Trial · NCT00971789
Sirolimus to Treat Cowden Syndrome and Other PTEN Hamartomatous Tumor Syndromes
NCT00971789, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-07-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sirolimus to Treat Cowden Syndrome and Other PTEN Hamartomatous Tumor Syndromes. Trials, record NCT00971789. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00971789
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sirolimus to Treat Cowden Syndrome and Other PTEN Hamartomatous Tumor Syndromes
- NCT number
- NCT00971789
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Cowden's Disease, Hamartoma Syndrome, Multiple
- Interventions
- fludeoxyglucose F 18, sirolimus, Clinical Videography
- First posted
- 2009-09-04
- Last updated
- 2015-09-30
- Results first posted
- 2013-07-19
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Biochemical Changes in Benign and Malignant Tumor Tissues as Assessed by Immunohistochemistry. | Baseline, day 14, and day 56 | A biochemical change is defined as a decrease in certain protein levels (e.g. P-AKT (phosphorylated AKT), total S6, P-S6, and P-4E-BP1) important in cell growth. These are measured by collecting tissue samples which stained and protein levels are measured under the microscope. Scoring will be based on distribution and intensity of staining. Distribution will be scored as 0 (0%), 1 (1% to 50%), and 2 (51% to 100%) to indicate the percentage of positive cells of interest in a single core. The intensity of the signal will be scored as 1 (weak), 2 (moderate), and 3 (strong). The distribution score and intensity score will be summed into a total score (TS). |
| Primary | Number of Participants With Adverse Events | 47 months | Here is the number of participants with adverse events |
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 | Biochemical Changes in Benign and Malignant Tumor Tissues as Assessed by Immunohistochemistry. | Baseline, day 14, and day 56 | No patient underwent biopsy after the study treatment, so no such tissue analysis was done. | ||
| PRIMARY | Number of Participants With Adverse Events | 47 months | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | Sirolimus Patients | 17 | 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 Patients | 18 | |
| Overall Study | COMPLETED | Sirolimus Patients | 18 | |
| Overall Study | NOT COMPLETED | Sirolimus Patients | 0 |
Source ClinicalTrials.gov
Adverse events62
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 | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Sirolimus Patients | 7 | 18 | 12 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | Sirolimus Patients | 3 | 18 | 5 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Sirolimus Patients | 7 | 18 | 9 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | Sirolimus Patients | 5 | 18 | 5 |
| other | Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | Sirolimus Patients | 2 | 18 | 3 |
| other | Blood/Bone Marrow - Other (anemia) | Blood and lymphatic system disorders | Sirolimus Patients | 1 | 18 | 1 |
| other | CD4 count | Blood and lymphatic system disorders | Sirolimus Patients | 1 | 18 | 1 |
| other | Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | Sirolimus Patients | 2 | 18 | 2 |
| other | Cholesterol, serum-high (hypercholesteremia) | Metabolism and nutrition disorders | Sirolimus Patients | 5 | 18 | 5 |
| other | Constipation | Gastrointestinal disorders | Sirolimus Patients | 4 | 18 | 4 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sirolimus Patients | ||
| Total, other adverse events | Sirolimus Patients | 17 | 18 |
| Total, serious adverse events | Sirolimus Patients | 0 | 18 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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/NCT00971789
GET https://conductscience.org/api/trials/v1/NCT00971789/events?page=2