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Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04245150
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:
Microorganisms in the human body (such as virus, bacteria, fungus) may have an important role in breast cancer side effects. In this study, microorganisms will be analyzed to determine which, if any,are present. It will then be determined if side effects from breast radiation are associated with these microorganisms. Understanding the association of microorganisms with side effects will allow the study team to look at strategies to reduce side effects for patients undergoing radiation to the breast.

Condition or disease Intervention/treatment
DCIS Invasive Breast Cancer Other: Stool sample Other: Skin Swab Sample

Detailed Description:

This study will prospectively enroll 50 participants with with biopsy proven Ductal carcinoma in situ (DCIS) or invasive breast cancer 18 years of age or older, undergoing breast conserving surgery and adjuvant radiation therapy at Cleveland Clinic.

Each participant will have a post-surgery pre-radiotherapy stool and breast skin sample obtained, complete a medical record review for clinical data, and have complete an interview/questionnaire in order to learn about potential risk factors which will be included in the data collection form. Included information will include Stage (T, N, M, composite), receipt of chemotherapy, radiation fields and dose, BMI, hypertension (HTN), Diabetes Mellitus (DM), smoking status, history of breast infection yes/no (Data Collection Form).

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity
Actual Study Start Date : January 10, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Ductal Carcinoma In Situ (DCIS) or invasive breast cancer
Participants with DCIS or invasive breast cancer
Other: Stool sample
Stool sample

Other: Skin Swab Sample
Skin Swab Sample




Primary Outcome Measures :
  1. Microbiome profile as assessed by stool sample [ Time Frame: At baseline ]
    Microbiome profile as assessed by stool sample. Sample analysis will be done via DNA extraction and rRNA gene sequencing of stool sample

  2. Microbiome profile as assessed by breast skin sample [ Time Frame: At baseline ]
    Microbiome profile as assessed by breast skin sample. Sample analysis will be done via DNA extraction and rRNA gene sequencing of stool sample

  3. Correlation of the microbiome to incidence of at least grade 3 skin toxicity using the CTCAE version 4.0 scoring [ Time Frame: 3 months post-treatment ]

    The microbiome profiles identified will be correlated with incidence of at least grade 3 skin toxicity using the CTCAE version 4.0 scoring by visual assessment. Maximum toxicity during radiation will be recorded.

    Grade 0: None Grade 1: Faint erythema or dry desquamation Grade 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema Grade 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion Grade 4: Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated



Biospecimen Retention:   Samples With DNA
Breast skin and GI samples from participants with breast cancer following breast conserving surgery will be collected. These samples will then be analyzed using DNA extraction and 16S rRNA gene sequencing with an in-house bioinformatics group. Data will be used to define the microbiome profile for this subset of breast cancer patients.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Patients with biopsy proven DCIS or invasive breast cancer, 18 years of age or older, undergoing breast conserving surgery and adjuvant radiation therapy at Cleveland Clinic.
Criteria

Inclusion Criteria:

  • Breast cancer patients with DCIS or invasive breast cancer
  • Undergoing breast conserving surgery and adjuvant radiation
  • Subjects must be willing and able to provide breast skin samples

Exclusion Criteria:

  • Active clinical breast infection (on antiobiotic for skin/breast infection or clinical diagnosis)
  • Refuse or are unable to sign informed consent form
  • Past history of breast cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04245150


Contacts
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Contact: Chirag Shah, MD 1-866-223-8100 TaussigResearch@ccf.org

Locations
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United States, Ohio
Cleveland Clinic, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Chirag Shah    866-223-8100    TaussigResearch@ccf.org   
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Chirag Shah, MD The Cleveland Clinic
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04245150    
Other Study ID Numbers: CASE5118
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: July 13, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases