Trial · NCT03196180
Topical Fluorouracil and Imiquimod in Treating Patients With High-Grade Cervical Intraepithelial Neoplasia
NCT03196180, Early phase 1, Completed, National Cancer Institute (NCI); results first posted 2022-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Topical Fluorouracil and Imiquimod in Treating Patients With High-Grade Cervical Intraepithelial Neoplasia. Trials, record NCT03196180. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03196180
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topical Fluorouracil and Imiquimod in Treating Patients With High-Grade Cervical Intraepithelial Neoplasia
- NCT number
- NCT03196180
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 13 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Cervical Intraepithelial Neoplasia Grade 2/3, Cervical Squamous Cell Carcinoma In Situ, Cervical Squamous Intraepithelial Neoplasia 2, High Grade Cervical Intraepithelial Neoplasia
- Interventions
- Imiquimod, Topical Fluorouracil
- First posted
- 2017-06-22
- Last updated
- 2025-04-08
- Results first posted
- 2022-02-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility of Intravaginal Use 5-FU and Imiquimod on Alternating Weeks in Women With Biopsy Confirmed High Grade Cervical Squamous Intraepithelial Lesions. | Up to 22 weeks | Feasibility is evaluated based on safety and tolerability of the study intervention. For safety, the study assessed the number of participants experiencing the specified adverse events defined as Grade 2 or greater toxicity (or Grade 1 toxicity of any genital lesion (blisters, ulcerations, or pustules)) that is possibly, probably, or definitely related and lasts for more than 5 days. For tolerability, the study assessed the number of participants who were not able to apply at least 50% of the treatment due to the specified adverse events. |
| Secondary | Response to Intravaginal 5-FU and Imiquimod Defined as Histologic Regression and Clearance of High-risk Human Papilloma Virus (HR-HPV) | At end of study visit (4-6 weeks after the last agent application) | The response will be reported along with their 95% confidence intervals. Response is defined as histologic regression from high-grade lesions to low-grade- or no lesions and clearance of HR-HPV detection between baseline and end of study. |
| Secondary | Type Specific Human Papillomavirus (HPV) Clearance | At end of study visit (4-6 weeks after the last agent application) | The type-specific HR-HPV clearance will be reported along with their 95% confidence intervals. |
| Secondary | Change in Expression of Biomarkers of Local Immune Activation (Cytokines) After Treatment With Self-administered Intravaginal Topical Fluorouracil and Imiquimod | Baseline to up to end of study visit (4-6 weeks after last agent application) | For each biomarker, the mean change of log transformed data and the associated standard deviation will be reported. Will measure the innate (IFN-alpha2), immune mediating (IFN-gamma, IL-10, IL-12), and pro-inflammatory (IL-1alpha, -1beta, -6, -8, MIP-1alpha, TNF) cytokine. |
| Secondary | Change in Expression of Biomarkers of Local Immune Activation (Toll Like Receptors (TLRs)) After Treatment With Self-administered Intravaginal Topical Fluorouracil and Imiquimod | Baseline to up to end of study visit (4-6 weeks after last agent application) | For each biomarker, the mean change of log transformed data and the associated standard deviation will be reported. TLR messenger ribonucleic acid expression is normalized by the housekeeping genes and does not have a unit of measure. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Feasibility of Intravaginal Use 5-FU and Imiquimod on Alternating Weeks in Women With Biopsy Confirmed High Grade Cervical Squamous Intraepithelial Lesions. | Up to 22 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Response to Intravaginal 5-FU and Imiquimod Defined as Histologic Regression and Clearance of High-risk Human Papilloma Virus (HR-HPV) | At end of study visit (4-6 weeks after the last agent application) | Participants who were HR-HPV negative at baseline were excluded from the analysis | percentage of participants | NUMBER |
| SECONDARY | Type Specific Human Papillomavirus (HPV) Clearance | At end of study visit (4-6 weeks after the last agent application) | Participants positive for a given HPV genotype at baseline were assessed for the clearance of this genotype at the end of study. | percentage of participants | NUMBER |
