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The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma

Primary Purpose

Clinical Stage I Cutaneous Melanoma AJCC v8, Clinical Stage IA Cutaneous Melanoma AJCC v8, Clinical Stage IB Cutaneous Melanoma AJCC v8

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cefazolin
Resection
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinical Stage I Cutaneous Melanoma AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A (cefazolin, surgical resection)

Arm B (surgical resection)

Arm Description

Patients receive cefazolin IV and then undergo standard of care surgical resection within 1 hour.

Patients undergo standard of care surgical resection.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in relative abundance of microbes
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.
Wound (surgical site) infection rate
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.

Full Information

First Posted
October 5, 2020
Last Updated
May 1, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04875728
Brief Title
The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma
Official Title
Evaluating the Impact of Perioperative Antibiotic Prophylaxis on the Microbiome in Patients With Cutaneous Malignancy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
PRIMARY OBJECTIVE: I. To investigate whether the use of pre-operative prophylactic antibiotics administered during surgical resection substantially alters the patient's gut microbiome. SECONDARY OBJECTIVES: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Clinical Stage IIC Cutaneous Melanoma AJCC v8, Pathologic Stage I Cutaneous Melanoma AJCC v8, Pathologic Stage IA Cutaneous Melanoma AJCC v8, Pathologic Stage IB Cutaneous Melanoma AJCC v8, Pathologic Stage II Cutaneous Melanoma AJCC v8, Pathologic Stage IIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIC Cutaneous Melanoma AJCC v8

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A (cefazolin, surgical resection)
Arm Type
Active Comparator
Arm Description
Patients receive cefazolin IV and then undergo standard of care surgical resection within 1 hour.
Arm Title
Arm B (surgical resection)
Arm Type
Experimental
Arm Description
Patients undergo standard of care surgical resection.
Intervention Type
Drug
Intervention Name(s)
Cefazolin
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Resection
Other Intervention Name(s)
Surgical Resection
Intervention Description
Undergo standard of care surgical resection
Primary Outcome Measure Information:
Title
Change in microbiome alpha diversity
Description
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.
Time Frame
Baseline up to 2 weeks post-surgery
Secondary Outcome Measure Information:
Title
Change in relative abundance of microbes
Time Frame
Baseline, at 2 weeks post-surgery, and 3 months post-surgery
Title
Change in microbiome diversity
Description
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.
Time Frame
Baseline up to 3 months post-surgery
Title
Wound (surgical site) infection rate
Time Frame
Up to 3 months post-surgery
Title
Profiling of systemic immune function by analysis of composition of circulating immune cell populations and cytokines
Description
By analysis of composition of circulating immune cell populations and cytokines.
Time Frame
Up to 3 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Z Keung
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma

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