Trial · NCT03095703
Sirolimus and Familial Adenomatous Polyposis (FAP)
NCT03095703, Phase 2, Completed, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); results first posted 2024-10-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sirolimus and Familial Adenomatous Polyposis (FAP). Trials, record NCT03095703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03095703
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sirolimus and Familial Adenomatous Polyposis (FAP)
- NCT number
- NCT03095703
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Conditions
- Adenomatous Polyposis Coli
- Interventions
- Sirolimus
- First posted
- 2017-03-30
- Last updated
- 2024-10-24
- Results first posted
- 2024-10-24
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Marked Polyp Size | 6 Months | Effect of sirolimus on the size of 5 marked polyps per patient based on video observations. |
| Primary | Median Number of Treatment-Related Adverse Events Per Participant | 6 Months | Summary analysis of adverse events, clinical laboratory abnormalities and regular physical examination. |
| Secondary | Median Difference in Number of Intestinal Polyps | 6 Months | Number of intestinal polyps was determined by two independent reviewers, blinded for the order of videos (before and after treatment). The median difference comparing baseline en after 6 months of treatment was reported. |
| Secondary | Global Polyp Burden | 6 Months | The global polyp burden is estimated by the endoscopist and two independent reviewers. The second video in the pair could take the value of -2 (much better), -1 (better), 0 (same), 1 (worse) or 2 (much worse) relative to the first video. Mean scores are calculated for each subject and averaged for the three reviewers. If the assessment of the reviewers differs by more than 1 point from the assessment of the endoscopist, consensus is needed. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Marked Polyp Size | 6 Months | Size of marked polyps | NUMBER | |
| PRIMARY | Median Number of Treatment-Related Adverse Events Per Participant | 6 Months | Number of Adverse Events | MEDIAN | |
| SECONDARY | Median Difference in Number of Intestinal Polyps | 6 Months | Median number of polyps | MEDIAN | |
| SECONDARY | Global Polyp Burden | 6 Months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Marked Polyp Size | Sirolimus | Decrease in marked polyp size | 16 | Size of marked polyps | |
| Change in Marked Polyp Size | Sirolimus | Same marked polyp size | 4 | Size of marked polyps | |
| Change in Marked Polyp Size | Sirolimus | Increase in marked polyp size | 0 | Size of marked polyps | |
| Median Number of Treatment-Related Adverse Events Per Participant | Sirolimus | 10 | Full Range 4 to 16 | Number of Adverse Events | |
| Median Difference in Number of Intestinal Polyps | Sirolimus | 25.75 | Full Range 6.5 to 50 | Median number of polyps | |
| Global Polyp Burden | Sirolimus | Much better | 0 | Participants | |
| Global Polyp Burden | Sirolimus | Better | 3 | Participants | |
| Global Polyp Burden | Sirolimus | Same | 1 | Participants | |
| Global Polyp Burden | Sirolimus | Worse | 0 | Participants | |
| Global Polyp Burden | Sirolimus | Much worse | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sirolimus | 4 | |
| Overall Study | COMPLETED | Sirolimus | 3 | |
| Overall Study | NOT COMPLETED | Sirolimus | 1 |
Source ClinicalTrials.gov
Adverse events3
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 | Gastrointestinal disorders | Gastrointestinal disorders | Sirolimus | 4 | 4 | 14 |
| other | Skin problems | Skin and subcutaneous tissue disorders | Sirolimus | 3 | 4 | 5 |
| serious | Desmoid tumor | Musculoskeletal and connective tissue disorders | Sirolimus | 1 | 4 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sirolimus | 0 | 4 |
| Total, other adverse events | Sirolimus | 4 | 4 |
| Total, serious adverse events | Sirolimus | 1 | 4 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33376109 | DERIVED |
Source PubMed
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/NCT03095703
GET https://conductscience.org/api/trials/v1/NCT03095703/registered