Trial · NCT01655719
Pioglitazone in Thyroid Cancers
NCT01655719, Phase 2, Completed, University of Michigan; results first posted 2017-10-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pioglitazone in Thyroid Cancers. Trials, record NCT01655719. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01655719
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pioglitazone in Thyroid Cancers
- NCT number
- NCT01655719
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- Thyroid Cancers That Contain the PAX8-PPARgamma Fusion Gene
- Interventions
- Pioglitazone
- First posted
- 2012-08-02
- Last updated
- 2017-10-26
- Results first posted
- 2017-10-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tumor Response (Change) | Baseline and 24 weeks | Response is measured by change in Tumor size (cm) |
| Secondary | Change in Serum Thyroglobulin | Baseline and 24 weeks | Determine if pioglitazone decreases serum thyroglobulin in patients with follicular-patterned thyroid carcinomas that contain the PAX8-PPARgamma fusion gene. |
| Secondary | Toxicity | 24 weeks | Toxicities experienced by patients with PAX8-PPARgamma fusion gene-positive follicular-patterned thyroid carcinomas treated with pioglitazone are indicated by presence of Serious Adverse Events (that show relatedness). |
| Other | Biomarkers | 24 weeks | Define predictive markers of response or insensitivity to pioglitazone. Unstained tumor tissue slides from archival paraffin blocks, fresh biopsy specimens from measurable metastases, and blood samples (serum and peripheral blood cells) will be collected on enrolled patients who consented for the optional correlative studies. These will be used to identify factors that predict efficacy of pioglitazone. Analyses may include measures of expression of specific RNAs and proteins, and DNA sequence analysis. |
| Other | Sensitization to Radioiodine Therapy | 24 weeks | Determine if pioglitazone induces a clinically significant level of radioiodine uptake in the residual thyroid carcinoma, and if so, whether there is a therapeutic response to radioiodine. This will be addressed in a separate follow-up protocol available to subjects completing this study. |
| Other | Lipid Accumulation in Tumor | 24 weeks | Determine (by MRI) if pioglitazone induces lipid accumulation in follicular-patterned thyroid carcinomas that contain the PAX8-PPARgamma fusion gene. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tumor Response (Change) | Baseline and 24 weeks | cm | NUMBER | |
| SECONDARY | Change in Serum Thyroglobulin | Baseline and 24 weeks | ng/mL | NUMBER | |
| SECONDARY | Toxicity | 24 weeks | serious adverse events | NUMBER | |
| OTHER_PRE_SPECIFIED | Biomarkers | 24 weeks | |||
| OTHER_PRE_SPECIFIED | Sensitization to Radioiodine Therapy | 24 weeks | |||
| OTHER_PRE_SPECIFIED | Lipid Accumulation in Tumor | 24 weeks |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tumor Response (Change) | Pioglitazone Treatment | Baseline | 6.0 | cm | |
| Tumor Response (Change) | Pioglitazone Treatment | 24 weeks | 3.9 | cm | |
| Change in Serum Thyroglobulin | Pioglitazone Treatment | Baseline | 1974 | ng/mL | |
| Change in Serum Thyroglobulin | Pioglitazone Treatment | 24 weeks | 49.4 | ng/mL | |
| Toxicity | Pioglitazone Treatment | 0 | serious adverse events |
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 | Pioglitazone Treatment | 1 | |
| Overall Study | COMPLETED | Pioglitazone Treatment | 1 | |
| Overall Study | NOT COMPLETED | Pioglitazone Treatment | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pioglitazone Treatment | 0 | 1 |
| Total, other adverse events | Pioglitazone Treatment | 0 | 1 |
| Total, serious adverse events | Pioglitazone Treatment | 0 | 1 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29373711 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| R01CA166033 | In vivo therapy and mechanisms of PAX8-PPARgamma thyroid cancer | KOENIG, RONALD JAY | UNIVERSITY OF MICHIGAN AT ANN ARBOR | NATIONAL CANCER INSTITUTE | 2013 to 2017 |
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/NCT01655719
GET https://conductscience.org/api/trials/v1/NCT01655719/registered