvar Cancer and Ist Preinvasive Lesions
- ClinicalTrials.gov ID
- NCT03082950
- Acronym / sponsor ID
- HL-15-220
- Conditions
- HPV, Human Papilloma Virus
- Keywords
- hpv prevalence, recurrence rate, survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Collaborators
- EUROIMMUN Medizinische Labordiagnostika AG
- Study start
- Oct 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 17 Mar 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.
HPV infections may be responsible for different types of cancer in females. Primary Goal of the study was to identify the prevalence of an hpv affiliation in retrospective-prospective analysed cohort of patients who suffer from vulvar cancer and their preinvasive lesions.
Detailed description
HPV infections may be responsible for different types of cancer in females. Primary Goal of the study was to identify the prevalence of an hpv affiliation in retrospective-prospective analysed cohort of patients who suffer from vulvar cancer and their preinvasive lesions.
After having retrospectively identified patients with vulvar cancer incl. their preinvasive lesions in the clinical registry the hpv status of the samples is prospectively analyzed using a new multiplex pcr Array. Two Groups are build: patients with hpv associated vulvar cancer and patients with non-hpv associated vulvar cancer.
Then, the rate of patients who respond to radiotherapy within the Groups is analyzed by building Kaplan meier plots according to the patients survival and recurrence rate.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: polymerase chain reactionhuman papilloma Virus (hpv) associated vulvar cancer incl. preinvasive lesions |
| 2 | – | Diagnostic Test: polymerase chain reactionnon-human papilloma Virus (hpv) associated vulvar cancer incl. preinvasive lesions |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pts. who suffer from vulvar cancer and their preinvasive lesions who were treated in luebeck University medical Center over a 15 year period
Key inclusion criteria (4 listed)
- pts. who suffer from vulvar cancer and their preinvasive lesions
- positive informed consent
- complete set of data
- Treatment in luebeck university
Key exclusion criteria (1 listed)
- opposite of above
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 |
|---|---|---|
| polymerase chain reactionAlso: EUROARRAYPCR is performed with all patients. The result (hpv positive or negative) will define the patiens Group Affiliation. | Diagnostic test | 1, 2 |
Primary outcome
prevalence of hpv infections among pations suffering from vulvar cancer and preinvasive lesions
Time frame: 15yrs
1 secondary outcome
disease free survival among the groups
Time frame: 15yrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Background: PubMed 19550210Massad LS, Jeronimo J, Katki HA, Schiffman M; National Institutes of Health/American Society for Colposcopy and Cervical Pathology Research Group. The accuracy of colposcopic grading for detection of high-grade cervical intraepithelial neoplasia. J Low Genit Tract Dis. 2009 Jul;13(3):137-44. doi: 10.1097/LGT.0b013e31819308d4.
- Background: PubMed 23710698Sri T, Merideth MA, Pulanic TK, Childs R, Stratton P. Human papillomavirus reactivation following treatment of genital graft-versus-host disease. Transpl Infect Dis. 2013 Aug;15(4):E148-51. doi: 10.1111/tid.12098. Epub 2013 May 28.
- Background: PubMed 21289941Nocon M, Mittendorf T, Roll S, Greiner W, Willich SN, von der Schulenburg JM. Review on the medical and health economic evidence for an inclusion of colposcopy in primary screening programs for cervical cancer. GMS Health Technol Assess. 2007 Aug 10;3:Doc07.
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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.
Daniel Beyer, MD principal investigator
Westpfalz-Klinikum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV and Human Papilloma Virus, run by University of Luebeck at 1 site in Germany.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
prevalence of hpv infections among pations suffering from vulvar cancer and preinvasive lesions (time frame: 15yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03082950, which also lists 3 linked publications.
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 3 May 2018.