Evaluation of New Tissue Biomarkers for Cervical CancerNCT02238990
Biomarkerscreening in Cervical Cancer and Its Preinvasive Lesions
An observational study of Evaluation of New Tissue Biomarkers for Cervical Cancer, run by University of Luebeck at 1 site in Germany.
Trial summary
The following trial is a multicenter and prospective research trial of the colposcopy unit of luebeck university and the national research center in Borstel, Germany. The study is to identify and evaluate new biomarkers in human papilloma virus (HPV) associated malignancies and its preinvasive lesions of the cervix… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Evaluation of New Tissue Biomarkers for Cervical Cancer
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to 1 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The population is to be recruted from A. patients suffering from cervical cancer B. patients suffering from preinvasive cervical lesions
Who may be able to join
- Positive informed consent
- Patients with suspected preinvasive genital lesion
- Patients with confirmed genital lesion (both preinvasive and invasive)
- Contact via dept. of obs/gyn of luebeck university
- Complete set of data
Who cannot join
- Incomplete set of data
- Negative informed consent
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: Biomarkerscreening Via Transcriptome and Methylosome Analysis in Cervical Cancer and Its Preinvasive Lesions
The following trial is a multicenter and prospective research trial of the colposcopy unit of luebeck university and the national research center in Borstel, Germany.
The study is to identify and evaluate new biomarkers in human papilloma virus (HPV) associated malignancies and its preinvasive lesions of the cervix uteri. Fresh tissue samples being removed during conizations and/or hysterectomies are to be fixed in HOPE's solution and analyzed according to their transcriptomes and methylosome. The hereby found candidates are to be validated using immunohistochemistry and RT [real-time] -PCR [polymerase chain reaction].
The project is meant to be followed by continuous studies developing a new test describing the malignant potential of HPV associated genital lesions.
What is being measured
The primary outcome is the main question the study is designed to answer.
CIN III (cervical intraepithelial neoplasia) lesions
number of CIN III lesions
Measured: three years
cervical cancer
number of cervical cancer probes
Measured: three years
HPV
number and type of HPV infection of the analyzed probes
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startSep 2014
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
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 Evaluation of New Tissue Biomarkers for Cervical CancerStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Alexander Beyer, University of Luebeck
- Investigators
- Daniel Beyer, PD Dr., Principal investigator, University of LuebeckTorsten Goldmann, Prof. Dr., Principal investigator, Forschungszentrum Borstel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238990
- Sponsor's protocol ID
- UKSH-HL-14-099
- Other IDs
- UKSH-HL-14-099
- Status last verified
- May 2022
- First submitted
- 4 Sep 2014
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Apgar BS, Kittendorf AL, Bettcher CM, Wong J, Kaufman AJ. Update on ASCCP consensus guidelines for abnormal cervical screening tests and cervical histology. Am Fam Physician. 2009 Jul 15;80(2):147-55.
PubMed 19621855Gagne HM. Colposcopy of the vagina and vulva. Obstet Gynecol Clin North Am. 2008 Dec;35(4):659-69; x. doi: 10.1016/j.ogc.2008.10.002.
PubMed 19061824Massad 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 19550210
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkerscreening Via Transcriptome and Methylosome Analysis in Cervical Cancer and Its Preinvasive Lesions
- ClinicalTrials.gov ID
- NCT02238990
- Acronym / sponsor ID
- UKSH-HL-14-099
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 12 Sep 2014 (estimated)
- 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.
The following trial is a multicenter and prospective research trial of the colposcopy unit of luebeck university and the national research center in Borstel, Germany.
The study is to identify and evaluate new biomarkers in human papilloma virus (HPV) associated malignancies and its preinvasive lesions of the cervix uteri. Fresh tissue samples being removed during conizations and/or hysterectomies are to be fixed in HOPE's solution and analyzed according to their transcriptomes and methylosome. The hereby found candidates are to be validated using immunohistochemistry and RT [real-time] -PCR [polymerase chain reaction].
The project is meant to be followed by continuous studies developing a new test describing the malignant potential of HPV associated genital lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population is to be recruted from A. patients suffering from cervical cancer B. patients suffering from preinvasive cervical lesions
Key inclusion criteria (5 listed)
- Positive informed consent
- Patients with suspected preinvasive genital lesion
- Patients with confirmed genital lesion (both preinvasive and invasive)
- Contact via dept. of obs/gyn of luebeck university
- Complete set of data
Key exclusion criteria (2 listed)
- Incomplete set of data
- Negative informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CIN III (cervical intraepithelial neoplasia) lesions
Time frame: three years
number of CIN III lesions
cervical cancer
Time frame: three years
number of cervical cancer probes
HPV
Time frame: three years
number and type of HPV infection of the analyzed probes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Background: PubMed 19621855Apgar BS, Kittendorf AL, Bettcher CM, Wong J, Kaufman AJ. Update on ASCCP consensus guidelines for abnormal cervical screening tests and cervical histology. Am Fam Physician. 2009 Jul 15;80(2):147-55.
- Background: PubMed 19061824Gagne HM. Colposcopy of the vagina and vulva. Obstet Gynecol Clin North Am. 2008 Dec;35(4):659-69; x. doi: 10.1016/j.ogc.2008.10.002.
- 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.
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, PD Dr. principal investigator
University of Luebeck
Torsten Goldmann, Prof. Dr. principal investigator
Forschungszentrum Borstel
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 Evaluation of New Tissue Biomarkers for Cervical Cancer, 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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 31 May 2022. 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?
This study is still under way. Results are not available in the source record yet.
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?
CIN III (cervical intraepithelial neoplasia) lesions (time frame: three years). The study lists 3 primary outcomes in all. 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 NCT02238990, 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 31 May 2022.