| SECONDARY | Change in Expression of Biomarkers of Local Immune Activation (Cytokines) After Treatment With Self-administered Intravaginal Topical Fluorouracil and Imiquimod | Baseline to up to end of study visit (4-6 weeks after last agent application) | Participants with data at both baseline and end of study for a given biomarker were included in the analysis. | log pg/ml | MEAN |
| SECONDARY | Change in Expression of Biomarkers of Local Immune Activation (Toll Like Receptors (TLRs)) After Treatment With Self-administered Intravaginal Topical Fluorouracil and Imiquimod | Baseline to up to end of study visit (4-6 weeks after last agent application) | Participants with data at both baseline and end of study for a given biomarker were included in the analysis. | gene expression level | MEAN |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Feasibility of Intravaginal Use 5-FU and Imiquimod on Alternating Weeks in Women With Biopsy Confirmed High Grade Cervical Squamous Intraepithelial Lesions. | Treatment (Topical Fluorouracil, Imiquimod) | Safety | 4 | Participants | |
| Feasibility of Intravaginal Use 5-FU and Imiquimod on Alternating Weeks in Women With Biopsy Confirmed High Grade Cervical Squamous Intraepithelial Lesions. | Treatment (Topical Fluorouracil, Imiquimod) | Tolerability | 1 | Participants | |
| Response to Intravaginal 5-FU and Imiquimod Defined as Histologic Regression and Clearance of High-risk Human Papilloma Virus (HR-HPV) | Treatment (Topical Fluorouracil, Imiquimod) | 40 | 95% Confidence Interval 12 to 74 | percentage of participants | |
| Type Specific Human Papillomavirus (HPV) Clearance | Treatment (Topical Fluorouracil, Imiquimod) | HPV16 | 75 | 95% Confidence Interval 19 to 99 | percentage of participants |
| Type Specific Human Papillomavirus (HPV) Clearance | Treatment (Topical Fluorouracil, Imiquimod) | HPV31 | 50 | 95% Confidence Interval 1 to 99 | percentage of participants |
| Type Specific Human Papillomavirus (HPV) Clearance | Treatment (Topical Fluorouracil, Imiquimod) | HPV35 | 100 | 95% Confidence Interval 3 to 100 | percentage of participants |
| Type Specific Human Papillomavirus (HPV) Clearance | Treatment (Topical Fluorouracil, Imiquimod) | HPV39 | 0 | 95% Confidence Interval 0 to 98 | percentage of participants |
| Type Specific Human Papillomavirus (HPV) Clearance | Treatment (Topical Fluorouracil, Imiquimod) | HPV51 | 0 | 95% Confidence Interval 0 to 84 | percentage of participants |
| Type Specific Human Papillomavirus (HPV) Clearance | Treatment (Topical Fluorouracil, Imiquimod) | HPV52 | 75 | 95% Confidence Interval 19 to 99 | percentage of participants |
| Type Specific Human Papillomavirus (HPV) Clearance | Treatment (Topical Fluorouracil, Imiquimod) | HPV56 | 0 | 95% Confidence Interval 0 to 98 | percentage of participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Topical Fluorouracil, Imiquimod) | 13 | |
| Overall Study | COMPLETED | Treatment (Topical Fluorouracil, Imiquimod) | 11 | |
| Overall Study | NOT COMPLETED | Treatment (Topical Fluorouracil, Imiquimod) | 2 |
Source ClinicalTrials.gov
Adverse events30
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 | Abdominal pain | Gastrointestinal disorders | Treatment (Topical Fluorouracil, Imiquimod) | 1 | 13 | |
| other | Pain - Lower abdominal | Gastrointestinal disorders | Treatment (Topical Fluorouracil, Imiquimod) | 2 | 13 | |
| other | Fever | General disorders | Treatment (Topical Fluorouracil, Imiquimod) | 1 | 13 | |
| other | Flu like symptoms | General disorders | Treatment (Topical Fluorouracil, Imiquimod) | 1 | 13 | |
| other | Other | General disorders | Treatment (Topical Fluorouracil, Imiquimod) | 2 | 13 | |
| other | Bacterial vaginosis | Infections and infestations | Treatment (Topical Fluorouracil, Imiquimod) | 1 | 13 | |
| other | Candida | Infections and infestations | Treatment (Topical Fluorouracil, Imiquimod) | 1 | 13 | |
| other | Upper respiratory infection | Infections and infestations | Treatment (Topical Fluorouracil, Imiquimod) | 5 | 13 | |
| other | Weight gain | Investigations | Treatment (Topical Fluorouracil, Imiquimod) | 3 | 13 | |
| other | Weight loss | Investigations | Treatment (Topical Fluorouracil, Imiquimod) | 2 | 13 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Topical Fluorouracil, Imiquimod) | 0 | 13 |
| Total, other adverse events | Treatment (Topical Fluorouracil, Imiquimod) | 13 | 13 |
| Total, serious adverse events | Treatment (Topical Fluorouracil, Imiquimod) | 0 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA023074 | University of Arizona Cancer Center - Cancer Center Support Grant | THEODORESCU, DAN | UNIVERSITY OF ARIZONA | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT03196180
GET https://conductscience.org/api/trials/v1/NCT03196180/results?page=2