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NCT05368688 · ClinicalTrials.gov registry record
Microbiome in Colorectal Cancer Onset and Progression
A clinical trial, sponsored by Viome.
- Terminated
- Registry status
- 63
- Enrollment target
NCT05368688: Clinical Trial study, sponsored by Viome.
NCT05368688 is a clinical trial that was terminated before completion, run by Viome. The registered enrollment target is 63 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05368688 was terminated before completion, sponsored by Viome.
- TERMINATED
- Registry status
- 63 participants
- Enrollment target
Study Summary
This is an observational study with the goal to improve the robustness of the scientific evidence linking Fusobacterium nucleatum (Fn) and/or other microorganisms to colorectal cancer (CRC) onset and/or progression. This is an approximately three-year study. There are two phases to this study, including: 1) pilot phase, 2) full study. There are also five arms in this study including cancer-free, pre-cancerous, and Colorectal cancer stages (I-III). The pilot study will include the recruitment of 50 participants per group (i.e., total of 250 participants). The full study will have an additional 150 participants per group (total of 1,000 participants). This study will recruit using clinical sites in the United States. There are 5 timepoints in this study. If the participants are found to be medically eligible through diagnosis and medical information, they will provide samples (including: saliva, blood, urine, stool and tumor biopsy) at each timepoint and during the study. They will also answer health and wellness questions during this study. Additional data collection, including medical data, biopsies and other biological samples might happen at interim timepoints in case of adenoma/cancer disease progression (recurrence, metastasis). The participant's healthcare provider will determine if additional biopsies are required as a part of the standard of care. If collected, additional samples will be sent for research purposes.
Primary Outcome
Determine Fn species and strains, more specifically the prevalence and relative activity, and the differential gene expression and key pathways. The Investigators will also look at Microbial co-occurrence/abundance with Fn and local tumor microenvironment and tumor marker/mutations and their association with microbiome.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2022-06-30 |
| Est. Completion | 2022-12-22 |
Why NCT05368688 stopped before completion
NCT05368688 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 63 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT05368688 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05368688 about?
NCT05368688 is a clinical study titled "Microbiome in Colorectal Cancer Onset and Progression". This is an observational study with the goal to improve the robustness of the scientific evidence linking Fusobacterium nucleatum (Fn) and/or other microorganisms to colorectal cancer (CRC) onset and/or progression. This is an approximately three-year study. There are two phases to this study, inclu...
What is the current status of trial NCT05368688?
This trial is currently terminated. The enrollment target is 63 participants. The study started on 2022-06-30. Estimated completion is 2022-12-22.
Who is sponsoring clinical trial NCT05368688?
This trial is sponsored by Viome, which has 18 total clinical trials registered on ClinicalTrials.gov.
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