Clinical Stage I Cutaneous Melanoma AJCC v8Phase 1NCT04875728
The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma
A Phase 1 study testing Cefazolin and Resection in people with Clinical Stage I Cutaneous Melanoma AJCC v8 and Clinical Stage IA Cutaneous Melanoma AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Stage I Cutaneous Melanoma AJCC v8, Clinical Stage IA Cutaneous Melanoma AJCC v8, Clinical Stage IB Cutaneous Melanoma AJCC v8
- What is being tested?
- Cefazolin and Resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2020to 2 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects with early stage melanoma (stage I-II)
- Patients must be undergoing wide local excision +/- sentinel lymph node biopsy
- Patients must be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Who cannot join
- Use of antibiotics within the three months prior to surgery
- Allergy, sensitivity or anaphylaxis to beta-lactam or cephalosporin antibiotics
- Presence of an infection at the time of surgery
- Increased risk of infection due to a co-existing medical condition as determined by the surgical team or principal investigator (PI)
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration
- American Society of Anesthesiologists (ASA) grade > IV
- Refusal to participate in the study
- Patients who are pregnant will not be included in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Impact of Perioperative Antibiotic Prophylaxis on the Microbiome in Patients With Cutaneous Malignancy
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To investigate whether the use of pre-operative prophylactic antibiotics administered during surgical resection substantially alters the patient's gut microbiome.
SECONDARY OBJECTIVES:
- To characterize the dynamics of the immune response to surgical intervention in the absence and presence of pre-operative prophylactic antibiotics, focusing on the immune profile of the peripheral blood leukocytes as well as the balance of circulating pro- and anti-inflammatory cytokines and metabolomic profiles.
II. To assess surgical site infection (SSI) in the absence and presence of pre-operative prophylactic antibiotics at time of surgical resection.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive cefazolin intravenously (IV) and then undergo standard of care surgical resection within 1 hour.
ARM B: Patients undergo standard of care surgical resection.
After completion of study treatment, patients are followed up at 3 days, 2 weeks, and 3 months.
- Conditions
- Clinical Stage I Cutaneous Melanoma AJCC v8, Clinical Stage IA Cutaneous Melanoma AJCC v8, Clinical Stage IB Cutaneous Melanoma AJCC v8, Clinical Stage II Cutaneous Melanoma AJCC v8, Clinical Stage IIA Cutaneous Melanoma AJCC v8, Clinical Stage IIB Cutaneous Melanoma AJCC v8
- Being tested
- Cefazolin, Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
Given IV
ResectionProcedure or surgery
Also called Surgical Resection
Undergo standard of care surgical resection
| Study group | Role | What they receive |
|---|---|---|
| Arm A (cefazolin, surgical resection) | Active comparator | Patients receive cefazolin IV and then undergo standard of care surgical resection within 1 hour. Receives: Drug: Cefazolin; Procedure: Resection |
| Arm B (surgical resection) | Experimental | Patients undergo standard of care surgical resection. Receives: Procedure: Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microbiome alpha diversity
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 (alpha-diversity), we will count each operational taxonomic unit (OTU) or amplicon sequence variant (ASV) identified. Richness count is expected to range between 10-500 per sample.
Measured: Baseline up to 2 weeks post-surgery
Secondary outcomes (4)
Change in relative abundance of microbes
Measured: Baseline, at 2 weeks post-surgery, and 3 months post-surgery
Change in microbiome diversity
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 (alpha-diversity), we will count each operational taxonomic unit (OTU) or amplicon sequence variant (ASV) identified. Richness count is expected to range between 10-500 per sample.
Measured: Baseline up to 3 months post-surgery
Wound (surgical site) infection rate
Measured: Up to 3 months post-surgery
Profiling of systemic immune function by analysis of composition of circulating immune cell populations and cytokines
By analysis of composition of circulating immune cell populations and cytokines.
Measured: Up to 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start8 Sep 2020
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage I Cutaneous Melanoma AJCC v8Studies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Emily Z Keung, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875728
- Sponsor's protocol ID
- 2020-0265
- Other IDs
- NCI-2020-07071, 2020-0265
- Status last verified
- May 2026
- First submitted
- 5 Oct 2020
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Perioperative Antibiotic Prophylaxis on the Microbiome in Patients With Cutaneous Malignancy
- ClinicalTrials.gov ID
- NCT04875728
- Acronym / sponsor ID
- 2020-0265
- Conditions
- Clinical Stage I Cutaneous Melanoma AJCC v8, Clinical Stage IA Cutaneous Melanoma AJCC v8, Clinical Stage IB Cutaneous Melanoma AJCC v8, Clinical Stage II Cutaneous Melanoma AJCC v8, Clinical Stage IIA Cutaneous Melanoma AJCC v8, Clinical Stage IIB Cutaneous Melanoma AJCC v8
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To investigate whether the use of pre-operative prophylactic antibiotics administered during surgical resection substantially alters the patient's gut microbiome.
SECONDARY OBJECTIVES:
- To characterize the dynamics of the immune response to surgical intervention in the absence and presence of pre-operative prophylactic antibiotics, focusing on the immune profile of the peripheral blood leukocytes as well as the balance of circulating pro- and anti-inflammatory cytokines and metabolomic profiles.
II. To assess surgical site infection (SSI) in the absence and presence of pre-operative prophylactic antibiotics at time of surgical resection.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive cefazolin intravenously (IV) and then undergo standard of care surgical resection within 1 hour.
ARM B: Patients undergo standard of care surgical resection.
After completion of study treatment, patients are followed up at 3 days, 2 weeks, and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (cefazolin, surgical resection) | Active comparator | Drug: Cefazolin, Procedure: ResectionPatients receive cefazolin IV and then undergo standard of care surgical resection within 1 hour. |
| Arm B (surgical resection) | Experimental | Procedure: ResectionPatients undergo standard of care surgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult subjects with early stage melanoma (stage I-II)
- Patients must be undergoing wide local excision +/- sentinel lymph node biopsy
- Patients must be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Key exclusion criteria (8 listed)
- Use of antibiotics within the three months prior to surgery
- Allergy, sensitivity or anaphylaxis to beta-lactam or cephalosporin antibiotics
- Presence of an infection at the time of surgery
- Increased risk of infection due to a co-existing medical condition as determined by the surgical team or principal investigator (PI)
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CefazolinGiven IV | Drug | Arm A (cefazolin, surgical resection) |
| ResectionAlso: Surgical ResectionUndergo standard of care surgical resection | Procedure or surgery | Arm A (cefazolin, surgical resection), Arm B (surgical resection) |
Primary outcome
Change in microbiome alpha diversity
Time frame: Baseline up to 2 weeks post-surgery
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 (alpha-diversity), we will count each operational taxonomic unit (OTU) or amplicon sequence variant (ASV) identified. Richness count is expected to range between 10-500 per sample.
4 secondary outcomes
Change in relative abundance of microbes
Time frame: Baseline, at 2 weeks post-surgery, and 3 months post-surgery
Change in microbiome diversity
Time frame: Baseline up to 3 months post-surgery
Wound (surgical site) infection rate
Time frame: Up to 3 months post-surgery
Profiling of systemic immune function by analysis of composition of circulating immune cell populations and cytokines
Time frame: Up to 3 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Z Keung principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cefazolin and Resection in people with Clinical Stage I Cutaneous Melanoma AJCC v8 and Clinical Stage IA Cutaneous Melanoma AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microbiome alpha diversity (time frame: Baseline up to 2 weeks post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.