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Trial · NCT00503035

Molecular Targeting of 15-Lipoxygenase-1 (15-LOX-1) for Apoptosis Induction in Human Colorectal Cancers

NCT00503035, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2023-02-13

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Molecular Targeting of 15-Lipoxygenase-1 (15-LOX-1) for Apoptosis Induction in Human Colorectal Cancers. Trials, record NCT00503035. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00503035

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Molecular Targeting of 15-Lipoxygenase-1 (15-LOX-1) for Apoptosis Induction in Human Colorectal Cancers
NCT number
NCT00503035
Status
Completed
Phases
Phase 2
Enrollment
51 participants, actual
Lead sponsor
M.D. Anderson Cancer Center
Conditions
Familial Adenomatous Polyposis
Interventions
Celecoxib, Colonoscopy Biopsy
First posted
2007-07-18
Last updated
2023-02-13
Results first posted
2023-02-13

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primary13-HODE Colonic Tissue LevelsBaseline to post 6 months of celecoxib treatment13-HODE colonic tissue levels measured by Liquid chromatography and tandem mass spectrometry measurements (LC/MS/MS) in colorectal normal and polyp tissues
SecondaryPGE2 Colonic Tissue Levels
at the baseline colonoscopy (or sigmoidoscopy in patients who had undergone colectomy) before the initiation of celecoxib, and the follow-up colonoscopy or sigmoidoscopy was performed after celecoxib treatment (month 6)
PGE2 colonic tissue levels measured by Liquid chromatography and tandem mass spectrometry measurements (LC/MS/MS) in colorectal normal and polyp tissues

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARY13-HODE Colonic Tissue LevelsBaseline to post 6 months of celecoxib treatmentng/mg tissue proteinMEAN
SECONDARYPGE2 Colonic Tissue Levels
at the baseline colonoscopy (or sigmoidoscopy in patients who had undergone colectomy) before the initiation of celecoxib, and the follow-up colonoscopy or sigmoidoscopy was performed after celecoxib treatment (month 6)
ng/mg tissue proteinMEAN

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
13-HODE Colonic Tissue LevelsCelecoxibpolyps before celecoxib treatment14.56Standard Deviation 9.93ng/mg tissue protein
13-HODE Colonic Tissue LevelsCelecoxibpolyps after celecoxib treatment18.83Standard Deviation 14ng/mg tissue protein
13-HODE Colonic Tissue LevelsCelecoxibNormal: before celecoxib treatment23.02Standard Deviation 18.55ng/mg tissue protein
13-HODE Colonic Tissue LevelsCelecoxibNormal: after celecoxib treatment20.03Standard Deviation 11.7ng/mg tissue protein
PGE2 Colonic Tissue LevelsCelecoxibPolyps: before celecoxib treatment14.71Standard Deviation 6.95ng/mg tissue protein
PGE2 Colonic Tissue LevelsCelecoxibPolyps: after celecoxib treatment20.62Standard Deviation 10.48ng/mg tissue protein
PGE2 Colonic Tissue LevelsCelecoxibNormal: before celecoxib treatment21.48Standard Deviation 14.32ng/mg tissue protein
PGE2 Colonic Tissue LevelsCelecoxibNormal: after celecoxib treatment24.99Standard Deviation 18.25ng/mg tissue protein

Participant flow3

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDCelecoxib47
Overall StudyCOMPLETEDCelecoxib27
Overall StudyNOT COMPLETEDCelecoxib20

Adverse events41

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAbdominal painGastrointestinal disordersCelecoxib532
otherAllergic ReactionSkin and subcutaneous tissue disordersCelecoxib232
otherAnorexiaGastrointestinal disordersCelecoxib132
otherRectal bleedingGastrointestinal disordersCelecoxib432
otherBlurred visionEye disordersCelecoxib132
otherBruisingBlood and lymphatic system disordersCelecoxib232
otherConstipationGastrointestinal disordersCelecoxib232
otherCoughRespiratory, thoracic and mediastinal disordersCelecoxib232
otherCrampingGastrointestinal disordersCelecoxib132
otherDiarrheaGastrointestinal disordersCelecoxib132

Adverse event totals3

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityCelecoxib032
Total, other adverse eventsCelecoxib2432
Total, serious adverse eventsCelecoxib232

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
23332604BACKGROUNDPubMed
34610992BACKGROUNDPubMed

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
R01CA1065775-LOX-1 and Clinical Chemoprevention of Colon TumorsSHUREIQI, IMADUNIVERSITY OF TX MD ANDERSON CAN CTRNATIONAL CANCER INSTITUTE2005 to 2008

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT00503035

GET https://conductscience.org/api/trials/v1/NCT00503035/events?page=2