Trial · NCT02864147
Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3)
NCT02864147, Phase 2, Completed, Yale University; results first posted 2024-05-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3). Trials, record NCT02864147. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02864147
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3)
- NCT number
- NCT02864147
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 134 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Cervical Intraepithelial Neoplasia, Cervical Dysplasia
- Interventions
- 9-valent HPV vaccine, Imiquimod
- First posted
- 2016-08-11
- Last updated
- 2024-05-02
- Results first posted
- 2024-05-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Objective Response | Between weeks 20 and 24 (approximately week 22) | The major parameters of objective response to be assessed include treatment efficacy defined as histologic regression of cervical dysplasia to CIN 1 or less after the end of imiquimod treatment, HPV clearance and treatment tolerance. Objective response will be categorized as 'yes' or 'no' and included in the evaluations are the following criteria: * Histologic regression (HR): Histologic regression of all index lesions to CIN 1 or less after end of imiquimod treatment period. * Histologic remission (HM): Complete regression of cervical dysplasia at all index biopsy sites after end of imiquimod treatment period. * Persistent Disease (PR): One or more index lesions persists with CIN 2,3 high grade dysplasia or new lesions are identified colposcopically and histologically confirmed to be CIN 2,3. * Progressive Disease (PD): Worsening histology of an index lesion. |
| Secondary | Incidence of HPV Clearance | Between weeks 20 and 24 (approximately week 22) | HPV Clearance will be categorized as 'yes' or 'no' and the evaluations are the following criteria: HPV clearance will be measured by both the Roche cobas HPV Test utilized by pathology concomitant with the pap test at final study visit which assesses for presence of 14 high risk HPV types as well as HPV 16/18 genotyping performed by Santin Lab. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Objective Response | Between weeks 20 and 24 (approximately week 22) | Complete case analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of HPV Clearance | Between weeks 20 and 24 (approximately week 22) | Complete case analysis- 2 participants in imiquimod + 9-valent HPV vaccine were not assessed at follow up. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Objective Response | Imiquimod + 9-valent HPV Vaccine | Histologic regression (HR) | 32 | Participants | |
| Incidence of Objective Response | Imiquimod Only | Histologic regression (HR) | 36 | Participants | |
| Incidence of Objective Response | Observation Only (Control) | Histologic regression (HR) | 30 | Participants | |
| Incidence of Objective Response | Imiquimod + 9-valent HPV Vaccine | Histologic remission (HM) | 0 | Participants | |
| Incidence of Objective Response | Imiquimod Only | Histologic remission (HM) | 0 | Participants | |
| Incidence of Objective Response | Observation Only (Control) | Histologic remission (HM) | 0 | Participants | |
| Incidence of Objective Response | Imiquimod + 9-valent HPV Vaccine | Persistent Disease (PR) | 6 | Participants | |
| Incidence of Objective Response | Imiquimod Only | Persistent Disease (PR) | 2 | Participants | |
| Incidence of Objective Response | Observation Only (Control) | Persistent Disease (PR) | 8 | Participants | |
| Incidence of Objective Response | Imiquimod + 9-valent HPV Vaccine | Progressive Disease (PD) | 0 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Observation Only (Control) | 45 | |
| Overall Study | STARTED | Imiquimod Only | 45 | |
| Overall Study | STARTED | Imiquimod + 9-valent HPV Vaccine | 43 | |
| Overall Study | Completed Treatment | Observation Only (Control) | 45 | |
| Overall Study | Completed Treatment | Imiquimod Only | 45 | |
| Overall Study | Completed Treatment | Imiquimod + 9-valent HPV Vaccine | 43 | |
| Overall Study | Placed On Follow Up | Observation Only (Control) | 29 | |
| Overall Study | Placed On Follow Up | Imiquimod Only | 35 | |
| Overall Study | Placed On Follow Up | Imiquimod + 9-valent HPV Vaccine | 28 | |
| Overall Study | COMPLETED | Observation Only (Control) | 38 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events144
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Observation Only (Control) | 1 | 45 | 1 |
| other | Palpitations | Cardiac disorders | Imiquimod Only | 0 | 45 | 0 |
| other | Palpitations | Cardiac disorders | Imiquimod + 9-valent HPV Vaccine | 0 | 43 | 0 |
| other | Congenital, familial and genetic disorders - Other, specify | Congenital, familial and genetic disorders | Observation Only (Control) | 0 | 45 | 0 |
| other | Congenital, familial and genetic disorders - Other, specify | Congenital, familial and genetic disorders | Imiquimod Only | 0 | 45 | 0 |
| other | Congenital, familial and genetic disorders - Other, specify | Congenital, familial and genetic disorders | Imiquimod + 9-valent HPV Vaccine | 1 | 43 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Observation Only (Control) | 0 | 45 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Imiquimod Only | 0 | 45 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Imiquimod + 9-valent HPV Vaccine | 1 | 43 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Observation Only (Control) | 0 | 45 | 0 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Observation Only (Control) | 0 | 45 |
| Total, all-cause mortality | Imiquimod Only | 0 | 45 |
| Total, all-cause mortality | Imiquimod + 9-valent HPV Vaccine | 0 | 43 |
| Total, other adverse events | Observation Only (Control) | 5 | 45 |
| Total, other adverse events | Imiquimod Only | 38 | 45 |
| Total, other adverse events | Imiquimod + 9-valent HPV Vaccine | 36 | 43 |
| Total, serious adverse events | Observation Only (Control) | 0 | 45 |
| Total, serious adverse events | Imiquimod Only | 0 | 45 |
| Total, serious adverse events | Imiquimod + 9-valent HPV Vaccine | 1 | 43 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02864147
GET https://conductscience.org/api/trials/v1/NCT02864147/events?page=2