Clinical trial · Observational
A Pilot Study to Explore the Role of Gut Flora in Colorectal Cancer
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Colorectal Cancer
NCT04148378CI-TRIAL-00090627withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Company shifted focus
Summary
Brief summary (as posted)
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding colorectal cancer.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenocarcinoma | Colorectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer Metastatic | — | UNRESOLVED | — |
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colorectal Sarcoma | Colorectal Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients
- description
- Patients who have been diagnosed with colorectal cancer.
- interventionNames
- Other: No intervention
Primary outcomes (1)
- measure
- Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
- timeFrame
- One year
- description
- Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific gastrointestinal disease types.
Secondary outcomes (1)
- measure
- Validation of Sequencing Methods
- timeFrame
- One year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study 2. Male or female patients of any age (interest is given to children to compare with mothers). 3. Diagnosis of colorectal cancer Exclusion Criteria: 1. Refusal to sign informed consent form 2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. Postoperative stoma, ostomy, or ileoanal pouch 4. Participation in any experimental drug protocol within the past 12 weeks 5. Treatment with total parenteral nutrition 6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial 7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
References
Publications (0)
Data not yet available
No reference posted for this study.