Trial · NCT03796884
Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
NCT03796884, Phase 2, Active not recruiting, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer. Trials, record NCT03796884. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03796884
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
- NCT number
- NCT03796884
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 150 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Conditions
Colorectal Adenoma, Stage 0 Colorectal Cancer AJCC v8, Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage IIA Colorectal Cancer AJCC v8, Stage IIB Colorectal Cancer AJCC v8, Stage IIC Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8
- Interventions
- Linaclotide, Placebo
- First posted
- 2019-01-08
- Last updated
- 2026-10-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacodynamics effect on cGMP levels | Up to 2 years, plus an additional 12 months for primary analysis | Will compare cGMP levels in adenomas between study arms using a two-sample t-test (alpha=.05; two-sided) or Wilcoxon rank sum test. |
| Secondary | Incidence of adverse events (AEs) | From the time of first dose of linaclotide or placebo until resolution, if related to linaclotide, or through 30 days after occurrence | All participants will be evaluated for toxicity. Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be used to summarize adverse events associated with linaclotide. |
| Secondary | Ki-67 expression | Up to 2 years | Wilcoxon rank sum test will be used to compare Ki-67 expression in adenomas across arms. |
| Secondary | GUCY2C expression | Up to 2 years | Wilcoxon rank sum and Fisher's exact tests will be used to compare GUCY2C expression between study arms. |
| Secondary | Guanylin levels | Up to 2 years | Wilcoxon rank sum and Fisher's exact tests will be used to compare guanylin levels between study arms. |
| Other | VASP serine 239 phosphorylation | Up to 2 years | Assessed by immunoblot analysis. Wilcoxon rank sum and Fisher's exact tests will be used to compare VASP phosphorylation between study arms. |
| Other | Beta-catenin levels | Up to 2 years | Assessed by immunoblot analysis. Wilcoxon rank sum and Fisher's exact tests will be used to compare beta-catenin accumulation and downstream signaling between study arms. |
| Other | Beta-catenin nuclear localization | Up to 2 years | Assessed by immunofluorescence. Wilcoxon rank sum and Fisher's exact tests will be used to compare beta-catenin accumulation and downstream signaling between study arms |
| Other | Axin and c-Myc messenger ribonucleic acid (mRNA) levels | Up to 2 years | Assessed by quantitative reverse transcriptase-polymerase chain reaction. Wilcoxon rank sum and Fisher's exact tests will be used to compare axin and c-Myc mRNA levels between study arms. |
| Other | PCNA expression | Up to 2 years | Assessed by immunofluorescence. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03796884
GET https://conductscience.org/api/trials/v1/NCT03796884/registered