Cervix LesionNCT04274465
Application of Plasma Circulating HPV DNA Testing to Management of Cervical Intraepithelial Neoplasia
An observational study of Cervix Lesion and Cervical Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to see if circulating HPV DNA (cHPVDNA) can be used as a noninvasive biomarker for cervical intraepithelial neoplasia (CIN) 2-3 in hopes of reducing procedures and costs for patients, as well as personalize their treatment plan. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervix Lesion, Cervical Cancer
- What is being tested?
- digital PCR (dPCR) assay
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2020to 15 Jul 2024
- 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 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women ≥ 18 years old who are presenting to UNC Gynecology clinics with or without dysplasia and may or may not need colposcopy, biopsy, or lesion excisions.
Who may be able to join
- No history of previously treated cervical cancer
- Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee
Who cannot join
- Women who are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Tuvara Jenene King
Chapel Hill, North Carolina, 27599
About this study
Official title: Application of Plasma Circulating Human Papillomavirus (HPV) DNA Testing to Management of Cervical Intraepithelial Neoplasia
The purpose of this study is to see if circulating HPV DNA (cHPVDNA) can be used as a noninvasive biomarker for cervical intraepithelial neoplasia (CIN) 2-3 in hopes of reducing procedures and costs for patients, as well as personalize their treatment plan.
Read the detailed description
cHPVDNA is detectable in plasma of patients with invasive disease and CIN 1-3, and with the development of a highly sensitive and specific droplet digital Polymerase Chain Reaction (PCR) assay, it is hoped to be identified more prevalently and thus can improve risk stratification and help produce personalized treatment decisions and may be more cost-efficient. Plasma samples and cervical swabs will be collected from patients in University of North Carolina (UNC) Gynecology clinics, and some patients will also provide a urine sample. Those receiving biopsies or colposcopies and will come back to clinic 2-4 weeks post-excision for collection of another blood specimen. Using plasma samples and pathology results, we will characterize the relationship between plasma cHPVDNA levels and 1) CIN 1 versus CIN 2-3 pathology 2) CIN 2-3 pre-excision and 2-4 weeks post-excision. We will accrue three cohorts of 25, 30, 30 patients corresponding to 1) Control 2) CIN 1 3) CIN 2-3. The control cohort will establish background signal in the assay. We will compare the proportion of detectable cHPVDNA levels between CIN 1 and CIN 2-3 cohorts using Fisher's exact test with 80% power, significance level of 10%. Paired t-test will be used to compare pre- and post-excision cHPVDNA levels.
- Conditions
- Cervix Lesion, Cervical Cancer
- Being tested
- digital PCR (dPCR) assay
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital PCR (dPCR) assayDiagnostic test
It is a highly sensitive and specific droplet digital PCR assay for absolute quantification of circulating tumor HPV DNA for the most prevalent HPV types that will determine if a woman has cHPVDNA
| Study group | Role | What they receive |
|---|---|---|
| Control | Negative high risk (HR)-HPV, cytology co-test Receives: Diagnostic Test: digital PCR (dPCR) assay | |
| CIN 1 | Biopsy with low grade dysplasia Receives: Diagnostic Test: digital PCR (dPCR) assay | |
| CIN 2-3 | Biopsy with high grade dysplasia Receives: Diagnostic Test: digital PCR (dPCR) assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between plasma cHPVDNA levels and presence of CIN 2-3 histopathology
We will quantify cHPVDNA levels in blood plasma from patients with normal screening, CIN 1, and CIN 2-3 cervical disease prior to treatment.
Measured: Baseline
Secondary outcomes (1)
Changes in cHPVDNA levels following excisional therapy for CIN 2-3 cervical disease.
For patients who undergo excisional therapy, we will collect bio-specimens and quantify cHPVDNA levels in plasma during their post-procedure visit.
Measured: 2-4 weeks post-excision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start26 Feb 2020
- Primary completion26 Jun 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix LesionStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shivani Sud, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274465
- Sponsor's protocol ID
- LCCC 1928
- Status last verified
- Nov 2024
- First submitted
- 14 Feb 2020
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Plasma Circulating Human Papillomavirus (HPV) DNA Testing to Management of Cervical Intraepithelial Neoplasia
- ClinicalTrials.gov ID
- NCT04274465
- Acronym / sponsor ID
- LCCC 1928
- Conditions
- Cervix Lesion, Cervical Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 18 Feb 2020 (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.
The purpose of this study is to see if circulating HPV DNA (cHPVDNA) can be used as a noninvasive biomarker for cervical intraepithelial neoplasia (CIN) 2-3 in hopes of reducing procedures and costs for patients, as well as personalize their treatment plan.
Detailed description
cHPVDNA is detectable in plasma of patients with invasive disease and CIN 1-3, and with the development of a highly sensitive and specific droplet digital Polymerase Chain Reaction (PCR) assay, it is hoped to be identified more prevalently and thus can improve risk stratification and help produce personalized treatment decisions and may be more cost-efficient. Plasma samples and cervical swabs will be collected from patients in University of North Carolina (UNC) Gynecology clinics, and some patients will also provide a urine sample. Those receiving biopsies or colposcopies and will come back to clinic 2-4 weeks post-excision for collection of another blood specimen. Using plasma samples and pathology results, we will characterize the relationship between plasma cHPVDNA levels and 1) CIN 1 versus CIN 2-3 pathology 2) CIN 2-3 pre-excision and 2-4 weeks post-excision. We will accrue three cohorts of 25, 30, 30 patients corresponding to 1) Control 2) CIN 1 3) CIN 2-3. The control cohort will establish background signal in the assay. We will compare the proportion of detectable cHPVDNA levels between CIN 1 and CIN 2-3 cohorts using Fisher's exact test with 80% power, significance level of 10%. Paired t-test will be used to compare pre- and post-excision cHPVDNA levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: digital PCR (dPCR) assayNegative high risk (HR)-HPV, cytology co-test |
| CIN 1 | – | Diagnostic Test: digital PCR (dPCR) assayBiopsy with low grade dysplasia |
| CIN 2-3 | – | Diagnostic Test: digital PCR (dPCR) assayBiopsy with high grade dysplasia |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women ≥ 18 years old who are presenting to UNC Gynecology clinics with or without dysplasia and may or may not need colposcopy, biopsy, or lesion excisions.
Key inclusion criteria (2 listed)
- No history of previously treated cervical cancer
- Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee
Key exclusion criteria (1 listed)
- Women who are pregnant or nursing
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 |
|---|---|---|
| digital PCR (dPCR) assayIt is a highly sensitive and specific droplet digital PCR assay for absolute quantification of circulating tumor HPV DNA for the most prevalent HPV types that will determine if a woman has cHPVDNA | Diagnostic test | CIN 1, CIN 2-3, Control |
Primary outcome
Relationship between plasma cHPVDNA levels and presence of CIN 2-3 histopathology
Time frame: Baseline
We will quantify cHPVDNA levels in blood plasma from patients with normal screening, CIN 1, and CIN 2-3 cervical disease prior to treatment.
1 secondary outcome
Changes in cHPVDNA levels following excisional therapy for CIN 2-3 cervical disease.
Time frame: 2-4 weeks post-excision
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 14 Nov 2024.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
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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.
Shivani Sud, MD principal investigator
University of North Carolina, Chapel Hill
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 Cervix Lesion and Cervical Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
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 2 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 14 Nov 2024. 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 United States. 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?
Relationship between plasma cHPVDNA levels and presence of CIN 2-3 histopathology (time frame: Baseline). 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 14 Nov 2024.