Trial Outcomes & Findings for Anal Human Papillomavirus in Inflammatory Bowel Disease Study (NCT NCT01364896)
NCT ID: NCT01364896
Last Updated: 2019-05-21
Results Overview
Anal (and vaginal for female participants) HPV PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58) using the SYBR-Green-based real-time PCR assay with a reverse line blot assay for genotyping of HPV in the positive samples and Taqman probe-based real-time PCR assays for quantification of individual HPV subtypes
Recruitment status
COMPLETED
Target enrollment
46 participants
Primary outcome timeframe
Baseline and 6 to 12 months
Results posted on
2019-05-21
Participant Flow
Participant milestones
| Measure |
Inflammatory Bowel Disease, Immunosuppressive Agent
Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent
Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:
1. Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)
2. High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria
3. Anal cytology testing
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anal Human Papillomavirus in Inflammatory Bowel Disease Study
Baseline characteristics by cohort
| Measure |
Inflammatory Bowel Disease, Immunosuppressive Agent
n=46 Participants
Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent
Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:
1. Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)
2. High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria
3. Anal cytology testing
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
|
Number of participants with Crohn's Disease
|
31 participants
n=5 Participants
|
|
Number of participants with Ulcerative Colitis
|
14 participants
n=5 Participants
|
|
Number of participants with Indeterminate Colitis
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 to 12 monthsAnal (and vaginal for female participants) HPV PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58) using the SYBR-Green-based real-time PCR assay with a reverse line blot assay for genotyping of HPV in the positive samples and Taqman probe-based real-time PCR assays for quantification of individual HPV subtypes
Outcome measures
| Measure |
Inflammatory Bowel Disease, Immunosuppressive Agent
n=46 Participants
Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent
Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:
1. Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)
2. High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria
3. Anal cytology testing
|
|---|---|
|
Number of Participants With Anal HPV of Any Type, Single Type, and Multiple Types
Number of Participants with Anal HPV of Any Type
|
41 participants
|
|
Number of Participants With Anal HPV of Any Type, Single Type, and Multiple Types
Number of Participants with Single Types
|
16 participants
|
|
Number of Participants With Anal HPV of Any Type, Single Type, and Multiple Types
Number of Participants with Multiple Types
|
25 participants
|
PRIMARY outcome
Timeframe: Baseline and 6 to 12 monthsOutcome measures
| Measure |
Inflammatory Bowel Disease, Immunosuppressive Agent
n=41 Participants
Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent
Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:
1. Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)
2. High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria
3. Anal cytology testing
|
|---|---|
|
Percent of Participants With HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and/or 58
Percent of Participants with HPV type 16
|
65.2 percentage of participants
|
|
Percent of Participants With HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and/or 58
Percent of Participants with HPV type 18
|
2.2 percentage of participants
|
|
Percent of Participants With HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and/or 58
Percent of Participants with HPV type 31
|
2.2 percentage of participants
|
|
Percent of Participants With HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and/or 58
Percent of Participants with HPV type 33
|
0 percentage of participants
|
|
Percent of Participants With HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and/or 58
Percent of Participants with HPV type 45
|
23.9 percentage of participants
|
|
Percent of Participants With HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and/or 58
Percent of Participants with HPV type 52
|
0 percentage of participants
|
|
Percent of Participants With HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and/or 58
Percent of Participants with HPV type 58
|
2.2 percentage of participants
|
|
Percent of Participants With HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and/or 58
Percent of Females with Vaginal HPV
|
90.5 percentage of participants
|
|
Percent of Participants With HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and/or 58
Percent of Participants with HPV type 6
|
6.6 percentage of participants
|
|
Percent of Participants With HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and/or 58
Percent of Participants with HPV type 11
|
23.9 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline and 6 to 12 monthsHigh-resolution anoscopy with anal cytology testing
Outcome measures
| Measure |
Inflammatory Bowel Disease, Immunosuppressive Agent
n=46 Participants
Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent
Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:
1. Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)
2. High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria
3. Anal cytology testing
|
|---|---|
|
Number of Participants With Abnormal Anal Cytology (ASC-US, ASC-H, LSIL, HSIL, Cancer)
Number of Participants with Abnormal Anal Cytology
|
21 participants
|
|
Number of Participants With Abnormal Anal Cytology (ASC-US, ASC-H, LSIL, HSIL, Cancer)
Number of Participants with Anal Dysplasia
|
28 participants
|
|
Number of Participants With Abnormal Anal Cytology (ASC-US, ASC-H, LSIL, HSIL, Cancer)
Number of Participants with HSIL
|
4 participants
|
|
Number of Participants With Abnormal Anal Cytology (ASC-US, ASC-H, LSIL, HSIL, Cancer)
Number of Participants with LSIL
|
24 participants
|
PRIMARY outcome
Timeframe: Baseline and 6 to 12 monthsHigh resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria
Outcome measures
| Measure |
Inflammatory Bowel Disease, Immunosuppressive Agent
n=46 Participants
Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent
Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:
1. Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)
2. High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria
3. Anal cytology testing
|
|---|---|
|
Number of Participants Who Had One or More Anal Biopsies
|
33 participants
|
PRIMARY outcome
Timeframe: Baseline and 6 to 12 monthsHigh resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria
Outcome measures
| Measure |
Inflammatory Bowel Disease, Immunosuppressive Agent
n=46 Participants
Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent
Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:
1. Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)
2. High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria
3. Anal cytology testing
|
|---|---|
|
Number of Participants With High-grade Anal Dysplasia Lesions
|
28 participants
|
Adverse Events
Inflammatory Bowel Disease, Immunosuppressive Agent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place