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NCT04875728 · ClinicalTrials.gov registry record · Phase 1
The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma
A Phase 1 study of Clinical Stage IA Cutaneous Melanoma AJCC v8 and Clinical Stage IB Cutaneous Melanoma AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04875728: Active Phase 1 study of Clinical Stage IA Cutaneous Melanoma AJCC v8 and Clinical Stage IB Cutaneous Melanoma AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT04875728 is a Phase 1 study of Clinical Stage IA Cutaneous Melanoma AJCC v8 and Clinical Stage IB Cutaneous Melanoma AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 20 participants, below the 749-participant average among 4 other Clinical Stage IA Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04875728, a Phase 1 study of Clinical Stage IA Cutaneous Melanoma AJCC v8 and Clinical Stage IB Cutaneous Melanoma AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial investigates the impact of cefazolin before surgery on the microbiome in patients with stage I-II melanoma. Antibiotics, such as cefazolin, given at the time of surgery may cause a significant change in the microbes (like bacteria and viruses) found in the stomach and intestines. This trial may help researchers learn if any changes in microbes affect the body's ability to respond to surgery and cancer.
Primary Outcome
The diversity, structure, and composition of the fecal microbiome will be determined by 16S(v4) rRNA gene sequencing. 16S profiles will be used to compute alpha diversity, beta diversity, and the relative abundance of fecal bacteria. The composition of fecal bacteria in adult humans is mainly dominated by members of the Firmicutes and Proteobacteria phyla while members of Proteobacteria, Actinobacteria, Fusobacteria, and Verrucomicrobia are observed in lower abundance. To calculate richness (alp
Conditions Studied
Interventions
- PROCEDURE Resection
- DRUG Cefazolin
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-09-08 |
| Est. Completion | 2027-02-02 |
| Phase | Phase 1 |
What the registry record for NCT04875728 still lists
NCT04875728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 749-participant average among 4 other Clinical Stage IA Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (97% lower).
The record links to 10 conditions, with Clinical Stage IA Cutaneous Melanoma AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Resection is the first listed.
NCT04875728 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04875728 about?
NCT04875728 is a clinical study titled "The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma". This phase I trial investigates the impact of cefazolin before surgery on the microbiome in patients with stage I-II melanoma. Antibiotics, such as cefazolin, given at the time of surgery may cause a significant change in the microbes (like bacteria and viruses) found in the stomach and intestines. ...
What is the current status of trial NCT04875728?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-09-08. Estimated completion is 2027-02-02.
What conditions does trial NCT04875728 study?
This clinical trial studies the following conditions: Clinical Stage IA Cutaneous Melanoma AJCC v8, Clinical Stage IB Cutaneous Melanoma AJCC v8, Clinical Stage I Cutaneous Melanoma AJCC v8, Clinical Stage II Cutaneous Melanoma AJCC v8, Clinical Stage IIB Cutaneous Melanoma AJCC v8.
What interventions are being tested in trial NCT04875728?
The interventions under investigation include: Resection (PROCEDURE), Cefazolin (DRUG).
Who is sponsoring clinical trial NCT04875728?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04875728 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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